Expert Pitch

Vaccine developers to heed FDA rules, despite White House

Cornell University
6-Oct-2020 11:40 AM EDT, by Cornell University

The White House has blocked new Food and Drug Administration guidelines on vaccine approvals that would almost certainly have prevented the release of a vaccine before the Nov. 3 election.

Colleen Carey, assistant professor of policy analysis and management at Cornell University, is an expert health care economics and federal regulations of health care policy. She says vaccine developers will likely follow FDA guidance despite the White House’s efforts to block it.

Bio: https://www.human.cornell.edu/people/cmc528

Carey says:

“The White House blocked this most recent guidance, but the guidelines have already been widely publicized. If vaccine developers are reading the news, they know what the FDA would like to see, and it doesn't matter that it wasn't published in formal ‘guidance.’ The whole episode showed vaccine developers two key facts about our current situation: (1) the FDA would like the vaccine to have these features and will recommend rejection if it doesn't and (2) The current White House will attempt to override the FDA's decision. 

 “Given these two facts, I expect vaccine developers to wait to assemble the data that the FDA wants, rather than subjecting themselves and the FDA to a massive political imbroglio if they submit data that the FDA has signaled it won't approve. Protecting themselves and their relationship with the FDA is going to outweigh the benefits of getting to market two weeks earlier.”




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