David's New Book

Monday, November 7, 2016

FDA Needs a Few Good People - But Can't Hire Them

A recent article in the Washington Post caught my eye.  The FDA apparently has over 700 vacancies in its drug evaluation group. This lack of resource is holding up drug reviews. According to the piece, Dr. Janet Woodcock complains that qualified candidates would much rather work in industry because the salaries are so much higher.  But she also goes on to explain the draconian hiring process at the FDA where all potential conflicts of interest must be reviewed and rectified before the person is hired.  And this says nothing about the lengthy federal candidate review process.

I agree with Josh Sharfstein who says the problem is not just the salary.  It’s the rest of the process.  To be hired, one has to divest all stocks or other investments in companies that might pose a conflict of interest – as in virtually all pharmaceutical companies. This probably excludes most folks with the kind of experience the FDA actually needs in its reviewers.  That is, people who have worked in industry designing and carrying out clinical trials designed to get drugs approved by the FDA. Given the devastation that’s been occurring because of pharmaceutical company consolidation, there are lots of experienced folks out there who might be interested in working for the FDA.  But who wants to go through the process, divest all of one’s pharmaceutical company stock and then wait three months for news as to whether one can be hired or not?

What is the FDA doing now?  They use contractors.  I admit that I don’t know what regulations there are for conflict of interest for contractors – but I expect they are not as draconian as those for full time employees.

And then there are folks like me.  I’m retired.  I wanted to work at the FDA on a voluntary basis – expecting that they would pay my expenses – but no salary.  I strongly believe that we need the FDA and we need it to be effective and efficient – something that the antibiotics group has not been until recently. In retrospect, the particular role I wanted to play is probably superfluous at this point since the antibiotics group is now functioning much better than it was at the time – albeit more slowly than I would like. But in my discussions with them, they noted that I would have to be a contractor and they would have to pay me. Hmmm . . ..  .As it turned out, they didn’t avail themselves of my services – probably because they thought they had things covered internally at that point (and they seem not to have been wrong).  But I’m not sure that I would have met their conflict of interest criteria either as a contractor or even as a volunteer given my experience in the pharmaceutical industry.

So who do they hire? The most likely candidates would be those coming from academia. They probably have little experience in the areas where the FDA needs expertise – so they get trained while working at FDA. The same problem exists for the FDA advisory boards where there is dearth of industry experience and key recommendations frequently lack the insight that previous industry-based trial experience can provide. It turns out that the academics on the advisory boards are probably just as conflicted as industry folks might be. The young clinical reviewers that might be hired from academia will not be at the same level of experience as those on advisory boards and hence would be free of those conflicts.  But they would also be free of experience.  Is that a good thing?  I’m not convinced that it is.


 So, while I think that increasing salaries for new hires at the FDA is a good thing, it is not nearly enough to crack this problem.  The FDA has to reinvent itself in a way that allows it to take advantage of the experience and gray hair that is now abundantly available in the world outside the federal government. Given the paranoia about conflict of interest, I expect that this won’t happen tomorrow.  But we need to at least start the conversation before this opportunity simply goes away with age and evolution to other interests.