FDA Leadership Shifts to Advance COVID-19 Treatments

There’s been considerable hat-changing in FDA leadership during the past week, as the White House looks to bring in credible experts for its Operation Warp Speed initiative to advance therapies and vaccines to combat the coronavirus pandemic. This prompted major leadership changes at FDA, with Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), stepping down temporarily from that role in order to head up the administration’s efforts to identify and accelerate development of promising treatments and preventives pending development of a new vaccine against COVID-19. Woodcock is being detailed to the office of FDA Commissioner Stephen Hahn during this assignment.

At the same time, Peter Marks will remain as head of the Center for Biologics Evaluation and Research (CBER), instead of shifting over to direct vaccine development under Warp Speed. FDA initially said that both of these top officials would be involved in leading the administration’s public-private partnership to speed new therapies, vaccines, and diagnostics to the public and would recuse themselves from evaluating regulatory applications to avoid potential conflicts of interest. However, concerns about maintaining clear distinctions between funding research on promising treatments and serving as the final FDA arbiter of new product approvals prompted the revised assignments.

While Woodcock leaves CDER for Warp Speed, the center will be led by deputy director Patrizia Cavazzoni, with support from Doug Throckmorton, deputy director for regulatory programs, Grail Sipes, deputy director for regulatory policy, and Bob Temple, deputy director for clinical science. Woodcock’s work will support FDA’s Coronavirus Treatment Acceleration Program, which aims to bring new therapies to patients as quickly as possible while also supporting research to further evaluate these medical countermeasures, Hahn said on Twitter.

Hahn further explained that Marks will remain at CBER to accelerate vaccine testing and development and support collaborative regulatory work with industry, federal, domestic, and international partners. This change to have Marks step away from the Warp Speed role is supported by strong vaccine expertise leading the administration’s partnership. Moncef Slaoui, former vaccine chief at GlaxoSmithKline and board member of vaccine developer Moderna, heads up the initiative. The vaccine team also is supported by Matt Hepburn, who has more than 20 years experience in vaccines and public health at the Department of Defense, along with several other experts from the Defense Health Agency.

By remaining at CBER, Marks will be positioned to lead FDA efforts to review vaccine and therapeutic candidates and applications supported by the national partnership, while also avoiding policy conflicts that could arise from being in a position to select certain drug and vaccine candidates for government funding and support, while also evaluating research studies and applications for market approval.

The potential for such conflicts were raised after the initial announcement of the dual roles for Woodcock and Marks. Critics noted that being involved with efforts to produce a viable COVID-19 vaccine by the end of the year would make it difficult to also evaluate what kind of data are needed to support approval of products to treat this relatively unknown disease. The Public Citizen health research group pointed out that having FDA executives on the White House task force could undermine the agency’s strong reputation for setting the “gold standard” for credible biomedical research and could raise questions about the integrity of the agency’s review of medical products funded by the administration’s initiative.

Meanwhile, Operation Warp Speed in moving forward. The program made headlines last week with its decision to award $300 million to AstraZeneca to provide at least 300 million doses of its experimental coronavirus vaccines now being tested in collaboration with the University of Oxford in the United Kingdom.