David's New Book

Saturday, March 29, 2014

The FDA and Me



Some of you may remember that last Fall, in the midst of the government shut down, I wrote a blog publicly expressing my desire to work (once again) for the federal government – specifically for FDA.  I offered my services free of charge starting this year since I planned on retiring from my consulting business December 31st of last year. I also felt that my retirement would free me of any conflicts of interest that the FDA might be concerned about.  I thought that I would provide you faithful readers with an update of my interactions with the FDA on this topic.

I was rejected.  Of course, I feel I have been rejected by more attractive places to work in the past.  In fact, in my consulting business, I found that sometimes, when I gave a negative opinion about a company’s sole asset, I was rapidly fired.  Some companies with more than one asset would listen to negative opinions and stop pursuing whatever avenue I criticized – but that also put me out of a job with them. And, as an academic, trying to publish papers and get grants funded, I can tell you that I’ve had a lot of experience with rejection.  I can take it. But I was particularly disappointed with FDA’s rejection.

My primary motivation for working with FDA was to help the commissioner’s office understand the real world impacts of the policies that the Division of Antimicrobial Products was putting in place through their constantly changing (recently mostly for the better) guidance documents on the development of antibiotics. I felt that the commissioner’s office – primarily Janet Woodcock – had their hearts in the right place.  It just seemed that they did not have the technical expertise to properly evaluate what the Division was doing.  Their main expert, Rachel Sherman, was about to leave the FDA (and has since left I understand). Around this time, Bob Guidos of the Infectious Diseases Society, left his job there and started to work at FDA.  I still don’t know what he does there – but there he is.

I started my contacts with the FDA in late November.  I wrote Dr. Woodcock and we arranged to speak in December – Bob Guidos joined our conversation. Dr. Woodcock pointed out that I would be unable to work for them for free – they would have to pay me.  Well, OK then. I then provided, at their request, a written summary of areas where I thought I could help.  Specifically, I mentioned considerations in the design of small superiority trials in areas of unmet needs and the design and definition of endpoints in more traditional non-inferiority trials.  I emphasized various ways we could use pharmacometrics to help in these considerations. I spent some time on the mortality endpoint for hospital-acquired pneumonia that I still think is the wrong way to go. Over the next month, Bob got back to me asking for more details whereupon I sent him several of Paul Ambrose’s papers with an explanation of the approaches I was considering.  I pointed out that the FDA had much of the data that we would need to carry out the appropriate analyses and that we could always get Paul or George Drusano to help.

And that was that. I have had radio silence since January and have concluded that I have been rejected. Maybe they have hired Paul or George – but I don’t think so. Of course, I really shouldn’t be surprised.  I have been extremely critical of them for years – probably since around 1999-2000.  I thought of it as tough love – and I thought they did too – but maybe not.


Don’t worry. I am now going to pursue other outlets for my desire to continue to be active in the area of policy on the discovery and development of new antibiotics where I think we still have lots of work to do. (Hint – pricing and economic considerations).