Wednesday, November 14, 2012

All the President's Men and Antibiotics

A recent article by Matt Herper in Forbes caught my attention.  The article provides a nice, historical review of the politics of how the FDA got where it now is on antibiotics – it’s a great read  (but not as good as my book).   He makes two key points.  (1) Presidents rarely directly influence FDA activities on the ground.  Its not a subject that comes up in campaigns because there are no political points to be scored here.  (2) Congressional politics, however, have become very much a part of how the FDA behaves.  Since the Ketek scandal, the Anti-infectives division has been spending about 50% of its time responding to congressional inquiries.  Is that a waste of time or what?

Lessons I have learned – In dealing with the FDA – there is no higher authority there to receive an appeal.  Congress has been useless – more of an obstruction than a help.  The GAIN act, other than its language offering the FDA some political cover for accelerating antibiotic approvals and aside from its aid to a few antibiotics with short patent lives, is one example.  The other is the constant meddling in FDA considerations that provides more of a distraction from real business than anything else. The administration is another false hope. At one point, when I thought I was not getting any response from the FDA in dealing with its completely infeasible guidance documents for antibiotic development, I believed that our only way forward was to appeal to the head of the Department of Health and Human Services.  This certainly worked for the anti-abortion folks when HHS overruled FDA on Plan B. But for antibiotics it was a non-starter.  There was no (or not enough) political gain in supporting the development of new antibiotics.

At the end of the day, somehow, between the IDSA, I will take some credit here, and the pharmaceutical industry, the FDA itself realized that they truly were going to oversee the end of antibiotics in the US unless they changed course.  Was this Rachel Sherman, a pediatric infectious disease physician in the FDA commissioner’s office?  Was it Peggy Hamburg herself – a public health advocate with intimate familiarity with the scourge of resistance through her experience in New York with multiply-resistant TB?  Was it Janet Woodcock?  Ed Cox?  I have no idea.  What I think it was not was congress, HHS or Obama.

Why did it take the FDA so long to get to this point?  Who knows?  How long will they now take to complete their reboot process for antibiotics?  Same answer.  They do tell me that they are making good progress on new approaches for “unmet needs” – new antibiotics targeted at treating small numbers of patients with serious infections caused by extensively resistant organisms – those for whom little or no other therapy is available.  They are having a harder time revamping their old and still infeasible guidance documents on more traditional infections disease indications like skin infections, pneumonia and others.

As always – we await further developments.

Next on the Blog list – a continuation of our series on writing grants on antibiotic discovery with Guest Blogger Lynn Silver! And – a summary of the recent European Medicines Agency’s  Workshop on their Addendum to the Guidance for the Development of Anti-Bacterial Drugs with another Guest Blogger who was actually there!

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