Nicholas Florko, Stat News: May 19, 2020
WASHINGTON — Two top Food and Drug Administration officials, suddenly at the center of the White House’s effort to speed approval for Covid-19 vaccines, will recuse themselves from the agency’s considerations about whether to approve those products, according to an email obtained by STAT.
The move is designed to lessen conflict-of-interest concerns, since the FDA’s mission is to skeptically review safety and efficacy evidence for drugs, not push for their approval. On Friday, President Trump formally unveiled Operation Warp Speed, the administration’s new effort to accelerate development of potential Covid-19 treatments and vaccines. The initiative’s stated goal is to help bring a Covid-19 vaccine to market by the end of the year. The project is focusing on 14 vaccine candidates, which the government has not publicly named. It will be headed by Army General Gustave Perna and former GlaxoSmithKline executive and venture capitalist Moncef Slaoui.
Janet Woodcock and Peter Marks, who head the FDA’s drug and biologic centers, respectively, will oversee Warp Speed’s efforts on therapeutics and vaccines. But the inclusion of top FDA brass in the effort almost immediately raised concerns for activists who have long sounded the alarm over industry influence at the FDA.
“For such senior FDA officials to be serving on the public-private partnerships blurs the line between the FDA and regulatory industry to an unprecedented degree,” said Michael Carome, director of Public Citizen’s health research group. “Such relationships could undermine the integrity of the FDA’s review of medical products that result from this partnership.”
Another advocate, National Center for Health Research President Diana Zuckerman, who has long complained that the FDA is lowering its approval standards, called the news “beyond frightening.” “It makes sense for FDA to work together with companies trying to develop a vaccine, to make sure the companies are gathering appropriate data for approval and to speed up the process as much as possible,” Zuckerman said.“But the FDA has repeatedly lowered its standards for getting tests and drugs on the market during the pandemic, and vaccines can do more harm than good if not tested adequately.”
Peter Lurie, a former FDA associate commissioner who now leads the Center for Science in the Public Interest, likewise added: “I do not think it is appropriate for officials from a regulatory agency like FDA to be involved directly in this effort, especially one that prioritizes speed in its very name.”
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