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).
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