21 votes

Amid backlash, US FDA changes course over shortage of weight-loss drugs

18 comments

  1. [16]
    tanglisha
    Link
    I wonder how much of the shortage would still exist if they sold the one use injector pen medications in vials instead. Ozempic has a fantastic dial-a-dose pen, but the others are an entire pen...

    I wonder how much of the shortage would still exist if they sold the one use injector pen medications in vials instead. Ozempic has a fantastic dial-a-dose pen, but the others are an entire pen that gives the stated dose, then you have to figure out how to dispose of the ridiculous thing.

    It’s almost impossible to get insurance coverage for these and yet the demand is this high. I don’t think any of the public health folks have taken a hard look at this.

    13 votes
    1. [10]
      OBLIVIATER
      Link Parent
      Trying to get restricted prescriptions for a lot of stuff is a huge PIA right now. I've had to pay 5x more than normal for my Vyvanse for the last 6 months because generic is just completely out...

      Trying to get restricted prescriptions for a lot of stuff is a huge PIA right now. I've had to pay 5x more than normal for my Vyvanse for the last 6 months because generic is just completely out of stock everywhere and my insurance doesn't like covering the brand name stuff.

      11 votes
      1. [9]
        RheingoldRiver
        Link Parent
        if insurance won't cover X because they think Y should suffice, they should be required to provide you with Y for the same value as you'd pay at a normal pharmacy

        if insurance won't cover X because they think Y should suffice, they should be required to provide you with Y for the same value as you'd pay at a normal pharmacy

        10 votes
        1. [8]
          WiseassWolfOfYoitsu
          Link Parent
          Vyvanse in particular is problematic due to systemic supply shortages at the moment. I have had months I couldn't get it even offering to pay full price for the name brand. The problem with it is...

          Vyvanse in particular is problematic due to systemic supply shortages at the moment. I have had months I couldn't get it even offering to pay full price for the name brand. The problem with it is that the FDA decided too many people were abusing it and set a nationwide production limit of one of the core ingredients, with no flexibility to handle problems or changes. So one of the generic manufacturers has a problem? Market just loses that chunk of production since it can't be reassigned. Predictions wrong? Well, hope we get it better in 18 months when we re-assess! Abusers still get it but people with ADHD don't because it's become so difficult to get a hold of that the people with ADHD can't handle the extra level of monthly effort but abusers can? Sounds like a you problem!

          (Yes, I am a bit bitter over the last year and a half of getting jerked around like a yoyo on important medication, how can you tell?)

          13 votes
          1. [3]
            steezyaspie
            Link Parent
            I believe the problem here is the DEA’s production limits, not the FDA. The FDA regulates what pharmaceuticals are approved for sale and how they are produced, the DEA sets limits on how much is...

            I believe the problem here is the DEA’s production limits, not the FDA. The FDA regulates what pharmaceuticals are approved for sale and how they are produced, the DEA sets limits on how much is able to be produced.

            18 votes
            1. Akir
              Link Parent
              It is truly astonishing to see the extent the war on drugs has damaged the society of people in the United States. When I learned about this I was indescribably pissed. I don’t take those kinds of...

              It is truly astonishing to see the extent the war on drugs has damaged the society of people in the United States. When I learned about this I was indescribably pissed. I don’t take those kinds of medications but it’s self-evident that this policy does much more harm than good.

              11 votes
          2. [2]
            RheingoldRiver
            Link Parent
            ah yes, controlling substance use has worked so well and effectively in the past

            ah yes, controlling substance use has worked so well and effectively in the past

            3 votes
            1. Habituallytired
              Link Parent
              yuuup. I've been struggling with the Adderall shortage. I feel everyone with ADHD who's struggling with getting their meds. It's also an extra layer of fun for me because I take 3 different...

              yuuup. I've been struggling with the Adderall shortage. I feel everyone with ADHD who's struggling with getting their meds.

              It's also an extra layer of fun for me because I take 3 different controlled substances (for chronic illnesses/autoimmune issues), and Wegovy, which my insurance decided it no longer wants to cover, after I already got an exception, so I've been fighting with insurance to make them continue to cover it until I can meet with my doctor to get off of it, since going off of the highest dose cold-turkey can have some severe GI issues.

              Controlling the meds people legitimately need is awful, and I wish the government would go after the insurance companies for causing these issues instead.

              2 votes
          3. GreasyGoose
            Link Parent
            Ironically, this is similar to Concerta that I’ve been approved for re: a Tier Exception. The generic is Tier 1 with my insurance while Concerta is Tier 3. Basically I had to get approval to use...

            Ironically, this is similar to Concerta that I’ve been approved for re: a Tier Exception. The generic is Tier 1 with my insurance while Concerta is Tier 3. Basically I had to get approval to use the name brand at generic cost after a few repeated attempts.

            The kicker? I can definitely get my hands on it since it’s so expensive at almost $500 on GoodRX. I guess while drug companies will have generics, they can still hold patents to other parts such as release mechanisms.

            Concerta’s release mechanism is what makes it so expensive and something that generic versions don’t have, making it rather ineffective.

            2 votes
          4. public
            Link Parent
            Perhaps it's time to switch to Walter White pure blue stims.

            Perhaps it's time to switch to Walter White pure blue stims.

            1 vote
    2. [5]
      skybrian
      Link Parent
      The waste is annoying, but I don't think there's a general shortage of injector pens? It seems more likely that it's about the contents than the container.

      The waste is annoying, but I don't think there's a general shortage of injector pens? It seems more likely that it's about the contents than the container.

      8 votes
      1. [3]
        GreasyGoose
        Link Parent
        Looking at the medical subreddits, a decent chunk of MDs have been saying that the pens are more of an issue IIRC.

        Looking at the medical subreddits, a decent chunk of MDs have been saying that the pens are more of an issue IIRC.

        5 votes
        1. [2]
          skybrian
          Link Parent
          Anything good you want to share?

          Anything good you want to share?

          2 votes
          1. GreasyGoose
            Link Parent
            Sorry I should’ve been more specific, in that the pens themselves are a shortage issue, vs the drug itself. Yes, anecdotal but that subreddit seems to police itself rather well....

            Sorry I should’ve been more specific, in that the pens themselves are a shortage issue, vs the drug itself. Yes, anecdotal but that subreddit seems to police itself rather well.

            https://www.reddit.com/r/medicine/comments/1csn5fp/novo_nordisk_begins_a_240_person_study_of_wegovy/l477li6/

            This is one that comes to mind while reviewing a study for AUD. Plugging “wegovy” into search should bring up some others as well.

            1 vote
      2. tanglisha
        (edited )
        Link Parent
        They haven't really specified in anything I've read. They just say it's a shortage.

        They haven't really specified in anything I've read. They just say it's a shortage.

        1 vote
  2. skybrian
    Link
    From the article:

    From the article:

    The recent upheaval began Oct. 2, when the FDA declared the Mounjaro and Zepbound shortage over after almost two years. It provided little detail other than saying that Eli Lilly had shown it could “meet the present and projected national demand,” while acknowledging that patients could still see periodic shortages due in part to the logistics of shipping the refrigerated medication.

    Compounding pharmacies, which custom-make prescriptions, had to abruptly stop. That effectively shut off access to a source estimated to be used by millions of patients, triggering what pharmacists have described as a deluge of calls and text messages from panicked prescribers and patients. […]

    On Oct. 11, the FDA opted against fighting a federal lawsuit brought by compounding pharmacies, saying it would reevaluate whether the drug is available. It also said it would not take enforcement action — for now — against pharmacies making their own versions of weight-loss drugs based on Eli Lilly’s tirzepatide, according to a letter it sent to the Alliance for Pharmacy Compounding on Thursday.

    “The abruptness of FDA’s resolution of the tirzepatide injection shortage left thousands and thousands of patients stranded with a prescription that could no longer be filled — and no speedy means of transitioning to the FDA-approved drug,” Scott Brunner, chief executive of the Alliance for Pharmacy Compounding, said in a statement Friday. He called the FDA’s clarification “wonderful news.”

    The FDA hasn’t responded to requests for comment about why it shifted course so quickly, other than to say that it doesn’t comment on litigation. The agency has said compounded medications in general aren’t as safe as drugs that go through its review.

    Eli Lilly, which has been waging an aggressive legal campaign against compounded medications, said in a statement that “nothing changes the fact that, as FDA has recognized, Mounjaro and Zepbound are available.” The drugmaker added that “it is important that patients not be exposed to the risks in taking untested, unapproved knockoffs.”

    Yet independent pharmacy experts cite reports from patients and prescribers that they have difficulty finding the drugs.

    “It’s obvious that there’s not actually enough out there to meet all the patient demand,” said Michael Ganio, a senior director at the American Society of Health-System Pharmacists, which maintains its own list of drugs in shortage — including tirzepatide.

    He added that the FDA’s reversal reflects the limits of its tools, such as having little historical data to project demand.

    6 votes