Saturday, July 31, 2010

FDA's Woodcock Testifies on Antibiotics

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But I don’t get it.

Dr. Janet Woodcock testified before the committee on energy and commerce subcommittee on health in the US House of Representatives in June.  Her full testimony can be viewed and downloaded via the link below:

Dr. Woodcock is a scientist for whom I have the greatest respect.  She was the originator of the FDA’s Critical Path whitepaper that was an important recognition of the regulatory implications of personalized medicine for drug development.  But I am afraid that her testimony in June is more a political statement designed to shield the agency from congressional criticism rather than a real world assessment of the FDA’s current position in the war against resistant bacteria.

Dr. Woodcock notes that the “FDA is working to provide scientifically sound guidance to industry on demonstrating the safety and effectiveness of new antibacterial drugs, particularly on indication-specific trial designs used to study a new drug.”  She goes on to point out the challenges faced by antibiotic drug development in the sense that non-inferiority trials where one antibiotic is compared to another assume superiority of the comparator to placebo – something that most often was never proven in a placebo controlled trial since these are mostly viewed as unethical.  You can’t not treat someone with a serious infection.

Dr. Woodcock then goes on to cite FDA’s list of recently released guidance or draft guidance documents related to antibiotic development.  We, and congress, are supposed to believe that the FDA has actually made progress.  A careful look at the guidance documents she cites provides more angst than reassurance.  The placebo controlled trial designs required for registering a new antibiotic for otitis media, sinusitis and bacterial exacerbations of bronchitis are all infeasible since no one will be able to get sufficient numbers of patients to enroll in such trials.  Moreover, in the case of moderate to severe exacerbations of chronic bronchitis that are associated with bacterial infection, it would be unethical to withhold antibiotics from patients.

The guidance on trials in community-acquired pneumonia was apparently obsolete upon its release since the FDA had to backtrack after the extent of the response from sponsors and the public.  This guidance is being substantially reconsidered and will almost certainly be revised.  I’m still not sure that we will end up with feasible design requirements at the end of the day.

Dr. Woodcock rightly states that clear guidance will not be enough, but that incentives will probably also be required to assure a continuing pipeline of new antibiotics active against resistant bacteria.  But, if the trial designs required for registering these new antibiotics are infeasible, where are we?  No incentive in the world can overcome that obstacle. 

I am hoping that congress will see through the FDA claims of progress and realize that the only progress we are making on the regulatory front for the development of antibiotics is backwards. I continue to hope that someone, either within FDA or within congress forces a regulatory reboot for antibiotics.  We need to start over.  And the first premise going forward is that required trial designs must be feasible within the world in which we live.  If this simple concept can be woven throughout our scientific considerations, I am sure that those in industry still left working on antibiotics will respond.  But if we don’t figure this out soon, we risk further losses in this very shaky area within the pharmaceutical industry.

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