The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.
In today's Report: FDA authorizes new at-home test, expands Pfizer-BioNTech vaccine authorization, and hosts workshop on recombinant protein-based vaccines; Senate weighs reauthorizing PAHPA; HHS urged to end federal worker vaccine mandate; CMS posts new fact sheet on coverage; and Miriam Gundt shares why diversity in IP is essential to advancement and innovations.
On Monday, the U.S. Food and Drug Administration (FDA) authorized the OTC COVID-19 antigen diagnostic test “Status COVID-19 Antigen Rapid Test for Home Use,” manufactured by Princeton BioMeditech Corp. FDA has also authorized additional uses of the Pfizer-BioNTech COVID-19 vaccine in pediatric populations, including authorizing a fourth dose administered at least 1 month following the most recent dose, and additional doses that may be administered at the discretion of the healthcare provider. On Thursday, the Biomedical Advanced Research and Development Authority (BARDA) and FDA hosted a workshop on “Recombinant Protein-Based COVID-19 Vaccines.” As the COVID-19 Public Health Emergency is set to end on May 11 in the U.S., the Centers for Medicare & Medicaid Services (CMS) published a Consumer Fact Sheet on COVID-19 tests, noting changes for insurance coverage under Medicare, Medicaid, the Children’s Health Insurance Program, and private insurance. In a proposed rule released Friday, CMS said the Medicare Diabetes Prevention Program’s telehealth and other COVID-19 flexibilities should continue throughout 2023 and beyond the public health emergency declaration. (Authored by Randy Prebula)
On Thursday, the U.S. Senate HELP Committee will hold a hearing on “preparing for the next public health emergency” and on reauthorizing the Pandemic and All-Hazards Preparedness Act. House Ways & Means Committee Vice Chairman Vern Buchanan (R-FL) led a letter with Rep. Jeff Duncan (R-SC) to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure to urge them to end the COVID-19 vaccine mandate on America’s health care workers when the public health emergency ends on May 11. In a hearing last week, HRSA Administrator Carole Johnson defended the Biden administration's use of the $178 billion COVID-19 Provider Relief Fund to House appropriators. The CDC issued a new report on the “Effectiveness of Monovalent mRNA COVID-19 Vaccination in Preventing COVID-19 – Associated Invasive Mechanical Ventilation and Death Among Immunocompetent Adults During the Omicron Variant Period.” (Authored by Cybil Roehrenbeck)
To mark World IP Day and its theme of "Women and IP: Accelerating innovation and creativity," our Global head of IPMT, Miriam Gundt shared in an interview why diversity in IP is essential to advancement and innovations; her top three trends to focus on; and celebrates how IP has positively impacted society. Speaking on how IP rights have positively impacted society and encouraged innovation, Gundt noted that the struggles of the pandemic led to the accelerated development of vaccines, and as a result, new intellectual property.
The U.S. Food and Drug Administration (FDA) has issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will be revised to temporarily remain in effect, after the COVID-19 public health emergency (PHE) declaration expires on May 11, 2023. FDA is winding down the policies and operations that flowed from the COVID-19 pandemic and the related PHE declaration in March of 2020. This wind down effort will not just impact products that have been marketed under emergency use authorizations (EUAs) but will affect companies and products following FDA’s pandemic-related policies that may soon end. It will also allow FDA officials to assess which of those policies worked well and might be retained under the agency’s normal operations. Online here we have summarized FDA’s latest Notice as it pertains to pharmaceutical and biological products, and outlined how COVID-19-related drug and biologic EUAs may continue after the PHE expires. (Authored by Meredith Manning)
Yesterday, FDA authorized a bivalent-only COVID-19 shot regimen for most Americans ages 6 months and older and declared that Pfizer’s and Moderna’s two-dose monovalent COVID-19 regimens are no longer authorized for use in the U.S. Also yesterday, FDA held a webinar about the COVID-19 Transition Guidances for Medical Devices. On Monday, FDA issued an EUA for the Azure Fastep COVID-19 Antigen Pen Home Test. Last week, FDA issued an EUA for the use of InflaRx’s Gohibic (vilobelimab) injection for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (artificial life support). (Authored by Randy Prebula)
The Biden Administration intends to allow the COVID-19 public health emergency (PHE) to expire effective on May 11, 2023, which will have significant repercussions across the health care industry. During the PHE, the U.S Department of Health and Human Services (HHS), including the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG), implemented a number of waivers and flexibilities to account for the extraordinary circumstances of the COVID-19 pandemic. These emergency policies affected myriad federal health care program requirements, including telehealth requirements, physician supervision rules, provider and supplier enrollment requirements, Medicare Conditions of Participation, COVID-19 vaccine and diagnostic testing policies, and countless other policies affecting providers, laboratories, physicians, and health care plans. Emergency waivers and flexibilities also had significant downstream ramifications for drug and device manufacturers and other entities with businesses indirectly connected to federal health care programs. Many of these waivers and flexibilities will expire when the PHE ends or shortly thereafter. Some emergency policies are required by law to terminate immediately at the end of the PHE. For other policies, however, HHS has greater flexibility in phasing out the policy or — in certain cases — could elect to make the policy permanent even after the PHE expires. Online here we have highlighted some of the key HHS waivers or flexibilities tied to the PHE and the implications of the PHE expiration on these emergency policies. (Authored by James Huang)
Last week, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine. Also last week, FDA updated its “Medical Device Shortages During the COVID-19 Public Health Emergency” web page, reflecting changes to the device shortage list in durations for radiological devices, general plastic surgery devices, cardiac diagnostic, and monitoring products, general ICU/ hospital products, specimen collection testing supplies and equipment, and ventilators - ventilation-related products. FDA has finalized guidance on its “Enforcement Policy for Face Shields, Surgical Masks, and Respirators” during the COVID-19 PHE; this division of the previous version of the guidance does not affect the current policy and is intended only to facilitate a different timeline and process for transitioning back to normal operations, as further described in the Federal Register notice on this topic and on the COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders web page. (Authored by Randy Prebula)
On Monday, U.S. President Biden signed into law the COVID-19 Origin Act of 2023 (S. 619), a bill sponsored by Sen. Josh Hawley (R-MO) requiring Office of the Director of National Intelligence (ODNI) to declassify all information relating to potential links between the Wuhan Institute of Virology and the origin of COVID-19; now, the ODNI must submit to Congress an unclassified report with all such information with redactions only as necessary to protect sources and methods. Last week, the U.S. Centers for Disease Control and Prevention (CDC) receded the Requirements for Negative Pre-Departure COVID-19 Test Result or Documentation of Recovery From COVID-19 for Aircraft Passengers Traveling to the United States From the People's Republic of China. (Authored by Cybil Roehrenbeck)
On Monday, the U.S. Food and Drug Administration (FDA) revised the umbrella Emergency Use Authorization (EUA) for disposable, single-use surgical masks intended for use in health care settings by health care professionals during the COVID-19 pandemic, authorizing emergency use of only those surgical masks listed in the EUA’s Appendix A as of the date of this reissuance; as a result of this revision, the FDA will no longer be adding surgical mask models to Appendix A, and manufacturers who would like to bring new surgical masks to market should follow traditional premarket pathways, such as a premarket notification, or 510(k). Last week, FDA issued the draft guidance “Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens,” which provides drug manufacturers with recommendations for developing and implementing potency assays to ensure each lot of monoclonal antibodies (mAbs) or other therapeutic proteins is produced consistently with the potency necessary to achieve efficacy and that potency is maintained over the shelf life of the product. Also last week, FDA extended the expiration date for the Watmind USA Speedy Swab Rapid COVID-19 Ag Self-Test that is authorized under an EUA; information about at-home over-the-counter (OTC) COVID-19 diagnostic tests is online here. (Authored by Randy Prebula)
U.S. Republicans are preparing for increased COVID-19 scrutiny, including a hearing today to examine the origins of COVID-19, where former Centers for Disease Control and Prevention (CDC) Director Robert Redfield is scheduled to give testimony. Republicans are also continuing their quest to uncover the source of the virus, as the House Rules Committee will consider a bill (S. 619) that aims to "declassify any and all information" regarding connections between the Wuhan Institute and COVID-19. Sen. John Barrasso (R-WY) wrote a letter Energy Department Secretary Granholm concerning the DOE’s efforts to determine the origins of the COVID-19 pandemic. U.S. Rep. Josh Gottheimer (D-NJ) introduced the Rare Disease Clinical Trial Pandemic Disruption Act, saying it aims to encourage life sciences leaders to resume their delayed trials. House Energy and Commerce Committee members released a Request for Information (RFI) in preparation of the upcoming Pandemic and All Hazards Preparedness Act (PAHPA) reauthorization, due by September 30, 2023. Last week, U.S. Senators introduced a resolution purporting to ensure the President does not cede U.S. sovereignty to entities like the World Health Organization (WHO) by ratifying international pandemic agreements without Senate approval. CMS has published a fact sheet explaining “CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency.” Meanwhile, CDC has issued guidance for certifying COVID-19 deaths this past week. (Authored by Cybil Roehrenbeck)
Our 2023 edition of the Life Sciences and Health Care Horizons guide covers the key issues and trends that will shape the future of the industry. With perspectives from around the world in Asia-Pacific, Europe, Latin America and the U.S., our global team offers creative strategies for your most promising opportunities and integrated solutions that protect and support your business when issues arise. The guide discusses how the lingering impact of COVID-19 may bring challenges and opportunities for companies in the sector. Pandemic-related issues analyzed include the end of government public health emergency funding, the rise of compulsory licenses in the Eurasian Economic Union due to COVID-19, U.S. government contracting concerns, the sunset of emergency declarations, and the impact of the health crisis on the new EU pharmaceutical law package. (Authored by Steve Abrams, Lynn Mehler, and Jane Summerfield)
As the COVID-19 pandemic eased in many regions at the start of 2022, employers anticipated a return to “business as usual” and were focusing on how to balance employer expectations with employee demands for greater flexibility in their working lives. Twelve months on, adapting to hybrid working remains a challenge, but employers are less likely to view it as the key issue they face. In our 2023 UK “Employment Horizons” publication, we have reflected on some of the key themes impacting multi-national employers this past year. These include responding to inflationary pressures and the cost of living crisis, remote and flexible working after the pandemic, new regulations for contract work and employers’ use of AI, the social element of ESG initiatives, and the landscape surrounding sexual harassment claims. (Authored by Ed Bowyer)
The U.S. White House said Monday it plans to wind down a pair of COVID-19 emergency declarations on 11 May, ending the public health emergency (PHE) declaration at that time, as well as the Title 42 restrictions and expulsion measures at the U.S.-Mexico border. The statement was made in response to four COVID-19 bills offered by Republicans in the House this week, including: H.R. 497, which would undo COVID-19 mandates for health care workers in facilities that participate in Medicare and Medicaid; H.R. 382, which would end the PHE immediately; H.J. Res. 7 would immediately end the national emergency that accompanies the PHE; and H.R. 139, which would end remote work for federal employees and require executive agencies to submit plans to study the financial impact of telework policies. U.S. Rep. Andy Biggs (R-AZ) reintroduced a group of bills that address the COVID-19-related “overreach” on the American public; they would prohibit mask mandates on public transportation, and lift COVID-19 vaccine mandates for select groups, among other measures. This week, the U.S. House Committee on Oversight and Accountability will hold hearings on COVID-19 pandemic spending and waste, fraud, and abuse; and the House Energy & Commerce Committee, Oversight & Investigations Subcommittee will hold a hearing investigating the origins of infectious disease pandemics. (Authored by Cybil Roehrenbeck)
On Thursday, FDA’s Center for Devices and Radiological Health (CDRH) released its 2022 Annual Report highlighting the Center’s programmatic accomplishments, including the Pandemic Response. FDA issued a briefing document on Future Vaccination Regimens Addressing COVID-19. FDA’s vaccine advisory panel voted 21-0 Thursday to recommend the agency streamline future COVID-19 shots, making them the same composition regardless of whether they are given as first-time or booster shots; but panel members expressed some hesitation about moving to an annual booster shot for the general public like FDA is considering, pointing to knowledge gaps around long-term immunity and continued protection the current shots have against severe cases. The NIH National Science Advisory Board for Biosecurity voted on Jan. 27 to tentatively approve recommendations to strengthen oversight of research involving potentially dangerous pathogens, conditional on minor clarifying revisions after years of debate during the COVID-19 pandemic. (Authored by Randy Prebula)
In our quarterly European Life Science Law Update, our cross-practice team highlights key trends across life sciences regulatory, corporate, compliance, competition, and privacy throughout the EU, with special focus in this edition on the Big Five (France, Germany, Italy, Spain, UK). Among the competition updates, we outline how Portuguese competition authority accused COVID-19 laboratories of price-fixing and no-poaching arrangements. Make sure to subscribe to Engage for our quarterly updates on current and evolving European life sciences legal developments. (Authored by Joerg Schickert)
The U.S. Food and Drug Administration (FDA) proposed an annual June deadline for its COVID-19 vaccine strain selection, according to briefing documents posted ahead of its Thursday virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). This schedule would mean that vaccines can be rolled out every September. FDA is proposing a simplified approach to the COVID-19 immunization schedules so that certain young children, older adults and immunocompromised people would receive a two-dose primary schedule while all other individuals would receive a one-dose primary vaccine. The Committee, along with CBER Director Peter Marks, will discuss those proposals and will vote on a question about harmonizing primary regimens with booster shots. (Authored by Randy Prebula)
On Thursday, NIH will hold a virtual meeting of the Office of the Secretary to finalize the draft recommendations and findings from the National Science Advisory Board for Biosecurity (NSABB) working group entitled, “Potential Pandemic Pathogen Care and Oversight (PC3O) Policy and U.S. Government Policies for the Oversight of Dual Use Research of Concern.” Last week, U.S. Rep Brett Guthrie (R-KY2) introduced the Pandemic is Over Act, a bill to end the COVID-19 public health emergency (PHE). CMS announced plans to develop new guidance to lay out how the year-end spending deal will affect the optional Medicaid coverage of COVID-19 testing, vaccines, and treatments for uninsured, following Congress’ vote to decouple the Medicaid continuous coverage requirement from the public health emergency. Last week, the World Health Organization (WHO) updated its COVID-19 guidelines on treatments, isolation periods, and mask wearing; [regnant or breastfeeding women with non-severe COVID-19 should consult with their doctor to determine whether they should take the orally administered drug, WHO said. (Authored by Cybil Roehrenbeck)
German Federal Minister of Labor Hubertus Heil has announced that the Corona Occupational Health and Safety Ordinance may expire as early as 2 February 2023. The latest version of the Ordinance provides for an extensive test catalog for the risk assessment to be carried out to implement safety measures. The potential early expiration is said to be justified by the steady decline in the frequency and severity of infections with COVID-19 and the generally favorable forecasts regarding the medium- and long-term course of infections. Read more online here. (Authored by Dr. Lars Mohnke)
The U.S. National Institutes of Health (NIH) launched a virtual program aimed at making antiviral treatments for COVID-19 available at home for those who test positive: eMed, a privately-owned at-home health services firm, will host the official Home Test to Treat website, where individuals can sign up to receive antiviral treatment delivery as well as to coordinate telehealth-enabled test kits. An NIH study of children and adolescents who received a COVID-19 vaccination following multisystem inflammatory syndrome (MIS-C) found that there were no reports of serious complications including myocarditis or MIS-C reoccurrence. Last week, CDC issued a report on “Racial and Ethnic Differences in COVID-19 Vaccination Coverage Among Children and Adolescents Aged 5–17 Years and Parental Intent to Vaccinate Their Children — National Immunization Survey–Child COVID Module.” The U.S. published an order last week requiring negative pre-departure COVID–19 test results or documentation of recovery from COVID–19 for aircraft passengers traveling to the United States from the People’s Republic of China. We expect several the new (118th) U.S. Congress to further investigate the origins of COVID-19. (Authored by Cybil Roehrenbeck)
The U.S. Food and Drug Administration (FDA) updated the “SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests” web page to add DxTerity SARS-CoV-2 RT PCR CE Test as a test expected to have reduced performance for the SARS-CoV-2 Omicron Variant and Sub-Variants. FDA released important information about risk of COVID-19 due to certain variants not neutralized by Evusheld. The World Health Organization says the new coronavirus variant, XBB.1.5 “the most transmissible” descendant of omicron yet; XBB.1.5 rose from barely 2 percent of U.S. cases at the start of December to more than 27 percent in the first week of January. FDA has also withdrawn guidance on “Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID–19 Outbreak.” (Authored by Randy Prebula)
Last week, FDA approved a new indication for Roche/Genentech’s Actemra (tocilizumab) injection for the treatment of hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Also last week, FDA issued emergency use authorizations (EUAs) for 3 additional OTC at-home COVID-19 Tests: the ImmuView COVID-19 Antigen Home Test (manufactured by CTK Biotech, Inc.), the Advin COVID-19 Antigen Test @Home, and the ASSURE-100 Rapid COVID-19 Home Test (manufactured by Oceanit Foundry LLC). FDA will continue hosting the virtual town hall series on test development and validation during public health emergencies to provide information and answer questions about test development, with the next scheduled for January 11. The Omicron subvariant XBB has surged to more than 50% of COVID-19 cases in the northeastern U.S., according to the Centers for Disease Control and Prevention (CDC). (Authored by Randy Prebula)
U.S. Senate appropriators have unveiled the compromise text of the $1.66 trillion FY-23 spending omnibus package that Congress is rushing to pass in order to fund the government through September. The 4,155-page "Consolidated Appropriations Act, 2023" is also the last piece of must-pass legislation on the docket of the 117th Congress and includes many policy riders affecting a wide range of industries. U.S. President Joe Biden had asked for $9 billion to fight the COVID-19 pandemic and meet emerging needs, but Congress did not add to past funding legislation in the omnibus. Lawmakers earned savings for other health care provisions by including a bipartisan agreement to move up the conclusion of the COVID-era Medicaid policy by three months, concluding in April 2023 instead of July 2023. We have summarized the nearly-finalized $1.7 trillion omnibus spending proposal online here. (Authored by Aaron Cutler and Cybil Roehrenbeck)
Last week, the U.S. House and Senate Armed Services Committees released compromise text for the annual National Defense Authorization Act (NDAA), which includes a provision requiring the Defense Department to “rescind the mandate that members of the Armed Forces be vaccinated against COVID-19,” which the White House called a "mistake." The House passed the bill on Dec. 8 by a vote of 350 to 80; the Senate is expected to vote on the bill this week. Yesterday, the U.S. Veterans' Affairs Committee held a hearing on “Review of the Role of VA’s Fourth Mission and Pandemic Response.” Today, the Congressional Crisis Subcommittee will hold hearing on “Preparing for and Preventing the Next Public Health Emergency: Lessons Learned from the Coronavirus Crisis.” On Friday, the Select Committee on the Coronavirus Crisis released a report on “Preparing for and Preventing the Next Public Health Emergency; Lessons learned from the Coronavirus Crisis.” Last week, CDC Director Rochelle Walensky said in an interview with Roll Call that CDC has run out of creative ideas with its limited pandemic funds and needs more funding from Congress. (Authored by Cybil Roehrenbeck)
Last week, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age. On Monday, FDA updated the frequently asked questions about medical gloves during the COVID-19 public health emergency. Yesterday, FDA updated the “SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests” web page to add Luminostics, Inc. Clip COVID Rapid Antigen Test as a test expected to have reduced performance for the SARS-CoV-2 Omicron Variant and Sub-Variants. In a press release, FDA warned consumers to check COVID-19 at-home test expiration dates. Writing in the Journal of the American Medical Association on Friday, CBER Director Peter Marks said vaccine developers & government officials should consider an effort similar to Operation Warp Speed to develop the next generation of COVID-19 vaccines that protect against potential new variants. Also last week, FDA issued an EUA for the Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit. (Authored by Randy Prebula)
Among the many irreversible changes that the COVID-19 pandemic has brought to the labor market, one of the most important has been the increased flexibility as to where employees carry out their duties. The existing Polish regulations concerning teleworking, which have been in force since 2007, are no longer in line with the dynamically changing needs of companies and employees. The COVID-19 regulations dealing with home office (which was actually a single provision introduced by the Act of 2 March 2020) was, from the beginning, treated as a makeshift solution which has featured in the Polish legal order for an unexpectedly long time. After more than two years, we are now witnessing the legislative process on remote work being finalized. The upcoming amendment to the Labor Code requires employers to take specific action, first and foremost to establish the rules for remote working within its internal regulations with the involvement of staff representatives. We have analyzed the upcoming changes in Polish employment law online here. (Authored by Agnieszka Szczodra-Hajduk
Valerie Jensen, director of FDA’s drug shortage staff, said last week that FDA is preparing to help drug makers transition from emergency use authorization (EUA) to full approval for COVID-19 vaccines and other treatments, and that the agency will continue to focus on curbing ongoing drug shortages. On Monday, Pfizer/BioNTech said they have submitted an application to FDA for EUA of their Omicron-adapted COVID-19 vaccine booster for children aged 6 months through 4 years. CMS has released an update to the public use file that presents Medicare utilization and spending information for administration of the COVID-19 vaccine. Additionally, CMS released an update to the COVID-19 Hospitalization Trends Report last week that highlights trends in hospitalization rates in 2020, 2021, and the first half of 2022. (Authored by Randy Prebula)
U.S. House Select Intelligence Committee held a markup of H.Res.1466, which requests the President transmit certain documents to the House of Representatives relating to the investigation by the intelligence community into the origins of the COVID-19 virus. Later this week, HHS will hold a meeting of the National Advisory Council on Nurse Education and Practice on the nursing workforce, nursing practice improvement, nursing education, and the response to the COVID-19 pandemic. Sen. Mike Lee (R-UT) and Rep. Andy Biggs (R-AZ) introduced bills that would prohibit HHS from placing any vaccine for COVID-19 on the child and adolescent immunization schedule unless the Secretary provides clinical data relating to the safety and efficacy of the vaccine. Reps. Cathy McMorris Rodgers (R-WA), Brett Guthrie (R-KY), Morgan Griffith (R-VA) wrote a letter on Nov. 30 to Lawrence Tabak, Acting Director, urging NIH to provide information related to the origins of the COVID-19 pandemic, including matters related to NIAID grant to EcoHealth Alliance and subgrant to the Wuhan Institute of Virology. And yesterday, U.S. Trade Representative Katherine Tai said the U.S. wants to extend a 17 December deadline for waiving global IP protection for COVID-19 diagnostics and treatments, a move that some see as likely to impede the chances for a World Trade Organization agreement to strengthen international access to pandemic-related medical products. (Authored by Cybil Roehrenbeck)
Our new APAC Foreign Direct Investment (FDI) Legal Guide compares the Foreign Direct Investment (FDI) regimes in nine Asia-Pacific (APAC) jurisdictions, including: Australia, India, Indonesia, Japan, Mongolia, People’s Republic of China (Hong Kong and Mainland China), Singapore and Vietnam. A summary table of key features and detailed Q&A provide a road map to navigate FDI across these APAC jurisdictions. You can use this new guide to view and compare: types of deals subject to a FDI regime, principal authorities, lookback period, mandatory /voluntary filing, substantive test for intervention, extra-territorial reach, timeline for review, potential penalties, FDI clearance necessary to close, right to appeal, and special measures in response to COVID-19. (Authored by Charles Bogle)
This past week, the U.S. Food and Drug Administration (FDA) authorized four additional over-the-counter (OTC) at-home COVID-19 antigen tests: the Fastep COVID-19 Antigen Home Test (manufactured by Azure Biotech Inc.); the CorDx COVID-19 Ag Test; the Hotgen COVID-19 Antigen Home Test; and the NIDS COVID-19 Antigen Home Test (manufactured by ANP Technologies, Inc.). Yesterday, FDA also issued an Emergency Use Authorization (EUA) for the Lucira COVID-19 & Flu Test for use in a point-of-care setting. (Authored by Randy Prebula)
The Government Relations and Public Affairs group has released its 2022 Midterm Elections and 118th Congress Outlook report showing how the results have changed the political landscape of the U.S. House of Representatives and Senate. The incoming Republican majority in the House plans rigorous oversight on a variety of COVID -19 issues. The GOP may decide to dismantle the Select Subcommittee on the Coronavirus Crisis launched by Democrats in 2020 or change its purpose. If it is disbanded, the House Oversight Committee or a new Select Committee on China will investigate the origins of COVID-19, China's response, and supply chain issues for critical medical and personal protective equipment. Also, expect probes into the Biden administration's response to the virus, misuse of COVID funds, and allegations of government-funded gain of function research. House Republicans are unlikely to support future Biden administration funding requests for COVID response, causing people to turn to the private sector for testing, vaccinations, and treatment. The report provides an overview of the trends emerging from the norm-breaking election results, what to expect in the lame duck session, and the outlook for leadership and policy in the 118th Congress. (Authored by Aaron Cutler)
The UK Financial Conduct Authority (FCA) has published a report on firms' treatment of borrowers in financial difficulty following the COVID-19 pandemic. The FCA review has already led to significant remediation with around 60,000 customers already receiving compensation. All financial services firms need to consider their treatment of customers in financial difficulties with the spotlight, especially placed on lenders who need to ensure that their treatment of these customers results in good outcomes. Online here we have summarized the key findings of the report. (Authored by James Black)
Jointly with the Federal Trade Commission (FTC) last week, FDA issued a warning letter to Alternative Health Distribution LLC d/b/a CannaAid for selling unapproved and misbranded products for use in treating or preventing COVID-19, continuing the trend of FDA actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. FDA also updated the Health Care Provider Fact Sheet for bebtelovimab last week with specific information regarding expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2, showing that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. (Authored by Randy Prebula)
In the latest episode of our “A Perspective Podcast,” Andrew Skipper spoke to the Chief Executive Officer of the Nigerian Exchange Ltd, Temi Popoola. They discussed how NGX and other African exchanges are working to achieve their goals despite high levels of volatility in the global economy. They explore what aspects of COVID-19 have been the most challenging in the Nigerian capital markets space, as well as what it means to get Nigeria’s investment landscape “future-ready.”
The annual J.P. Morgan Healthcare Conference (JPM), Biotech Showcase, and ancillary meetings are back, live and in-person, in January 2023, providing a unique opportunity to make connections among life sciences and health care emerging companies, pharmas, investors, and advisors. Start-up biotech companies in particular need to use their time wisely to meet strategic partners and form relationships with the ultimate goal of raising capital. As companies are restarting after the COVID-19 pandemic wanes, we have outlined for you steps you can take now to help make the most of your JPM experience. Read more online here. (Authored by Kristin Connarn)
Last week, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. Also last week, the U.S. Department of Health and Human Services (HHS) formally renewed the federal COVID-19 public health emergency (PHE) for another 90 days. Yesterday, FDA issued an EUA for the first over-the-counter molecular test authorized for use with saliva specimens to Aptitude Medical Inc. for their Metrix COVID-19 Test: a single-use molecular in vitro diagnostic test for the detection of SARS-CoV-2. Also yesterday, U.S. President Biden signed the “National Biodefense Strategy”: three documents intended to prepare for the next pandemic after COVID-19. The plan said the U.S. must address the “accidental release of biological agents, and threats posed by terrorist groups or adversaries seeking to use biological weapons." Meanwhile, Jiangsu Well Biotech Co., Ltd. is recalling COVID-19 Ag Rapid Test Devices because they were distributed to U.S. customers without FDA authorization, which the agency identified as a Class I recall. (Authored by Randy Prebula)
Mexican federal authorities issued new national guidelines for the continuity of economic activities due to COVID-19, which establish specific measures that economic activities must implement in order to continue with labor activities in a secure and responsible way. These measures include: providing general information regarding COVID-19; washing hands frequently or using antibacterial gel; social distancing requirements; and establishing a training program for management personnel with actions and measures to prevent COVID-19 infection, among other measures. We have analyzed these new workplace guidelines online here. (Authored by Luis Ruiz Gutierrez)
The U.S. Centers for Disease Control and Prevention (CDC) said on Monday it had ended its COVID-19 country travel health notices as fewer countries reported enough data for accurate assessments. U.S. House Energy and Commerce Committee Republican Leader Cathy McMorris Rodgers (R-WA), Subcommittee on Health Republican Leader Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Republican Leader Morgan Griffith (R-VA) wrote a letter on 28 September to CDC Director Rochelle Walensky and NIH Acting Director Lawrence Tabak regarding biosafety and the safe handling and containment of infectious microorganisms and hazardous biological materials; this letter comes as Republicans on the committee continue to investigate the origins of COVID-19. The U.S. Supreme Court on Monday declined to hear a challenge by Missouri and nine other states - mostly Republican-led - to President Joe Biden's COVID-19 vaccine mandate for workers in health care facilities that receive federal funds. (Authored by Cybil Roehrenbeck)
The U.S. Food and Drug Administration (FDA) warned health care providers that COVID-19 drug Evusheld, which is made by AstraZeneca and FDA-authorized to prevent coronavirus infections in certain patients, is likely ineffective against strains of the Omicron variant, including BA.4/BA.5. Around two-thirds of adults in the U.S. do not plan to get updated COVID-19 booster shots soon, according to a survey conducted by the Kaiser Family Foundation (KFF), a health policy nonprofit organization. Last week, FDA issued jointly with the Federal Trade Commission (FTC) a warning letter to Bespoke Apothecary LLC for selling unapproved and misbranded COVID-19 kit and Post Virus Recovery Herbal Tea products as drugs for use in treating or preventing COVID-19. (Authored by Randy Prebula)
Yesterday, the U.S. Food and Drug Administration (FDA) announced it updated its COVID-19 test policy and moving forward, FDA will only review a “small subset” of emergency use authorization (EUA) requests for COVID-19 diagnostic tests. In final revised guidance entitled “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency,” FDA encouraged test developers to pursue authorization through the de novo classification or 510(k) clearance pre-market review pathways. The agency stated it will generally prioritize EUA reviews for: tests likely to have a significant benefit to public health or that will fulfill an unmet need; supplemental EUA requests for which the request will significantly benefit public health or fulfill an unmet need; and requests that come from or are supported by U.S. government stakeholders. However, EUA requests submitted prior to the release of the revised guidance will remain in the review queue. (Authored by Randy Prebula)
On Monday, Pfizer/BioNTech said they are asking FDA to authorize their Omicron-specific booster shots for children between ages 5 and 11. This news came a few days after Moderna filed an FDA application for its updated boosters, which the Centers for Disease Control and Prevention (CDC) said would be available for children aged 5-11 years old in mid-October. These applications represent a step towards getting children vaccinated by a so-called bivalent vaccine, which targets both the original strain of the virus and the circulating BA.4 and BA.5 subvariants of Omicron. (Authored by Randy Prebula)
The U.S. Congress must pass a stopgap spending bill this week to avoid a partial government shutdown late next week, and a White House supplemental request for additional COVID-related funding is still pending. Last week, the U.S. Senate passed the “Improving Medicare Patients with RNHCI Options to Vaccinate Easily Act” or the “IMPROVE Act” (S.4899): “A bill to amend Title 18 of the Social Security Act to Remedy election revocations relating to the administration of COVID-19 vaccines.” In an interview on “60 Minutes” on 19 September, U.S. President Joe Biden said that the coronavirus pandemic is over, in comments that seemed to contradict statements made by White House staff that fear a fall and winter wave of the virus, and as the Biden Administration has yet to lift the COVID-19 public health emergency (PHE). Last week, the CDC also updated its “Strategy for Global Response to COVID-19.” (Authored by Cybil Roehrenbeck)
Recent U.S. Department of Health Human Services (HHS) regulatory actions emphasize the role emerging technologies play in the provision of health care, particularly as clinical innovations proliferate in response to the COVID-19 pandemic. These actions include HHS guidance concerning the accessibility of telehealth services as well as proposed rules on nondiscrimination in clinical algorithms and telehealth services. We have summarized these recent actions online here. (Authored by Melissa Bianchi)
Last week, Rep. Anna Eshoo (D-CA) wrote a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure to ensure that at-home COVID-19 tests are covered for Medicare beneficiaries after the public health emergency (PHE) ends. HHS is expected to renew the PHE designation in October but then let it expire in January 2023. Also last week, the U.S. Centers for Disease Control and Prevention (CDC) published updated information on “Possible Side Effects After Getting a COVID-19 Vaccine.” Today, the U.S. Congressional Coronavirus Crisis Subcommittee will hold a hearing on “Examining Long-Term Care in America: The Impact of the Coronavirus in Nursing Homes.” CMS has released its Third Edition HQRP Public Reporting Tip Sheet, to help providers understand public reporting for the Hospice Quality Reporting Program in the midst of the PHE. Last, the White House has updated its COVID-19 Global Response and Recovery Framework. (Authored by Cybil Roehrenbeck)
In its Second Annual Report on the screening of foreign direct investment (FDI) into the Union, the EU Commission takes stock of the FDI screening rules at both EU and Member State level. Today, 25 out of 27 Member States either have a screening mechanism in place or are in the process of setting one up. Most of the existing FDI regimes have undergone changes in light of COVID-19 and recent disruptions in global supply chains, often upgrading screening procedures and expanding covered sectors. Statistics show that FDI screening is becoming more and more a crucial regulatory puzzle piece in M&A transactions. We have analyzed key insights from the latest EU FDI report online here. (Authored by Falk Schoening)
The U.S. Food and Drug Administration (FDA) said ACON Laboratories’ Flowflex COVID-19 Antigen Home Tests now have a longer shelf-life than previously authorized. On Monday, FDA reissued its letter of authorization for Novavax COVID-19 Vaccine, Adjuvanted to revise the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Novavax to include myocarditis and pericarditis. Last week, FDA had updated its web page on FAQs on Viral Transport Media During COVID-19. Also last week, the Biden Administration said the U.S. ordered over 100 million domestically manufactured home COVID-19 tests for the country's stockpile. (Authored by Randy Prebula)
U.S. President Biden is requesting $47.1 billion in emergency funding, which could face opposition from Republicans, as it includes $22.4 billion for COVID-19 and $4.5 billion for monkeypox, which they have rejected. Yesterday, HHS announced that people with Medicare, Medicaid, Children’s Health Insurance Program (CHIP) coverage, private insurance coverage, or no health coverage can get COVID-19 vaccines at no cost, for as long as the federal government continues purchasing and distributing these COVID-19 vaccines. The HHS OIG issued a report on “Medicare Telehealth Services During the First Year of the Pandemic: Program Integrity Risks”; and another report concluding that “Certain Medicare Beneficiaries, Such as Urban and Hispanic Beneficiaries, Were More Likely Than Others To Use Telehealth During the First Year of the COVID-19 Pandemic.” This Thursday, the U.S. House Foreign Affairs International Development, International Organizations and Global Corporate Social Impact Subcommittee will hold a hearing on “The Sustainable Development Goals and Recovery from the COVID-19 Pandemic: Implications for U.S. Policy.” (Authored by Cybil Roehrenbeck)
The U.S. Food and Drug Administration (FDA) recently issued draft guidance on how it will continue to conduct remote regulatory assessments (RRAs) after the COVID-19 public health emergency (PHE) ends. This guidance summarizes FDA’s plans to continue post-pandemic to use its records request authority and virtual inspection tools, in addition to the agency’s traditional on-site activities, to allow for more targeted facility inspections. Online here we have summarized FDA’s expectations around who will be subject to RRAs moving forward, what information FDA may request as part of an RRA, and the consequences for an establishment that declines an RRA. Key takeaways are that sponsors and manufacturers should ensure that inspection readiness plans consider records requests and interactive evaluations in coordination with on-site inspections, and address FDA’s expectations around technological capabilities for RRAs and remote reviews. (Authored by Jodi Scott)
Last month, the Dutch Minister of Health, Welfare and Sport published the long-awaited Policy Rule regarding Stocks of Medicinal Products (in Dutch: “Beleidsregel aanhouden geneesmiddelenvoorraden”). With a goal of ensuring medicinal supply interruptions are better managed, the Dutch Ministry’s Policy Rule regarding “iron stock” sets obligations for marketing authorization holders (MAHs) and wholesalers to keep a minimum safety stock of prescription-only medicinal products and provides guidance on how that stock is to be calculated. The European Medicines Agency (EMA) also published guidance in May with key principles and examples of good practices to support patients and healthcare professional organizations in preventing and managing shortages of human medicines. With the COVID-19 pandemic increasing the impact of medicine shortages, these policies intend to improve of pandemic preparedness in the Netherlands. We have analyzed the Policy Rule and EMA guidance online here. (Authored by Hein van den Bos)
Next-gen COVID-19 vaccines that offer protection against multiple variants will likely be available in the U.S. within the next few weeks, White House COVID-19 response coordinator Ashish Jha said yesterday, adding that they would ideally be offered to all adults, but also that supplies are limited due to lack of congressional funding. Novavax said Monday it had filed for U.S. authorization for use of its COVID-19 vaccine as a booster dose in people who had either received its shots or a different vaccine. Last week, FDA issued a safety communication on the risk of false negative results in at-home COVID-19 antigen tests, advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test. It seems likely HHS will extend the COVID-19 public health emergency (PHE) beyond October (into January) after last week passed without HHS releasing the 60 days’ notice that is expected to signal the upcoming end of the PHE. (Authored by Randy Prebula)
The U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a requirement that manufacturers of class I devices submit UDI information for these products to the Global Unique Device Identification Database (GUDID) until 8 December 2022. This represents an enforcement discretion period of 75 additional days for submission to the GUDID, though no extension was provided for other elements of UDI compliance. The guidance further exempts a new category of class I devices termed “consumer health products” from GUDID submission requirements and provides relief for direct marking other devices which were manufactured prior to applicable compliance dates and may still remain in inventory. The compliance deadlines for manufacturers of most class I devices have been pushed back several times due to the COVID-19 pandemic and other concerns, including policy and technical issues. Read more online here. (Authored by Lina Kontos)
The U.S. Health and Human Services Department (HHS) released two new reports on Long COVID to support patients and further research. According to the press release, the “National Research Action Plan on Long COVID” details advances in current research and charts a course for future study to better understand prevention and treatment of Long COVID. The “Services and Supports for Longer-Term Impacts of COVID-19” report highlights resources for health care workers, and those effected by broader effects of COVID-19, including not only Long COVID but also effects on mental health and substance use, and loss of caregivers and loved ones. The CDC and the Task Force for Global Health held the 11th International Conference on Emerging Infectious Disease this week. HRSA is holding a meeting of the National Advisory Council on Nurse Education and Practice on the nursing workforce, nursing practice improvement, nursing education, and the response to the COVID-19 pandemic this week. (Authored by Cybil Roehrenbeck)
Last week, FDA issued a warning letter to FluxxLab LLC for selling unapproved and misbranded tincture products as drugs for use in treating or preventing COVID-19. FDA has observed that their website offers the COVID-19 Immune Support Tincture and the CBDA+CBD Oil Tincture products for sale in the United States and that FluxxLab claims these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. FDA has been taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19. (Authored by Randy Prebula)
The U.S. Food and Drug Administration (FDA) announced Friday that the Biden Administration plans to launch its fall COVID-19 booster campaign next month, earlier than expected, using updated booster formulations targeting the Omicron BA.4 and BA.5 subvariants. FDA also reportedly decided against offering a second booster dose of existing COVID-19 vaccines to Americans younger than 50 after receiving assurances from Moderna and partners Pfizer/BioNTech that they can deliver the updated boosters next month. The U.S. said it will pay $1.74 billion for 66 million doses of Moderna's COVID-19 vaccine designed to protect against Omicron subvariants. Those doses will be delivered this year and follow last month's announcement that the government would buy 105 million doses of Pfizer/BioNTech's COVID-19 vaccines. FDA extended the expiration date for the MaximBio ClearDetect COVID-19 Antigen Home Tests, which are FDA authorized under emergency use authorization now have an 8-month shelf-life. And last, the agency has reauthorized Meridian Bioscience's EUA for the Revogene COVID-19 molecular diagnostic assay, initially granted in November 2021. (Authored by Randy Prebula)
U.S. Sens. Patrick Leahy (D-VT), Patty Murray (D-WA), and Chris Coons (D-DE) introduced a $21 billion emergency supplemental appropriations bill to address the ongoing COVID-19 crisis and other emerging diseases. U.S. Rep. Carol Miller (R-WV) introduced H.R. 8505, legislation that would permanently allow the continuation of hospice recertification via telehealth since being included in the "Coronavirus Aid, Relief, and Economic Security (CARES) Act”; a two-year extension of this virtual hospice provision was also included in H.R. 4040, the “Advancing Telehealth Beyond COVID–19 Act of 2021,” which passed the House 416 to 12. In the Senate Foreign Ops appropriations bill, Democrats are proposing nearly $6 billion in additional emergency COVID-19-related foreign aid spending on top of a baseline fiscal year funding level for diplomacy and development that closely matches what House Democrats have put forth. The Senate Small Business and Entrepreneurship Committee held a hearing on “Oversight of SBA’s COVID Economic Injury Disaster Loan Program.” The Senate Homeland Security and Governmental Affairs Emerging Threats and Spending Oversight Subcommittee held a hearing on “Revisiting Gain of Function Research: What the Pandemic Taught Us and Where Do We Go From Here.” (Authored by Cybil Roehrenbeck)
The newly proposed Regulation on Substances of Human Origin (“SoHO Regulation”) will give a new shape to the EU legal framework on human blood, tissues, and cells. After almost 20 years in place, the EU legislation in this sector was no longer meeting the scientific and technical state of the art and needed to be updated in face of current challenges, including those evidenced by the COVID-19 pandemic. Online here we have analyzed the objectives of the new SoHO Regulation, its impact on Advanced Therapy Medicinal Products (“ATMPs”) and medical devices, and its transitional provisions. The proposal is open for feedback until 8 September 2022. (Authored by Fabien Roy)
Yesterday, the U.S. House Rules Committee considered advancing a telehealth bill sponsored by Rep. Liz Cheney (H.R 4040) that would temporarily extend some Medicare payment rules that were allowed during the COVID-19 public health emergency (PHE), such as waiver of the so-called “originating site requirements,” audio-only telehealth, and an expanded list of telehealth practitioners, through 2024. A group of Republican senators opposed permanently extending pandemic-era health subsidies after a report by the Congressional Budget Office (CBO) and the Joint Committee on Taxation projected that the extension would increase the federal debt by $248 billion over the next decade. FEMA held a closed meeting to Implement the Pandemic Response Voluntary Agreement Under Section 708 of the Defense Production Act. HHS Secretary Xavier Becerra issued a statement last week recommending to make the Novavax vaccine more available to the American people. (Authored by Cybil Roehrenbeck)
The U.S. Food and Drug Administration released draft guidance on the expanded use of remote regulatory assessments (RRAs) and on how FDA generally intends this tool [once finalized] to be incorporated consistently across all FDA-regulated products beyond the current COVID-19 public health emergency; a separate Hogan Lovells analysis summarizing this guidance is forthcoming. Also last week, FDA authorized extended expiration dates for lots of Paxlovid to reflect the 12-month product shelf-life, when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 105 for Paxlovid. Meanwhile, the White House gathered federal officials, scientists, and pharmaceutical executives for a summit yesterday to discuss the next generation of COVID-19 vaccines, and to chart a path for developing them. (Authored by Randy Prebula)
The U.S. Department of Health & Human Services (HHS) extended the COVID-19 Public Health Emergency (PHE) on Friday for an additional 90 days, allowing waivers to continue for telehealth and other regulatory issues. A new CDC report found that the COVID-19 pandemic made the threat of antimicrobial-resistant infections worse, pushing back years of progress on the issue. Hospital-onset infections and deaths both increased by at least 15 percent during the pandemic's first year. The Biden Administration is warning Americans to take the latest COVID-19 variant, BA.5, more seriously, but their stated strategy, released Tuesday, is to keep doing more of the same — encouraging masking, testing, and getting vaccinated against COVID-19 when applicable. The BA.5 omicron subvariant, which is now the most prevalent coronavirus strain in the US, is four times more resistant to COVID-19 vaccines, according to a new study. (Authored by Cybil Roehrenbeck)
On 13 July, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. Yesterday, FDA updated the device shortage list and the device discontinuance list on the web page for Medical Device Shortages During the COVID-19 Public Health Emergency, providing information about devices that have been removed from the device shortage list at this time. Last week, the agency updated the SARS-CoV-2 Viral Mutations: Impact on and COVID-19 Tests web page to include information about genotyping tests authorized for the identification and differentiation of specific SARS-CoV-2 mutations, lineages or variants. American Contract Systems (ACS) is recalling the COVID Test Kit Nonsterile and Clean Catch Urine Kit products because they were assembled in an uncontrolled facility by people without proper training. (Authored by Randy Prebula)
The UK Department of Health and Social Care has released its new Strategy for the use of health and social care data in the UK (Data saves lives: reshaping health and social care with data), which should be read in conjunction with the UK government's proposals for health and care integration and the Standards and Interoperability Draft Strategy. The UK also published a National AI Strategy last year which contains ambitious plans in terms of investment in, and regulation of, AI across all sectors, including health and social care. A large focus of the Strategy is to digitize the health and social care records across the UK to drive greater efficiency in the NHS's service which will increase efficiencies and tackle the backlog of care that has built up due to COVID-19. We have analyzed the UK’s new health data strategy online here. (Authored by Nicola Fulford)
For the first time ever, the EU Commission has issued a decision on the relationship between EU merger control law and Hungary’s national FDI screening rules. It found that the Hungarian Government's veto of Vienna Insurance Group's planned acquisition of the Hungarian subsidiaries of Dutch insurer AEGON on the basis of Hungarian FDI screening rules violated the Commission's exclusive competence to assess concentrations with an EU dimension. Currently, there are two FDI screening mechanisms in Hungary, with a "temporary" FDI screening regime was introduced by the Hungarian Government in April 2020 with the aim of protecting Hungarian companies active in the relevant strategic industries in the context of the COVID-19 pandemic. Online here we explain the aspects of the deal that make it exceptionally noteworthy for international companies. (Authored by Dr. Falk Schoening)
The U.S. Food and Drug Administration (FDA) authorized the Genabio COVID-19 Rapid Self-Test and Watmind Speedy Swab Rapid COVID-19 Antigen Self-Test, which are over-the-counter (OTC) at-home COVID-19 antigen tests that shows results in 15 minutes. Last week, FDA approved Pfizer-BioNTech’s COVID-19 Vaccine COMIRNATY in individuals 12 through 15 years of age. The mRNA vaccine has been FDA-approved for use in individuals 16 years of age and older since August 2021. (Authored by Randy Prebula)
A National Institutes of Health (NIH) study describes the immune response triggered by COVID-19 infection that damages the brain’s blood vessels and may lead to short- and long-term neurological symptoms. Consistent with an earlier study from the group, SARS-CoV-2 was not detected in the patients’ brains, suggesting the virus was not infecting the brain directly. The U.S. House of Representatives Veterans Affairs Economic Opportunity Subcommittee held a field hearing on “Ending Veteran Hunger: Examining the Impact of COVID-19 on Food Insecurity.” (Authored by Cybil Roehrenbeck)
The state of epidemic for COVID-19 in Poland was lifted and replaced by the state of epidemic emergency. Special regulations of a substantive and procedural nature related to the epidemiological situation were introduced during the period of this epidemic state. An analysis of these provisions shows that a number of them only apply up until a particular time after the epidemic state has been revoked, whereas others apply until the complete revocation of the state of epidemic emergency. This distinction can be very important in terms of the proper application of the regulations and the fulfilment of tax obligations. Online here we have analyzed how lifting the state of epidemic in Poland is affecting economic entities. (Authored by Andrzej Debiec)
Yesterday, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. This followed FDA’s Monday authorization of an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together (REGEN-COV). FDA also held a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) yesterday to discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified; FDA advisers voted 19-2 in favor of updating coronavirus vaccines by Pfizer and Moderna to improve efficacy against the omicron strain, though they did not specify which substrain of omicron the vaccines should target. (Authored by Randy Prebula)
Last week, the U.S. Government Accountability Office (GAO) issued a report on “Pandemic Lessons Highlight Need for Public Health Situational Awareness Network.” Also last week, HHS published a report on “Office of Refugee Resettlement's Influx Care Facility and Emergency Intake Sites Did Not Adequately Safeguard Unaccompanied Children From COVID-19.” Meanwhile, the U.S. Centers for Disease Control and Prevention (CDC) announced it is rescinding the “Requirement for Negative Pre-Departure COVID-19 Test Result or Documentation of Recovery from COVID-19 for All Airline or Other Aircraft Passengers Arriving Into the United States From Any Foreign Country.” (Authored by Cybil Roehrenbeck)
Last week, the U.S. Food and Drug Administration (FDA) authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age. For the Moderna COVID-19 Vaccine, FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older. For the Pfizer-BioNTech COVID-19 Vaccine, FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older. In total, as of Friday, 438 tests and sample collection devices are authorized by the FDA under EUAs. (Authored by Randy Prebula)
Speaking Tuesday at the Food and Drug Law Institute (FDLI) Annual Conference, Mark Raza, FDA Chief Counsel, discussed the investigations priorities for FDA’s Office of the Chief Counsel (OCC), including its focus on stopping stem cell clinics that put patients at risk. Recent court rulings in favor of the agency, including the Eleventh Circuit affirming the lower court’s decision in US Stem Cell Clinic that the unproven stem cell therapy is subject to FDA regulation, likely will lead to increased enforcement action against unapproved stem cell therapies. While cell-based regenerative medicine has the potential for significant public health benefits, FDA has made clear that the agency “cannot allow unproven products that exploit the hope of patients and their loved ones.” This summer and beyond, we expect stepped up enforcement actions by FDA against parties marketing unapproved stem cell products, especially as FDA returns to full operational capacity and barriers to inspections arising from the COVID-19 pandemic wane. Read more online here. (Authored by Lowell Zeta)
During the last decade, the shape and source of capital flows and investment have fundamentally shifted. Private capital continues to flow into all asset classes including real estate, infrastructure, private credit, and private equity. The COVID-19 pandemic has most recently brought both challenges and opportunities for private capital investors. To minimize the risk and optimize the return on investments, efficient structuring of carried interest schemes has become more important than ever. With high amounts of money at stake and a coming global economic recovery, fund managers will want to receive their carried interest and co-investment returns in the most tax effective way - whether structured as classic carried-interest, ratcheted carry, hybrid carry, diverted carry, multi-waterfall carry, super carry or as a single performance-based fee. Take a look at our carried interest for fund managers toolkit, which highlights the main tax structuring products available for carried interest payments to fund managers in the major fund jurisdictions - France, Germany, Luxembourg, the Netherlands, Spain, the UK, and the U.S. (Authored by Cristina Arumi)
On Friday, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Laboratory Corporation of America (Labcorp) VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system, which is the first COVID-19 test authorized for the identification and differentiation of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages. Yesterday, FDA held a meeting of the Vaccines and Related Biological Products Advisory Committee to discuss requests to amend the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of a primary series to infants, children, and adolescents 6 months through 17 years of age, and to amend the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of a primary series to infants and children 6 months through 4 years of age; an FDA report showed the Pfizer vaccine as safe and effective for children younger than five, and FDA also said the Moderna shot is safe and effective for infants and young children. Separately, an FDA Independent Vaccine Advisory Committee voted to recommend that regulators authorize the Novavax's Covid-19 vaccine for emergency use in adults. Also last week, Moderna reported that its Omicron-specific mRNA booster shot produced a robust immune response against the variant. Meanwhile, Sanofi and GSK said their experimental booster vaccine delivers a more powerful immune response against coronavirus variants than their competitors’. (Authored by Randy Prebula)
Telehealth providers should prepare to comply with the HIPAA health privacy law once the federal public health emergency (PHE) ends, HHS said in a guidance Monday. The Senate HELP Committee will hold a hearing tomorrow on “An Update on the Ongoing Federal Response to COVID-19: Current Status and Future Planning.” A 9 June letter to Senate Minority Leader Chuck Schumer (D-NY) called for a permanent extension of COVID-19 era Affordable Care Act Tax Credit (APTC) that made health insurance more affordable for millions of Americans during the pandemic. The U.S. threw out 82.1 million COVID vaccine doses from Dec. 2020 through mid-May; vaccine providers say declining demand, large minimum orders, and multidose vials make it hard to avoid waste while still offering shots to anyone who wants them. Last week, the Biden Administration released details of its COVID-19 vaccination plan for children under 5, the last age group in the country without access to the vaccine. The World Trade Organization (WTO) is holding a long-delayed ministerial conference to craft a response to the pandemic, but the issue generating the most debate is a highly controversial proposal to temporarily waive IP rights for vaccines. (Authored by Cybil Roehrenbeck)
Germany is one of the most important and developed health care markets in the world. Legal developments are complex and often connected, whether in the areas of advanced therapies, digital health solutions, supply chain management, licensing transactions/collaborations/M&A, or COVID-19. Hogan Lovells Partners Andreas von Falck, Martin Pflüger, Jörg Schickert, and Matthias Schweiger share their insights on the trends and developments for the German market in the latest Chambers Life Sciences 2022 guide.
The U.S. Food and Drug Administration (FDA) held a virtual meeting yesterday of the Vaccines and Related Biological Products Advisory Committee to discuss an Emergency Use Authorization (EUA) request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older. FDA concluded that the Novavax vaccine was about 90% effective at preventing mild, moderate, and severe COVID-19 when tested in a study involving about 30,000 volunteers ages 18 and older. Yesterday, FDA published a notice of withdrawal of its Q&A guidance on “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices,” effective 7 July. Last week, Pfizer/BioNTech asked FDA to authorize three doses of their vaccine for children under 5. On Friday, FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19 online here. Also last week, FDA said in a blog post that it now has the staff it needs to review pre-submissions for devices that aren’t related to the pandemic. (Authored by Randy Prebula)
Last week, U.S. Reps. Jason Smith (R-MO), Jim Jordan (R-OH), Blaine Luetkemeyer (R-MO), and Kevin Brady (R-TX) wrote a letter to U.S. Attorney General Merrick Garland asking to be updated about reports of COVID-19 related fraud and what actions Associate Deputy Attorney General Kevin Chambers, who is to serve as Director for COVID-19 Fraud Enforcement, is planning to take. On 31 May, the Government Accountability Office (GAO) issued a report regarding private health insurance, headlined: “Limited Data Hinders Understanding of Short-Term Plans' Role and Value During the COVID-19 Pandemic.” The Centers for Medicare & Medicaid Services (CMS) released an updated public use file (PUF) that presents a preliminary, high-level overview of Medicare utilization and spending information from Medicare FFS claims related to the administration of COVID-19 vaccines. (Authored by Cybil Roehrenbeck)
NIH has awarded approximately $577 million to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern; the AViDD centers will conduct innovative, multidisciplinary research to develop candidate COVID-19 antivirals, especially those that can be taken in an outpatient setting, as well as antivirals targeting specific viral families with a high potential to cause a pandemic in the future. An NIH-supported research team has identified characteristics of people with long COVID and those likely to have it. On 19 May, CDC recommended that children ages 5 to 11 should receive Pfizer COVID-19 booster shots; the vote tally was 11-1 with one abstention. The Biden Administration announced that Americans can order additional free at-home, rapid tests at COVIDTests.gov. The HHS Office of the Assistant Secretary for Preparedness & Response released an update on COVID-19 Therapeutics Distribution. (Authored by Cybil Roehrenbeck)
FDA’s vaccine advisers are expected to meet June 15 to discuss Pfizer’s and Moderna’s COVID-19 vaccines for kids ages 6 months to 4 years and 6 months to 5 years, respectively, FDA announced Monday. Last week, FDA published the refreshed Know Your Treatment Options for COVID-19 Consumer Update with the latest information on COVID therapies. The FDA has approved two drug treatments for COVID-19 and has authorized others for emergency use during this public health emergency. (Authored by Randy Prebula)
On Monday, the U.S. Food and Drug Administration (FDA) authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription by individuals with symptoms of respiratory viral infection consistent with COVID-19. This product is the first direct-to-consumer (DTC, non-prescription) multi-analyte COVID-19 test authorized by FDA, and the test can identify and differentiate multiple respiratory viruses at the same time, detecting influenza A and B, commonly known as the flu, respiratory syncytial virus, commonly known as RSV, along with SARS-CoV-2. Yesterday, FDA had amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the vaccine. (Authored by Randy Prebula)
The U.S. Department of Health & Human Services (HHS) will extend the COVID-19 public health emergency (PHE) past July, a person familiar with the matter told Bloomberg. The U.S. House Oversight and Reform Subcommittee on the Coronavirus Crisis held a hearing on “Underpaid, Overworked, and Underappreciated: How the Pandemic Economy Disproportionately Harmed Low-Wage Women Workers.” At the second Global COVID-19 Summit last week, U.S. President Biden announced that NIH has licensed 11 COVID-19 research tools and early-stage vaccine and diagnostic candidates to the Medicines Patent Pool (MPP) through the World Health Organization’s COVID-19 Technology Access Pool (C-TAP). The licenses will allow manufacturers from all around the world to work with MPP and C-TAP to use these technologies for the potential development of COVID-19 vaccines, treatments, and diagnostics to benefit people living in low- and middle-income countries. The White House released a fact sheet about the 2nd Global COVID-19 Summit; additional new commitments including more funding for pandemic preparedness at the World Bank. (Authored by Cybil Roehrenbeck)
The COVID-19 pandemic remains a dominant theme in our forward looking view for companies in the life sciences and health care industry, as the past year has continued to create challenges and a seemingly endless stream of lockdowns and viral surges. While uncertainties abound, we remain hopeful that the innovations necessitated by our collective pivot to pandemic life will become a part of our new normal. Our annual Life Sciences and Health Care Horizons publication identifies a number of evolving trends such as precision medicine, AI, virtual health solutions, advanced analytics, and related cybersecurity measures that are shaping the future of the industry. With perspectives from around the world in Asia-Pacific, Europe, Latin America, and the U.S., its provides creative strategies for your most promising opportunities and integrated solutions that protect and support your business when issues arise. (Authored by Lynn Mehler)
Germany is one of the most important and developed healthcare markets in the world. Legal developments are complex and often connected, whether in the areas of advanced therapies, digital health solutions, supply chain management, licensing transactions/collaborations/M&A, or COVID-19, to name a few. Read the full chapter on trends and developments in the German market in the Chambers Life Sciences 2022 Guide online here. (Authored by Andreas von Falck)
FDA News: Yesterday, the U.S. Food and Drug Administration (FDA) approved a new indication for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). FDA also said last week it is limiting the use of certain COVID-19 vaccines, citing findings of potential rare side effects. FDA published revised guidance on “Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions” during the COVID-19 Public Health Emergency (PHE). CBER Director Peter Marks recently told lawmakers that FDA might accept less than 50% efficacy for COVID-19 vaccines for kids, especially if the vaccines mirror the efficacy for adult vaccines, as the agency faces pressure to authorize a vaccine for children under the age of 5. Sen. James Clyburn (D-SC) said FDA is willing to move up the tentatively held meeting dates of its independent vaccine advisory panel should agency reviewers complete their analyses of data on pediatric COVID-19 vaccines more quickly than expected. (Authored by Randy Prebula)
Other U.S. News: The Biden Administration’s concerns about a coming COVID-19 wave continue, as do funding requests for vaccine administration and other measures, and President Biden is planning his second global vaccine summit, which Press Secretary Jen Psaki said will highlight that "our job is not done." The CDC released updated mask guidance recommending that everyone aged 2 and older wear a mask or respirator in indoor areas of public transportation and transportation hubs. The Senate Appropriations Subcommittee on State, Foreign Operations, and Related Programs will hold a hearing today on the global food security and COVID-19 crises. FEMA will also hold a meeting today under the Pandemic Response Voluntary Agreement under Section 708 of the Defense Production Act to establish a national strategy for the coordination of national multimodal health care supply chains to respond to COVID-19. U.S. Senators wrote a letter to CMS Administrator Chiquita Brooks-LaSure supporting CMS’s efforts to empower pharmacists to serve as Medicare providers “to increase access to testing and get shots in arms.” Also last week, other Congressmen wrote to companies contracting with states to assist in determining who is eligible for Medicaid and Children’s Health Insurance Program (CHIP) coverage at the end of the COVID-19 PHE. (Authored by Cybil Roehrenbeck)
The U.S. Food and Drug Administration (FDA) announced plans to hold meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers, including meetings regarding vaccines manufactured by Novavax, Pfizer-BioNTech, Moderna, and one meeting on whether the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified. On Thursday, Moderna became the first vaccine maker to ask the FDA to authorize a COVID-19 shot for kids under age 6; Pfizer is expected to also soon submit an emergency use application for its vaccine for young children. On Friday, FDA warned there are counterfeit versions of the Flowflex COVID-19 Test Kits and iHealth COVID-19 Antigen Rapid Test Kits, which are at-home over-the-counter (OTC) COVID-19 diagnostic tests. FDA also updated its At-Home COVID-19 Diagnostic Tests FAQ to include expiration date information to help consumers find the current expiration date for any FDA authorized at-home OTC COVID-19 diagnostic test. Also last week, FDA updated the Digital Health Policies and Public Health Solutions for COVID-19 web page to include the FDA’s current policies that may support public health innovation in COVID-19-related digital health technologies and the response to COVID-19. Meanwhile, Celltrion is recalling certain Point of Care (POC) DiaTrust COVID-19 Ag Rapid Tests because they may have been distributed to unauthorized users. (Authored by Randy Prebula)
Lawmakers questioned HHS Secretary Xavier Becerra about the apparent end of the COVID-19 pandemic, noting at a hearing last week that more than two years of addressing COVID-19 have added to public mistrust of health officials. Secretary Becerra was also asked to explain what Republicans consider an inconsistency in the Administration’s domestic pandemic policy and its treatment of migrants on the southwestern border. The panel’s Democratic chairwoman, addressing the FY-2023 HHS budget that Becerra was there to justify, expressed concern about the use of health research appropriations. Meanwhile, the White House and House Democrats' plan to link a $33 billion aid package for Ukraine to a COVID-19 supplemental funding bill is receiving bipartisan opposition. HRSA held a meeting today and tomorrow of the National Advisory Council on Nurse Education and Practice on the nursing workforce, nursing practice improvement, nursing education, and the response to the COVID-19 pandemic. U.S. Reps. Cynthia Axne (D-IA) and Richard Hudson (R-NC) introduced the “Telehealth Extension and Evaluation Act,” which aims to ensure key telehealth services offered during the COVID-19 pandemic will continue for two years after the end of the COVID-19 public health emergency. A new CDC study shows that most Americans have already had COVID-19. (Authored by Cybil Roehrenbeck)
On 9 September 2021, a panel of experts convened to discuss the use of immunoglobulin (Ig) therapies, detail the therapeutic benefits of Ig therapies for various disease states, offer practitioner insights on the impact of the COVID-19 global pandemic on patient treatment, and discuss how policies can play a role in optimal patient treatment with Ig therapies. Online here, we have summarized key takeaways emerged from the presentation and the subsequent roundtable conversation among clinicians. You can view the full report here. (Authored by Stuart Langbein)
Over the past decade, China’s life sciences and health care sector has experienced unprecedented growth. China presents real opportunities for life sciences and health care companies, but knowing the evolving laws, regulations, rules and relevant guidance, and being able to navigate them successfully, require deep insights and experience. Hogan Lovells’ APAC life sciences and health care lawyers will host a series of webinars throughout 2022 that will look at the trends and challenges that companies in the life sciences and health care industry may be facing when planning or conducting business in Greater China. Partly in response to feedback from our clients, the series will feature informative presentations, cutting-edge analysis and engaging discussions, covering topics including in-country and cross-border handling and transfer of human generic resources and other personal data, cross-border license transactions, pandemic related issues, and key intellectual property issues such as patent linkage and patent term extension. We are delighted to invite you to the inaugural session of our APAC life sciences and health care webinar series on Tuesday, 17 May 2022, for which you can register online here. (Authored by Dr. Frederick Ch'en)
The COVID-19 crisis called for governmental responses of unprecedented scale, scope, and speed. Flexible regulatory approaches emerged by necessity to allow FDA and USDA to respond to the public’s need for access to food, personal protective equipment, and other critical items. Designated “critical infrastructure sectors,” key industries required decisive shifts in how these agencies traditionally go about the business of regulation to protect public welfare during the evolving pandemic. Viewing agency actions through the lens of the food industry, our latest article in the Food and Drug Law Journal analyzes the key regulatory flexibility strategies used by FDA and USDA (in conjunction with CDC and other agencies), identifies key learnings from how those strategies worked in the initial phase of the COVID-19 crisis, and explores ways for regulatory agencies to build on those processes, both for future crisis response and day-to-day regulatory activities. (Authored by Brian D. Eyink and Elizabeth B. Fawell)
On Monday, the U.S. Food and Drug Administration (FDA) expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, making Veklury the first approved COVID-19 treatment for children less than 12 years of age. Biden Administration chief medical adviser Anthony Fauci said FDA may wait until June to consider authorizing COVID-19 vaccines for kids under 5, though officials want to make Pfizer’s and Moderna’s products available simultaneously to minimize confusion. (Authored by Randy Prebula)
In an article published last week, BioSpace explained how life sciences firms will need to revert to normal operations post-pandemic, including adherence to the antitrust regulations that were waived during the public health emergency (PHE). The actual end of the pandemic and its legal end are different, Philip Katz, partner in the pharmaceuticals & biotechnology regulatory practice at Hogan Lovells, told BioSpace. Katz forecast that FDA will not be in a hurry to declare an end to the PHE justifying emergency use authorizations (EUAs); but nevertheless, the end of the PHE will affect FDA’s ability to be lenient regarding the extension of product expiration dates, deviations in good manufacturing practices, and allowing prescription products to be dispensed without individualized prescriptions. Katz explained how in the future, “There’s going to be a difficult public discussion about when we start treating COVID-19 like the flu.” You can read more of Katz’s insights online here.
Sponsors of clinical trials in the U.S. have a regulatory responsibility to monitor the progress of clinical studies. Historically, Sponsors performed in-person monitoring visits of every clinical trial site participating in the study. The COVID-19 pandemic made in-person monitoring impossible and pushed remote monitoring to the forefront. In March 2021, FDA published the guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” which suggests the use of “central and remote monitoring programs to maintain oversight of clinical trials” if on-site monitoring is not possible. Remote monitoring has proven to be a useful and cost-effective tool during the COVID-19 pandemic and it will likely continue to be used by Sponsors and CROs for monitoring clinical studies. However, it is not always easy to obtain remote access to a clinical site’s electronic health records. Hospitals are subject to various state and federal privacy laws, which impose privacy and security obligations on health information. We have analyzed the key issues related to remote monitoring terms in Clinical Trial Agreements online here. (Authored by Elizabeth McGuire)
Following a two-week recess, Congressional lawmakers returned to Washington, DC to consider FY-2023 appropriations and additional COVID-19 funding. The Democratic majority may attempt to tie the COVID-19 relief bill to the legislation that would provide additional support for Ukraine, raising its prospects for additional consideration. On Friday, the House Oversight & Reform Coronavirus Crisis Subcommittee will hold a hearing on "Ensuring Scientific Integrity at Our Nation's Public Health Agencies." Today, FEMA will hold a meeting under the Pandemic Response Voluntary Agreement Under Section 708 of the Defense Production Act to establish a national strategy for the coordination of national multimodal health care supply chains to respond to COVID-19. The Biden Administration announced a series of initiatives aimed at increasing the use of antiviral pills to treat COVID-19. Sens. Sheldon Whitehouse (D-RI) and Ed Markey (D-MA) are pressing the NIH to respond about the slow pace of research into “long COVID,” or “Post-Acute Sequelae of SARS-CoV-2 infection.” (Authored by Cybil Roehrenbeck)
In the latest edition of our securities, shareholder, and M&A litigation outlook for 2022, we analyze key developments from 2021 and discuss how the most important cases from Delaware may impact companies now and in the year to come. Among the themes observed in Delaware courts, which we expect to continue in 2022, is courts addressing the continued impact of COVID-19, issuing two significant decisions on COVID-19 and M&A transactions. (Authored by Ryan M. Philp)
The U.S. Secretary of Health and Human Services (HHS) has renewed its determination that a public health emergency exists in light of the continued consequences of the COVID-19 pandemic. The determination has been in place since 31 January 2020, and was set to expire on 16 April 2022. Temporary flexibilities and enforcement discretion put in place by the Food and Drug Administration (FDA) in response to this determination are expected to remain in effect for the duration of the public health emergency. Read more about this online here. (Authored by Elizabeth Fawell)
FDA issued an emergency use authorization (EUA) to InspectIR Systems for their InspectIR COVID-19 Breathalyzer test, which is the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection. In March, FDA had amended the Moderna COVID-19 vaccine EUA, and now the Centers for Medicare and Medicaid Services (CMS) has issued new codes for the Modern vaccine booster and administration, available online here. (Authored by Randy Prebula)
The U.S. House recently passed a $10 billion COVID-19 relief bill, but the Senate adjourned without passing the measure. Senate Republicans are objecting to the supplemental that would provide more therapeutics, vaccines, and testing supplies and by trying to push through an amendment that would prevent the Biden administration from ending Title 42, which is a federal health order limiting border crossings during public health emergencies. Outgoing White House COVID-19 Response Coordinator Jeff Zients released a statement calling on Congress to pass funds when it returns next week, saying, "The virus is not waiting on Congress to negotiate." (Authored by Cybil Roehrenbeck)
The COVID-19 pandemic revealed many potential supply chain shortages in the United States, and in response, the U.S. Department of Defense (DOD) has issued its long-awaited report in response to last year’s Executive Order 14017, Securing America’s Supply Chains, which called for a comprehensive review of supply chains in critical sectors, including the defense industrial base (DIB). The report, titled “Securing Defense-Critical Supply Chains,” assesses supply chains in the DIB and sets out DOD’s plan to align its priorities and capabilities to strengthen the industrial base and to establish a network of domestic and allied supply chains to meet national security needs. We have analyzed the report online here. (Authored by Michael Mason)
On 20 April, the U.S. Food and Drug Administration (FDA) will host the next virtual Town Hall for SARS-CoV-2 test developers. On 7 April, FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months. On the same day, FDA authorized two over-the-counter (OTC) at-home COVID-19 antigen tests; one to Osang for their OHC COVID-19 Antigen Self-Test, and one to Xiamen Boson Biotech for their Rapid SARS-CoV-2 Antigen Test Card. Also last week, FDA issued a warning letter to Sensory Cloud, Inc for selling unapproved products with unproven COVID-19 claims. On 11 April, the U.S. Centers for Medicare and Medicaid Services (CMS) issued its fiscal year (FY) 2023 Skilled Nursing Facilities Prospective Payment System (SNF PPS) proposed rule; announcing the proposed rule, CMS Administrator Chiquita Brooks-LaSure said, “The COVID-19 pandemic has highlighted serious problems at some of the nation’s nursing homes that have persisted for too long. And we have seen the tragic impact that inadequate staff resources can have on residents and staff.” (Authored by Randy Prebula)
U.S. news: Yesterday, U.S. President Joe Biden tasked the U.S. health department with developing a national action plan to tackle the looming health crisis of long COVID; it will be called the National Research Action Plan and released within 120 days. Biden’s FY-2023 budget request includes $81.7 billion for pandemic efforts over five years. The Administration is also preparing for additional booster shots after greenlighting a second mRNA booster dose for everyone over the age of 50. The new COVID-19 subvariant isn’t yet causing concern among public health officials, but Omicron subvariant BA.2 is at least 30% more transmissible than the original strain and is already the dominant variant in the U.S. The Biden Administration and hospitals are gearing up for another potential case surge. The Administration announced on 4 April that Medicare will cover over-the-counter COVID-19 tests at no upfront cost to beneficiaries through a national demonstration program. In a study published 21 March in Lancet, researchers found that people who had COVID-19 were about 40% more likely to develop diabetes within a year after recovering, compared to participants in a control group. (Authored by Cybil Roehrenbeck)
FDA news: Today, the U.S. Food and Drug Administration (FDA) is holding meeting today of the Vaccines and Related Biological Products Advisory Committee to discuss considerations for use of COVID-19 vaccine booster doses and the process for COVID-19 vaccine strain selection to address current and emerging variants. On Thursday, FDA finalized its vaccine EUA guidance, adding information about its evaluation of clinical data to support effectiveness of a modified vaccine, focusing on immunogenicity analyses. Yesterday, FDA announced sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant. FDA also posted new Q&A for Spikevax (COVID-19 Vaccine mRNA). A large study published last week in the New England Journal of Medicine found that the anti-parasitic drug ivermectin was ineffective in reducing the risk of hospitalization for COVID-19. (Authored by Randy Prebula)
Italy’s recent Law Decree No. 24/2022 (available, here, in Italian), entered into force on 25 March 2022, updating employment related anti-COVID-19 measures. The Decree provides for an extension until 30 June 2022 of the so called “simplified agile work” policies in Italy. We have analyzed the Decree online here. (Authored by Vittorio Moresco)
The UK published new guidance on reducing the spread of respiratory infections, including COVID-19, in the workplace. This replaces the earlier working safely during coronavirus guidance and reflects the fact that now that widespread COVID-19 testing has ended, it will be more difficult to know if a worker has COVID-19, or another respiratory illness. We have analyzed that guidance online here. (Authorized by Ed Bowyer)
FDA news: The U.S. Food and Drug Administration (FDA) authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. FDA issued warning letters to Iodine Products Inc. and Applied Biological Laboratories Inc. for selling unapproved products with unproven COVID-19 claims. FDA also issued warning letters to seven companies for selling CBD products using research studies to claim or imply misleadingly that their CBD products will cure, mitigate, treat or prevent COVID-19: Cureganics; Heaven’s Organics LLC; Functional Remedies, LLC D/B/A Synchronicity Hemp Oil; Greenway Herbal Products LLC; CBD Social; UPSY LLC; and Nature’s Highway. Also this past week, FDA added to its Q&A web page information about leveraging validation data from a study on the adequacy of pediatric self-swabbing to collect a sample for COVID-19 diagnostic testing. (Authored by Randy Prebula)
COVID-19 budget update: U.S. President Biden unveiled his $5.8 trillion FY-23 budget request on Monday, including $81.7 billion for pandemic-related activities over five years. Congress is still wrestling with how to authorize additional funding for COVID-19 after failing to include it in the FY-22 consolidated appropriations bill, as the government has run out of funds for some of its programs, including the uninsured fund. On 6 April, the Health Resources and Services Administration (HRSA) will stop reimbursing providers who vaccinate uninsured people. COVID-19 Response Coordinator Jeffrey Zients said that funding for a possible fourth dose of the vaccine is also at risk as the U.S. Centers for Disease Control (CDC) warns about the Omicron sub-variant. U.S. Sens. Tim Kaine (D-VA), Chuck Schumer (D-NY) Mitt Romney (R-UT), and Sen. Roy Blunt (R-MO) are holding bipartisan discussions on new ways to offset $15 billion or more in supplemental COVID-19 aid. The Administration is still pushing for $22.5 billion it says is needed soon for the government to continue procuring therapeutics, testing supplies, and vaccines for Americans to get a fourth booster shot later this year. Meanwhile, Reps. Ron Kind (D-WI), Nanette Barragán (D-CA), Buddy Carter (R-GA) introduced the Equitable Community Access to Pharmacist Services Act, which would provide coverage for pharmacist services under Medicare Part B, including vaccinations for COVID-19 and influenza, testing for COVID-19, Influenza, Strep Throat, and Respiratory Syncytial Virus and treatment for COVID-19, Influenza, and Strep Throat. Last week, HRSA announced it will distribute $413 million in Provider Relief Fund (PRF) Phase 4 payments to more than 3,600 health care providers impacted by COVID-19. (Authored by Cybil Roehrenbeck)
Other U.S. news: Republican lawmakers are pressuring the Biden Administration to lift the public health emergency (PHE) declaration this year as COVID-19 case counts decline. The PHE is set to expire on 16 April, but the U.S. Health and Human Services Department (HHS) said it would give at least 60 days’ notice before ending it. On 22 March, the Occupational Safety and Health Administration (OSHA) announced a partial reopening of the comment period for the COVID-19 emergency temporary standard for the health care industry, and OSHA said it intends to hold a public hearing on COVID-19 prevention policy for health care providers on 27 April before finalizing the rule. On Thursday, the U.S. House Committee on Space, Science, and Technology will hold a hearing on “The New Normal: Preparing for and Adapting to the Next Phase of COVID-19.” The Africa, Global Health, Global Human Rights Subcommittee of House Foreign Affairs Committee will hold a hearing on "Present Challenges and Progress on COVID-19 in Africa” on Thursday as well. The CDC reported on the use of at-home COVID 19 tests, finding a rapid increase in U.S. at-home test use between the SARS-CoV-2 Delta- and Omicron-predominant periods; at-home test use was lower among persons who self-identified as Black, were aged ≥75 years, had lower incomes, and had a high school level education or less. (Authored by Cybil Roehrenbeck)
Effective 24 March 2022, the Virginia occupational safety and health standard on COVID-19 has been revoked. The standard established protocols that Virginia employers were required to follow to control, prevent, and mitigate the spread of COVID-19 in the workplace and was the first such occupational safety and health standard in the U.S. In place of the standard, the Virginia Department of Labor and Industries (DOLI) is now directing employers to the DOLI’s new nonbinding guidance entitled “Guidance for Employers to Mitigate the Risk of COVID-19 to Workers.” Virginia employers should review the new guidance (including any updates resulting from public comment), as well as safety guidance issued by the Virginia Department of Health. Read more online here. (Authored by George Ingham)
FDA news: The U.S. Food and Drug Administration (FDA) issued an FAQ on at-home COVID-19 diagnostic tests on Friday. FDA announced Monday it will hold a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on 6 April to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants. Moderna is seeking approval for a fourth vaccination shot, pending a grant for emergency authorization use from the FDA, the company announced Thursday. On Monday, FDA issued a Letter to Health Care Personnel to provide recommendations, including conservation strategies, for prefilled 0.9% sodium chloride IV lock/ flush syringes, which are in shortage because of an increase in demand during the COVID-19 PHE. (Authored by Randy Prebula)
Other U.S. news: The Biden Administration continues to push for additional COVID-19 funding, as the budget for uninsured persons to receive COVID-19 treatments will expire unless Congress passes supplemental legislation. President Biden will deliver his FY-23 budget request on 28 March, which will likely give an indication of the Administration's pandemic policy priorities. Given the temporary extension of certain public health emergency (PHE) items in the omnibus funding bill (e.g., certain telehealth flexibilities), it is anticipated that other COVID-related regulatory items may be addressed in forthcoming CMS annual rulemaking. Last week, GAO released a report on COVID-19 emergency relief funds that warned “significant improvements are needed to ensure transparency and accountability.” (Authored by Cybil Roehrenbeck)
FDA news: The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) posted new items on FDA.gov this week, including revised, reissued, and updated Emergency Use Authorizations (EUAs). On Monday, FDA issued a Class I recall for COVID-19 antigen and IgG/IgM antibody tests by LuSys Laboratories because they are not FDA cleared, authorized, or approved. On the same day, FDA also announced it revoked the EUAs issued to LifeHope Labs for the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel, and Omnipathology Solutions Medical Corporation for the Omni COVID-19 Assay by RT-PCR. (Authored by Randy Prebula)
Other U.S. news: The U.S. Congress passed the Consolidated Appropriations Act of 2022 (H.R. 2471) last week, which extends a number of COVID-19 Medicare telehealth flexibilities for 151 days after the end of the Public Health Emergency (PHE), and defers several CMS regulatory actions. It did not include COVID-19 supplemental appropriations, but funding was introduced as a separate stand-alone bill; the House plans to vote on the supplemental measure this week. Without the funds, the Biden Administration says its stockpile of testing supplies and antiviral drugs will be depleted. Yesterday, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a markup of the "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics” (PREVENT Pandemics) ACT. Sens. Thomas Carper (D-DE) and Tim Scott (R-SC) also introduced a bill called the “Hospital Inpatient Services Modernization Act,” which would extend CMS waiver flexibilities brought on by the pandemic to bring hospital-level care directly to patients in their homes. CMS published guidance on clinical laboratory improvement amendments (CLIA) for temporary testing sites under the multiple site exception, which clarifies the PHE-related enforcement discretion as it relates to remote testing. The National Institute of Allergy and Infectious Diseases (NIAID) is conducting a clinical trial designed to help understand rare but potentially serious systemic allergic reactions to COVID-19 mRNA vaccines. CDC invited comments on a proposed information collection project titled “Assessing the Availability of COVID–19 Testing at U.S. Airports.” CDC also issued a report last week on effectiveness of 2-dose BNT162b2 (Pfizer-BioNTech) mRNA vaccine in preventing SARS-CoV-2 infection among children and adolescents. (Authored by Cybil Roehrenbeck)
U.S. President Biden is pushing for $22.5 billion more in supplemental COVID-19 funding, as the White House says the U.S. will run out of critical medical supplies in the coming months unless additional funds are provided; however, many Republicans oppose additional funding given that there is COVID-19 relief money that has not been spent. The White House also published a “National COVID-19 Preparedness Plan” that lays out the roadmap to combat COVID-19 in the future, and public health experts anticipate the Biden Administration will move cautiously in setting new pandemic policies due to the fast-spreading BA.2 Omicron subvariant. Yesterday, the U.S. House Judiciary Subcommittee on Crime, Terrorism and Homeland Security held a hearing on "Reimagining Public Safety in the COVID-19 Era." Last week, the U.S. Centers for Disease Control and Prevention (CDC) released updated guidance for antigen testing for SARS-CoV-2 for health care providers testing individuals in the community. It also released additional guidance and resources to help states maintain Medicaid and Children’s Health Insurance Program (CHIP) coverage for individuals after the COVID-19 public health emergency ends, or transition them to other affordable coverage options. Last, CMS issued a memorandum on 3 March to state health officials regarding continuity of coverage and distributing eligibility and enrollment workload upon conclusion of COVID-19 health emergency. (Authored by Cybil Roehrenbeck)
The American Bar Association’s annual white collar crime conference is often a favorite place for the U.S. Department of Justice to announce new policies and programs, and this year’s meeting in San Francisco was no exception. On 3 March, Attorney General Merrick Garland announced a DOJ hiring spree intended to bolster enforcement of white collar crime. His remarks also emphasized that holding individuals accountable, particularly those engaged in pandemic-related fraud, is a top priority for DOJ. At the same conference, the head of DOJ’s Criminal Division, Assistant Attorney General Kenneth Polite, discussed several programs designed to benefit victims of white collar crimes. Read more online here. (Authored by Peter Spivack)
On 17 March, Hogan Lovells Life Sciences & Health Care Senior Associate Madeline Gitomer will be featured in a panel discussion during the “Data Privacy & Public Health: The Impact of Covid-19 & Where We Go From Here” webinar hosted by the Executives for Health Innovation. This panel is the second in a series of online events focused on modernizing the public health system. Read more about our upcoming privacy & cybersecurity events online here.
The UK government’s Living with COVID plan removes the legal requirement in England for people who have COVID to self-isolate. However, government advice remains that those testing positive should stay at home and avoid contact with other people. This means that employers’ approaches to managing COVID risk in the workplace are unlikely to change significantly, at least in the short term. (Authored by Ed Bowyer)
FDA News: Yesterday, the U.S. Food and Drug Administration (FDA) issued three safety communication warnings over the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging, the SD Biosensor STANDARD Q COVID-19 Ag Home Test, and the ACON Laboratories Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). Last week, FDA had revised the emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab) to change the initial dose for the authorized use as pre-exposure prophylaxis of COVID-19 in certain adults and pediatric patients. FDA also updated its FAQ web page on antibody tests for SARS-CoV-2, as well as its antibody testing information page. Last week, CDRH also added meeting materials to its Virtual Town Hall Series web page. (Authored by Randy Prebula)
U.S. News: President Biden discussed updated COVID-19 guidelines and getting the U.S. workforce back to work during last night’s State Of The Union address. Biden has extended the national emergency declaration for the COVID-19 pandemic, and the administration said it does not plan to terminate the separate “public health emergency” (PHE) designation used for Medicaid and entitlement program waivers on 15 April; instead, it will give health care groups at least 60-days’ notice when it plans to do so. The National Institute for Health Care Management Foundation held a virtual discussion yesterday on "Addressing Rural Health Needs: COVID-19, Equity and Access to Care." Last week, the Centers for Disease Control and Prevention (CDC) published a report on “Hospitalizations of Children and Adolescents with Laboratory-Confirmed COVID-19,” as well as a report on “Pediatric Emergency Department Visits Before and During the COVID-19 Pandemic.” On 25 Feb., CDC relaxed its mask guidance for communities where hospitals are not under high strain. Also last week, Sanofi and GlaxoSmithKline said they intend to seek regulatory authorization for their COVID-19 vaccine in the U.S. and Europe amid the release of data they say is comparable to those from other authorized vaccines. (Authored by Cybil Roehrenbeck)
Compiled by Aaron Armstrong
Medical device 510(k) submissions must be electronic by October 2023, FDA says
Meta ban on health-targeting ads will soon restrict clinical trial recruiters
Government declines to appeal ruling in PBM accumulator programs MDRP final rule litigation
World Stem Cell Summit offers guidance on positioning your regenerative medicine start-up for success
Panelists discuss present & future reimbursement mechanisms for AI health care products
FDA invites comments on xenotransplantation product regulatory standards ahead of public meeting
FDA outlines rescission of Breakthrough Therapy Designation
Demy-Colton panel explains importance of U.S. market access planning ahead of Phase III trials
Demy-Colton panel explains how to make your market access strategy real ahead of Phase III trials
Immunoglobulin Therapies in the US: How they are used, a Roundtable Report
FDA issues ambitious new draft guidance to promote clinical trial diversity
OIG green lights drug manufacturer-sponsored genetic testing program
MDRP: CMS issues Manufacturer Release on multiple best prices reporting option for VBPs
HHS highlights significance of new health care technologies in series of regulatory actions
FDA issues final guidance for importing drugs prior to anticipated approval
FDA proposes to conform the Quality System Regulation to the ISO 13485 standard
New FDA proposed rule will eventually preempt state drug wholesaler/3PL licensure laws
FDA finalizes guidance on premarket pathways for combination products
Episode 2: Clinical Trials Information System
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