• The FDA’s new mission statement

    UPDATE:  The language in question is still [bracketed] text, meaning the House Committee has not agreed yet on the language.  Markup is today (Thursday) starting at 10 am.

    The Prescription Drug User Fee Act (PDUFA) process requires the FDA to meet with drug and device makers and agree on a budget and regulatory agenda every five years (is this a good idea?). This year is the fifth iteration, PDUFA V, a bill which must be passed by summer or else many FDA employees will be furloughed. In other words, this bill will be the only health care bill that will pass before the election.

    PDUFA’s “must pass” status makes it attractive for other legislation to hitch a ride. I posted yesterday about the antibiotic prize study in the Senate draft and previously about antibiotic incentives in the GAIN Act which is included in both the House and Senate versions.

    One of the most fundamental changes is found only in the House bill, in Section 601. Historically, the mission of the FDA has been to protect the public’s health by evaluating the safety and efficacy of drugs and devices. Now, the FDA will also have a mission more suited to the Department of Commerce:

    (B) protects the public health and enables patients to access novel products while promoting economic growth, innovation, competitiveness, and job creation among the industries regulated by this Act; (Section 601, page. 143 of the April 23, 2012 version of the House Bill)

    To anyone who carefully watches prescription drug policy globally, this provision is striking. It tells the FDA that its mission isn’t just safety, but also “promoting economic growth, innovation, competitiveness, and job creation among the industries regulated” by the FDA. In other words, help drug and device companies make more money.

    I can’t imagine a worse idea for the FDA. Period.

    This is a terrible policy change which will dramatically undermine the FDA’s ability to make decisions based only on science and the public’s health.

    h/t to Marie Serebrov, Fierce BioTech/BioWorld Today April 23, 2012 (subscription only)

    @koutterson

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    • Kevin
      GIven the latitude often ascribed to statutory language, could it not be the converse, mainly, the “growth” is to the economy at large, and not the pharma sector. One could postulate that the ROI for a given product does not meet a standard (a black box in itself), and as a result, approval is conditional or denied.

      Gets back to congressional intent. Are you sure that is what both sides of the aisle are thinking, essentially, pump up profits and needless job growth. Or, is this an ideological affair putting forth a penny wise, dollar poor bill? Probably, but i know little about the FDA inside game.

      Brad

      • The text says “promoting economic growth, innovation, competitiveness, and job creation among the industries regulated.” The last 4 words answers your question.
        This bill is being marked up right now. It will pass the House.

    • I disagree with part of your conclusion. The statement calls for: “promoting economic growth, innovation, competitiveness, and job creation among the industries regulated”

      While I agree the FDA shouldn’t be thinking about job creation, promoting innovation should actually be an important element of the FDA’s job.

      You can define safety in terms of deaths prevented from poor pharmaceuticals, but you could also define safety in terms of deaths prevented from all causes. If the FDA is too slow-moving/expensive/prohibitive to allow new drugs to be developed, you are putting the lives that could potentially be helped in danger.

      So sure, strike out economic growth, competitiveness and job growth. But if ALL you work towards is preventing harm through action, you’re bound to harm people who could have been helped by more courageous ideas and therapies.

      • Yes. I agree. There isn’t even an attempt to estimate the lives that are lost because of delay due to caution. Just because numbers are hard to determine doesn’t mean they aren’t REAL.