Earlier this week, the U.S. Senate HELP Committee released a discussion draft of the “Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act” (“PREVENT Pandemics Act”), a sweeping package broadly intended to better prepare for future pandemics as well as the ongoing COVID-19 pandemic. Because the discussion draft carries bipartisan sponsorship, it is possible that at least some parts of it could ultimately be enacted into law.
Several sections of the proposed legislation – relating to the use of real-world evidence (RWE), advanced platform technologies, and foreign facility inspections and registration – may have an immediate and significant impact on pharmaceutical and biotechnology companies, and we have summarized these key provisions below.
The PREVENT Pandemics Act would change how the U.S. Government monitors disease outbreaks, stockpiles supplies, and responds to future pandemic threats. In introducing the discussion draft, Sens. Richard Burr (D-NC) and Patty Murray (D-WA) issued a press release stating: “As the response to COVID-19 continues to evolve, we must reflect on the lessons learned from the last two years and determine where we were successful, where we failed, and what we did not anticipate so we are better prepared for the next threat we face. This discussion draft starts that conversation.”
While the 205-page discussion draft of the proposed legislation contains many significant provisions to improve U.S. public health infrastructure, four measures that may be among those of greatest interest to pharmaceutical and biotechnology companies are:
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Section 505, “Facilitating the use of real world evidence,” which would require the U.S. Food and Drug Administration (FDA) to issue or revise guidance on the use of real-world data (RWD) and real-world evidence (RWE) to support regulatory decision-making, including with respect to RWE from products authorized for emergency use. While FDA has already issued a suite of RWE-related guidance documents this past year, FDA has not explicitly addressed the use of real-world performance of medical products distributed under Emergency Use Authorization, to support full marketing approval.
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Section 506, “Advanced platform technologies,” which would create an advanced platform technology designation (by inserting “Sec. 506K. Advanced Platform Technology” into the Federal Food, Drug, and Cosmetic Act (FDCA)) to expedite the development and review of new treatments and countermeasures that use cutting-edge, adaptable platform technologies that can be incorporated or used in more than one drug or biological product. This measure would require FDA to issue guidance on the implementation of this new designation within a year of enactment of the PREVENT Pandemics Act. In addition, major changes to an advanced platform technology may be made by FDA approval of a supplemental application, which could potentially allow a more streamlined approach for developers to tackle new variants or strains sooner so that patients and their families have access to essential medicines earlier.
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Section 511, “Ensuring registration of foreign drug and device establishments,” which aims to clarify that all foreign drug and device establishments that manufacture or process drugs or devices intended to be marketed in the United States must register with FDA, including products manufactured at an establishment that are not directly imported into the U.S. This proposal aims to address concerns about the quality of drugs manufactured abroad, in particular, a loophole that regarding registration of foreign facilities that manufacture API for OTC monograph drugs (and avoid inspection).
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Section 513, “Unannounced foreign facility inspections pilot program,” which also addresses concerns over drugs and medical devices manufactured outside the U.S., and would require FDA to conduct a pilot program to increase the conduct of unannounced inspections of foreign drug facilities. Under this measure, FDA would have 180 days from the enactment of the PREVENT Pandemics Act to initiate the pilot program, and then 180 days from the pilot program’s completion to issue a report evaluating: any differences between unannounced and announced inspections, barriers to conducting unannounced inspections, and challenges to achieving parity between domestic and foreign human drug establishment inspections.
Other measures included in the discussion draft of particular significance to pharmaceutical and biotech companies relate to modernizing clinical trials by promoting the use of digital health technologies, decentralized clinical trials, inclusion of more diverse populations in clinical studies, and other innovative trial designs (Sec. 502); increasing EUA decision transparency (Sec. 507); improving FDA guidance and communication (Sec. 508); strengthening medical device supply chains and preventing medical device shortages (Secs. 515 and 516); and utilizing remote records assessments for medical devices (Sec. 517).
A section-by-section overview of the draft was also made available here. Feedback on the discussion draft is due February 4, 2022, and the Senate HELP Committee plans to mark up a final bill in the coming weeks. We will continue to track this far-reaching legislation and keep you apprised of any changes. If you have any questions on the bill, or may wish to submit a comment, you may contact any of the authors of this alert or the Hogan Lovells attorney with whom you generally work.
Authored by David Horowitz, Lowell Zeta, and Sally Gu
