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Fixing the Generic Drug Process

It’s very early in Scott Gottlieb’s tenure at the FDA, but I like what he has to say about generic drug approvals. Several times here, I’ve gone on about how a lot of the terrible pricing situations we’re seeing in generics are due to gaming of the regulatory system, and how the FDA could do a lot to keep such things from happening. It looks like Gottleib agrees – he’s told Congress that he would like to:

— “Curtail gaming by industry of our regulations which can extend monopoly periods beyond the time frame Congress intended, hindering competition.”

— “Improve the processes that enable generic versions of complex drugs to be approved for marketing.”

— “Increase the overall efficiency of the generic drug review process while completely eliminating the backlog of generic applications.”

The REMS program (risk evaluation and mitigation strategies), he noted, has been used to slow generic competition, and streamlining the process by waiving the requirement that a generic and brand manufacturer share a single system for assuring safe use could be used to eliminate one tool used to slow generics.

Good. The generic drug system is supposed to provide cheap, readily available drugs that have gone off patent, but it’s turned into a place to game the system in order to jack up prices on old drugs. If Gottlieb can clean that up, more power to him, because it’s giving the entire industry a black eye. Remember, the general public does not distinguish between generic manufacturers and the companies that bring new research-driven drugs to market. We’re all “the drug industry”, and we all look bad when any companies pull these stunts.

13 comments on “Fixing the Generic Drug Process”

  1. anoano says:

    Good luck to him

  2. Bagger Vance says:

    When something’s wrong it’s Trump’s fault; when he picks a decent candidate he’s nowhere to be seen. Got it.

    1. cynical1 says:

      Even a blind squirrel finds a nut once in a while.

      And this squirrel is deaf, blind and dumb as a rock but, unfortunately, certainly not mute.

    2. Hap says:

      He didn’t get drilled for Mattis, either, though he might not be what Democrats/liberals would have picked.

      The problem is that the dud:(competent+good) ratio for his Cabinet picks is…not low. Picking competent or good people consistently would be the measure of a President’s competence, and unfortunately Mattis and Gottlieb appear to be the exceptions, not the rule.

    3. Derek Lowe says:

      Compared to some of the names that were floating around, Gottleib is indeed a relief. And I have no problem with Gorsuch being on the Supreme Court. The problem is, I see these appointments as outliers to the general Trump circus. “Who knew health care could be so complicated?”

      1. 🇺🇸 🇺🇸 🗽 🗽 says:

        ❄ ❄ ❄️❄️❄️❄️❄️❄️❄️

      2. Hap says:

        Gorsuch wasn’t that bad – the Dems were steamed because they got denied the right to select their own replacement, but he was an actual competent and qualified candidate, as opposed to Robert Bork (like making a creationist the head of the American Society for Biochemistry and Molecular Biology) or Harriet Miers. Unfortunately, more of Trump’s picks have looked like Miers than Gorsuch.

  3. Emjeff says:

    Good luck – but the entrenched bureaucracy at the OGD has a vested interest in keeping things slow and inefficient, so I predict this will go nowhere…

  4. Processed chemist says:

    Who cares? With the invention of all these flow-bots everyone can just ask Alexa to cook up their pills on demand. 💊 🤖

    1. Me says:

      That will only work until flowbots are banned because you can make meth with them. It isn’t a long-term solution. 😉

      1. Chris Phoenix says:

        I think by the time that happens, people will have figured out how to make flowbots out of laser-cut plastic. You can glue together a fluidic stack that feeds materials from ports through very narrow channels which can join and branch. Laser cutters are only a few thousand dollars now.

  5. Ann O'Nymous says:

    Dr Lowe I fear you are falling into the trap of liking a policy aspiration and not a policy. I think we can all agree on the aims, and the text you cited above is heavy on the aspirational verbs, like “improve” and “increase”. The challenge is how to convert that into policy, in other words, how is this going to work?

  6. Anonymoose says:

    I’m sorry, but an FDA director who believes the FDA shouldn’t be in the business of regulating efficacy is just another one of Trump’s poisonous swamp creatures.

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