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.
One of most profound lessons from the COVID-19 pandemic is the potential public health value of advanced manufacturing to avoid global supply strains and accelerate the production of medical countermeasures. Under the leadership of the U.S. Food and Drug Administration (FDA), the International Council for Harmonisation (ICH) recently published Q13 draft guidelines on continuous manufacturing (CM) to advance the brand and generic drug industries ability to obtain approvals for products manufactured using CM processes in multiple regions. The ICH Q13 guideline is an important milestone in clarifying the regulatory paradigm for more flexibility and reliability in manufacturing processes. The ICH guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of CM in small and large molecule drug products. While FDA has not yet adopted the ICH’s guideline to apply to biological products, it is expected that both CDER and CBER will continue to prioritize the agency’s efforts to promote CM to improve quality and increase supply chain resilience. We analyzed the ICH guidelines in detail online here. (Authored by Lowell Zeta)
As part of the Biden-Harris Administration’s stated commitment to increasing access to vaccinations and improving health equity, the U.S. Centers for Medicare & Medicaid Services (CMS) is permitting health care providers to receive additional payments for administering vaccines to multiple residents in one home setting or communal setting of a home. CMS announced on 24 August that this move aims to further boost the administration of COVID-19 vaccination – including second and third doses – in smaller group homes, assisted living facilities, and other group living situations by allowing vaccine providers to receive the increased payment up to 5 times when fewer than 10 Medicare beneficiaries get the vaccine on the same day in the same home or communal setting.
On 22 August, FDA updated the Pfizer-BioNTech emergency use authorization (EUA) to support the extension of shelf-life of the Pfizer-BioNTech COVID-19 Vaccine stored at -90 degrees to -60 degrees Celsius from 6 months to 9 months. The extension is also applicable to batches that might have expired prior to the EUA amendment, provided the product was stored at the same temperatures. Separately, as part of FDA’s stated effort to protect consumers, on 19 August, FDA issued a warning letter jointly with the Federal Trade Commission (FTC) to Mahita, LLC (dba 'PushMyCart") for selling unapproved products with unproven COVID-19 claims. (Authored by Randy Prebula)
Following the U.S. Centers for Disease Control and Prevention's (CDC) recent changes to its COVID-19 guidance, the Occupational Safety and Health Administration (OSHA) updated its COVID-19 guidance for non-health care settings to reflect more restrictive recommendations for employers in light of the increased transmissibility of the delta variant. Among other things, OSHA advises U.S. employers to require fully vaccinated workers to wear face coverings in indoor public settings in areas of substantial or high transmission and to encourage unvaccinated workers to become vaccinated as soon as possible. OSHA expressly recommends that employers consider mandating the vaccine and requiring regular COVID-19 testing for employees in the workplace who remain unvaccinated, an approach recently recommended by the White House. We analyzed OSHA's updates in greater depth online here. (Authored by George Ingham)
Last week, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. This action does not apply to people who are not immunocompromised. Separately last week, FDA also issued a warning letter to Secret of the Islands for selling unapproved products with unproven COVID-19 claims. In the letter, FDA provided Secret of the Islands with 48 hours to advise the agency on steps it is taking to review its websites, product labels, and other labeling and promotional materials to ensure the company is not misleadingly representing its products as safe and effective for a COVID-19-related use for which they have not been approved. (Authored by Randy Prebula)
The U.S. Department of Health and Human Services (HHS) has, in no uncertain terms, rebuked early courts’ narrowed interpretations of Public Readiness and Emergency Preparedness Act (PREP Act) immunity head on. Yet, as indicated by the recent federal court decision Avicolli v. BJ’s Wholesale Club, Inc., which we analyzed online here, the U.S. judiciary appears poised to continue applying a narrower reading of the PREP Act where possible. Avicolli suggests that a retailer obtaining hand sanitizer for re-sale before the pandemic would presumably be excluded from immunity under the PREP Act, unlike a retailer that obtained a product after the start of the pandemic to specifically assist in mitigating the spread of COVID-19. Regardless, establishing a timeline of such purchases may be important to a PREP Act immunity defense and may, at least in some courts, determine whether a defendant can limit its liability for COVID-19-related claims. (Authored by Lauren Colton)
As Colorado employers prepare to reopen their offices following the COVID-19 pandemic, they must consider a number of legal issues. Some key considerations include whether employers can ask about vaccination status, whether they can mandate vaccines or incentivize employees to get vaccinated, and how to apply the Center for Disease Control’s (CDC) and Colorado’s most updated guidance. Our analysis of a post-pandemic return-to-office policy in Colorado online here clarifies the confusion surrounding these issues. (Authored by Michael DeLarco)
Ivan Zapien, partner and practice leader of the Hogan Lovells Government Relations and Public Affairs practice, focuses his podcast on the issues, people, and culture that help shape Washington, D.C. In his recent podcast episode online here, "How COVID-19 has changed the way we manage crises and communication," Ivan chats with Lillian Hardy, partner at Hogan Lovells, and Matthew Miller, partner at Vianovo, about how to manage a crisis in a crisis and communicating in the COVID-era.
Effective 9 August 2021, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) will expect all facilities with FSIS inspectors present to require employees or contractors to wear masks, regardless of vaccination status, if the establishment is located in a county with “substantial” or “high” community COVID-19 transmission, consistent with recent guidance from the CDC. Read more online here. (Authored by Brian Eyink)
On 29 July 2021, the Biden Administration announced a wave of White House programs to boost vaccination rates in the U.S., including programs aimed directly at federal contractors. These initiatives, summarized in a Fact Sheet released the same day, will require federal workers and “onsite contractors” to follow new safety protocols, including vaccination attestation requirements, although they do not amount to a vaccination mandate. The initiatives are not currently embodied in an executive order, and implementation is largely left to the discretion of federal agencies. Contractors will need to make judgment calls on various compliance questions that the Administration hasn't yet addressed. Read more online here. (Authored by William Ferreira)
Citing concerns about potential spread of the COVID-19 “Delta variant” and the fact that even fully vaccinated individuals infected with the Delta variant can spread COVID-19 to others, on 27 July 2021, the U.S. Centers for Disease Control and Prevention (CDC) reinstated some safety measures that it lifted in May, including now recommending that fully vaccinated individuals wear masks in public indoor settings in areas of substantial or high transmission. We summarized these safety measures online here. (Authored by Michael DeLarco)
Last week, the U.S. Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for baricitinib (sold under the brand name Olumiant) now authorizing baricitinib alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Under the revised EUA, baricitinib is no longer required to be administered with remdesivir (Veklury). Baricitinib is not FDA-approved as a treatment for COVID-19. Additional information is available online here. (Authored by Randy Prebula)
As national COVID-19 related restrictions begin to ease, our new employee vaccination and testing cross-border guide provides a quick overview of the key questions and issues for employers as staff return to the workplace across a range of jurisdictions. Our color-coded guide highlights the extent to which employers have the ability and freedom to implement policies on vaccination and testing, and addresses: whether vaccination is mandatory under local law in different jurisdictions; employers’ ability to ask employees if they have been vaccinated, or require vaccination as a condition of employment; and how far employers can impose testing requirements as a condition for entry to the workplace. The guide also highlights other steps that employers can take to encourage employee vaccination where this is not mandatory under local law. (Authored by Philip Cheng)
Compiled by Aaron Armstrong
After a long and winding road, FDA finalizes much-debated “intended use” rule
PhRMA responds: Code on Interactions with HCPs updated following fraud alert on speaker programs
FDA seeks comments on how to transition approved drug products to device status under Genus
“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices
Time’s really up! FDA authority to crack down on regenerative medicines upheld as grace period ends
New FDA guidance lays out clinical trial sponsor safety reporting requirements
FDA leads global work on continuous manufacturing approaches to up quality, supply chain resilience
What health systems should know about President Biden’s Executive Order Promoting Competition
FDA offers guidance on clinical trial waivers for investigators at non-U.S. sites
COVID-19 Report for Life Sciences and Health Care Companies (July 2021)
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