PDUFA V passes House & Senate, heading to conference committee soon

The House just passed their version of PDUFA V, H.R. 5651, by a vote of 387-5, including new incentives for antibiotics and antifungals.  I’ve commented on the Senate version of this bill (S.3187, passed 96-1) here at TIE and in the APUA Clinical Newsletter.  As I said before, this is the only health care bill that is guaranteed to pass Congress this summer.

What’s the same?

  • 5 years of patent-expiration-proof exclusivity tacked on to the end for “qualified infectious disease products” or QIDPs. House 831; Senate 801.
  • QIDPs are virtually any antibiotic or antifungal drug, without meaningful limitation to serious infections. It is a pathogen-based approach. Almost every antibiotic in the next 5 years will qualify, without regard to the quality of the drug, the novelty of its action, or any other indication of clinical usefulness. This is an unfocused incentive.
  • The FDA is encouraged to weaken clinical trial and approval requirements, to allow more surrogate markers and animal models, and to issue more guidance to drug developers. House 833; Senate 805.
  • Beyond antibiotics, a new “fast track” system to allow potentially important drugs on the market with shorter clinical trials (really, Phase IIB), combined with enhanced FDA authority to withdraw the drug if problems occur. I’ve blogged before about this revolutionary, under-reported change in FDA law. House 841, Senate 901. This should be front-page news.

What’s different in the House bill?

  • The antibiotics prize study and the separate immediate GAO study in the Senate is replaced with a general study after five years on antibiotic incentives. Sec. 834. Why wait five years and exclude prizes? Several of the major companies are interested in antibiotic prizes, so this might change in conference. One part of the GAO study that survives is now limited to biological products. A good idea, as vaccines don’t generate the same types of resistance (but see, serotype replacement), but why not look at other options too?
  • Antibiotic stewardship (conservation) is mentioned, unlike in the Senate, but only for future study, not present action. Sec. 834. For the time being, it is “drill, baby, drill” for more antibiotics without any thought for preserving the useful lives of current drugs.
  • The definition of QIDP is weaker in the House, allowing more antibiotics to qualify without regard to actual impact on human health.

The IDSA was deeply involved in this legislation; they were successful in all of the bullet points above, but did not get any incentives for antibiotic stewardship or conservation. Prior TIE lit review on antibiotic conservation here.
@koutterson

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