What if the people involved in the review of your application at the FDA got fired? It is not an anecdote but the reality that hit several companies last week. What is expected from the sponsors working with those individuals who are no longer employed by the FDA? It’s a tough question. There are some challenges but also opportunities that might emerge from this situation.
The firing of the FDA personnel is an administrative event unlike the pandemic related workforce adjustments that were driven by a health emergency. It does not change the regulatory responsibilities of the FDA or the sponsors. Legally, the statutory timelines and commitments are not affected by the firing of personnel. On the contrary, this is projected to make the FDA more “efficient” by eliminating the “waste” that was “hindering” productivity. All the personnel firings at the FDA were done in the name of performance deficiencies. Which technically means that the fired personnel were not working as expected and the remaining ones are doing their jobs well. With those assumptions, the sponsors are expected to file their submissions and the FDA is, in turn, expected to respond appropriately on time.
Sponsors should not delay or postpone any of their planned interactions with the FDA. The scheduled meetings will happen as planned, the submissions should happen as before, adverse events should be reported per the regulatory timelines, and FDA inspections should happen as prearranged. That said, we should expect the FDA to be under pressure to accommodate their jobs with the reduced personnel. There was no time to plan transitions as all the firings were instantaneous. The tasks handled by the fired employees would need to be transitioned to those remaining which might take some time. The remaining FDA employees are scared for their jobs. They fear that if they start delaying applications for lack of sufficient personnel, they may also lose their jobs for being “disloyal” and not being efficient. So, decisions will be made fast. Which in turn means long work hours at the FDA. So, sympathize with your reviewers, if nothing else. They are trying to keep their jobs.
This also creates a unforeseen opportunity. Ex-employees of the FDA were always attractive hires for the industry. These inviduals come with a wealth of information on internal processes at the FDA, and first-hand experience with the products they reviewed. So, you might want to hire the FDA reviewer who suddenly became available, thanks to this purge. Ironically, the fired employees have been encouraged to find jobs in the public sector, so why not take advantage of that. With more than 2000 ex-FDA employees suddenly becoming available in the job market, many of them at prominent decision-making positions at the FDA, there is an immense opportunity to enrich corporate regulatory intelligence. Even the employees left at the FDA would likely be targeted by recruiters as even if they escaped firing this time, they are left with a job that no longer has the allure of job security and respect it had a month ago. The industry can step in and rake in the regulatory gems.
