Is FDA in Trouble: NY Times Thinks So 
[Thursday, January 16, 2020] 

FDA is approving new drugs and medical devices too fast, its reviewers are leaving for jobs in the industry they regulate, and it is critically short on resources, the editors of the New York Times opined this week. Another article this week in the Journal of American Medical Association (JAMA) by Harvard researchers, raised similar concerns about fast FDA approvals based on reduced data. These opinions are based on an increasingly popular perception that FDA’s is aggressive about approving new drugs even with limited evidence and pending additional testing. To some extent it is true that increasing number of new approvals are based on one or few clinical trials, smaller clinical trials, and using unconventional endpoints and study designs. But most of such approvals are for drugs intended either for rare diseases or for diseases with no treatment options. Nobody is complaining about giving patients some options. FDA has approved more first-in-class treatments in the recent years than any time in its history. And this is based on concerted efforts in the Congress to pass new laws that created regulatory pathways allowing such approvals and increased activism by patients with rare and/or untreatable diseases, only supported by FDA but not lead by FDA. The perception has been created by the anecdote that less data means less-safe products, which ironically was created by FDA over decades as a rationale for ask for increased data to support market approvals. The NY Times editors suggest that FDA should slow down on approvals but that’s wishful thinking. The JAMA article contents similarly that FDA should rethink the utility of approvals based on smaller datasets. However, the regulatory pathways and the precedence created by FDA are almost impossible to turn back. More importantly, they should not be. There is ample evidence that several of these new products have helped patients and apparently no harm has been done. Regarding FDA’s revolving door, government cannot make policies prohibiting its former employees to seek other job opportunities. Industry actively poaches FDA’s employees seeking insight into FDA’s internal processes. Just like the concern about FDA’s review processes, the revolving door concern is more about perceptions than the realities. There is no known evidence that former FDA employees are better than industry veterans at the regulatory processes. The last issue regarding FDA’s shrinking resources is probably the closest to reality. FDA’s mandate and public expectations from it have been constantly increasing over the years. While the user fee model has helped provide the Agency with additional monetary resources to support the industry it regulates, the scope of responsibilities has also increased unproportionally. It seems like the FDA is constantly playing catch-up with the additional resources needed to fulfil increases mandate. But it is a stretch to say that FDA is in trouble. It is probably medias-speak for increasing eye-balls. And that’s all there is to it.