FDA Tries To Break Precedent, Pull Unproven Blood Pressure Drug

The Food and Drug Administration is moving to pull ProAmatine, a blood pressure medication that’s been available for 14 years and racked up a quarter billion in sales, because the manufacturer hasn’t submitted a follow-up study that proves the drug is effective.

The FDA sent a letter to Shire Laboratories Monday proposing it pull its drug from shelves and telling the company it can schedule a hearing to plead its case.

What’s odd, according to an AP report, is that the Government Accountability Office says the FDA has never threatened to pull a drug because of an unimpressive or nonexistent follow-up study. Of all such studies the FDA has requested since 1992, only 64 percent have been completed.

Either Shire has terrible luck or this could be the sign of some new FDA consumer protection vigilance.

FDA moves to withdraw unproven blood pressure drug [AP via Yahoo News]
(Thanks, JB!)

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  1. FrugalFreak says:

    OK, who forgot the kickback?

    • azntg says:

      My thoughts exactly.

    • Ximoxion says:

      This is simple. The FDA is now going through all the medications that the new healthcare will have to pay for and is removing the expensive drugs that don’t provide a huge boost to save money. It is that simple. Call it a death panel if you wish, but the truth is that the federal government, who will be purchasing quite a bit of pharma products in the future, is clearing the way for the money to be spent on proven, less expensive drugs.

      • SkokieGuy says:

        Except for the fact that the “new” healthcare requires you to use insurance companies, just like now. The government is not paying for anything, other than the medicare / medicaid / veteran’s benefits it always did.

        If we had single-payer healthcare, then yes, the government would collect the premiums and distribute payments to providers.

        But that didn’t even get serious consideration, courtesy of those that invented the term Death Panels.

        • johnva says:

          Some people will be getting subsidies, so in theory this comparative effectiveness research WOULD save the government money.

    • Bort says:

      could be a competitor kickback

  2. chaesar says:

    smell that? I hope that smell is government accountability and not bull$hit

  3. two_handed_economist says:

    When does the FDA have to submit the study that proves its own so-called
    “approval process” is effective?

    • mythago says:

      Right after the legislation gets changed to require it. I mean, you care about what the law says, yeah?

    • Chaosium says:

      “When does the FDA have to submit the study that proves its own so-called
      “approval process” is effective?”

      Yeah right, and your proposed libertarian “certifying body” would be so much better. It’s certified by a very reliable certifying body!

      • nova3930 says:

        My libertarianish certifying body would ensure that risks were determined and freely available to the doctor and patient. From that point forward, the decision about whether the potential benefits were worth the risk would be up to same said doctor and patient.

        The FDA should have no power to tell us what is and is not safe to use in our own bodies. We own our own bodies and should be able to do with them as our conscience dictates….

        • Briana says:

          This is not about safety, but efficacy. There are no concerns over the safety of the drug. The FDA is taking it off the market because the maker has not provided documentation to show that it is effective. That is something that should be left between the doctor and the patient, provided the drug is safe.

          • ktetch says:

            You do know about the requirements to sell something as a drug, right? It has to treat a medical condition. It’s it’s not treating it, then it’s chemical candy, and shouldn’t be certified as a pharmaceutical.

            I would also love to know how many General Practitioners are educated and experianced in pharmocology, which is what your plan requires.

        • mythago says:

          And when the risks are not “freely available” because the drug company lied or concealed the severity of the risks, well, screw them. It’s their own fault for being sick.

          • kujospam says:

            Or it just stops doing it. They can just say, Prove it did it to you. Run a large scale study costing billions of dollars. LOL They will always win. Unless if people put a gun to their head. Thats why I would rather have the government do it. Much more friendly.

  4. Itismemc says:

    Drugs been out 15 years….. it’s generic…… less money….. people not getting the new shiny drugs….. Big Pharma does it’s research…… leans on FDA ….. competition out of the way!

    • Briana says:

      There is no “new shiny drugs” because this is literally the ONLY DRUG AVAILABLE to treat hypotension.

      That logic doesn’t hold up.

      • SolidSquid says:

        Apparently though it *doesn’t* treat hypotension, or at least they haven’t provided any evidence that it does

  5. BuyerOfGoods3 says:

    Seeing as how my grandmother is slowly dying due to the Heart deterioration caused by Avandia — I was pleased to read this article. Yet, I hold no hope for any future major policy changes in the Pharma-Industry. Profit is for companies, drug traffickers or not.

    • Briana says:

      This situation is not related to your Grandmother’s. This drug is not being pulled due to safety issues. It is being pulled because a bureaucratic requirement was not met.

      • eccsame says:

        She was pleased to see pharma getting a spanking due, in part, to her grandmother’s situation and not attempting to establish a correlation between the two situations. Comprehension reading not you good at.

        • Briana says:

          My reading comprehension is just fine. So how does losing my ability to stand upright, keep my job, and function normally in society make up for her grandmother’s situation again?

      • mythago says:

        And by “bureaucratic requirement”, you mean “safety regulation that was a condition of selling this drug in the first place”.

        Buyer, so sorry to hear about your grandma.

        • Briana says:

          >>And by “bureaucratic requirement”, you mean “safety regulation that was a condition of selling this drug in the first place”.

          No, not a safety regulation. Did anyone RTFA? They failed to file a report on its efficacy, not safety.

  6. mythago says:

    Cue whining from PHRMA about how the FDA has never enforced this much before and so they shouldn’t be allowed to do it ever again.

  7. AllanG54 says:

    Hell, I’ve been on blood pressure meds for 6 years and never heard of that stuff.

    • sugarplum says:

      Maybe you take meds for high blood pressure? This is for low blood pressure, which is a more rare health issue.

  8. sugarplum says:

    Sadly, this medication has been beneficial to me for the past 2.5 years. I’m very anxious about it being removed from market as, for me, it does improve my quality of life. I wish I knew why it was the first medication to be targeted because I don’t really have an alternative to it!

    Someone I am an acquaintance with provided the following information, which I verified.

    “Midodrine is currently the only FDA-approved drug for Orthostatic Hypotension. It was approved in 1996 as part of a shorter approval process under the condition that Shire conduct post-approval studies. Midodrine never was a big seller for Shire, and post-approval studies were never conducted.

    The company that benefits from this decision is Chelsea Therapeutics (CHTP). Chelsea is developing Northera (droxidopa) for the treatment of Orthostatic Hypotension, with pivotal phase 3 trial results due in September.”

  9. Briana says:

    As someone who is completely dependent on this medication to function normally on a daily basis, I say with absolutely no melodrama that this is going to be hugely devastating to the patients.

    This medication is to treat low blood pressure (as opposed to high blood pressure, which is what most of the population deals with). I have to take this every three hours if I want to stay upright and cognizant.

    This drug is the ONLY DRUG AVAILABLE to treat hypotension. There is no suitable alternative. Anecdotally, I can state that without this drug, I would not be able to hold down a full time job, or even stand up and walk around for very long. I would be passing out, or just way too fatigued to function.

    The fact that this is being pulled not because of safety reasons but because of bureaucracy just makes it that much more ridiculous.

    Several patients I know have contacted the company and received notice that they will be discontinuing production next month.

    My doctor is filling a 90 day supply for me to tide me over, and they will be carrying out an “acceptance program” for people who depend on it, but I doubt insurance will cover it.

    I am honestly scared for what this is going to mean for me and for patients like me.

    It’s ridiculous. There are no safety problems, and since when should the FDA be concerned with efficacy? If it’s safe, shouldn’t that be between me and my doctor?

    • sugarplum says:

      I agree. It works for me – it’s pretty easy to show this with a blood pressure test with and without ProAmatine/Midodrine in the system! And I can stand up longer. Why aren’t they contacting some of us users for studies? It it’s such small usage (100,000 people) it shouldn’t be difficult to contact 5% of them.

      I just hope there is still some available so I can do my 90-day refill in September! I don’t think insurance usually covers drugs that are part of an acceptance program (at least without a fight) and I read the FDA document. It’s a supply/demand issue and it can turn into a lotto for who gets it.

      I just want to know why this is the targeted drug. It’s a small user base, it’s been out for 14 years with no real adverse reactions, and it’s helping people. Why this one?

      • Briana says:

        I have a very easy way to show its effectiveness. We all just go up to the FDA offices and stop taking it and show them what happens in 3 hours.

        • Geotpf says:

          I am sure there are ways for the public to comment about this to the FDA. I recommend you do so immediately (and not just on-line, but with certified letters to everybody).

        • Kitamura says:

          If it’s so effective at what it does, this company should have absolutely no problems producing a report showing it’s effectiveness…

    • mythago says:

      If there are no safety problems, then why didn’t Shire Laboratories submit the freaking study like it was supposed to? It’s just paperwork, right?

      I don’t mean to sound harsh, because I think your situation truly sucks and it’s unfair that you’re caught in the middle. But this isn’t an issue of the company submitting a form on a pink sheet instead of a yellow sheet. The FDA has been letting companies get drugs to market faster on the condition that they promise to follow up and report.

    • SolidSquid says:

      If the drug is effective as you say (which it might well be), then it seems likely that the FDA will agree to delay pulling it on the condition that they run the study they agreed to when they were originally given the thumbs up (and if it’s the only one on the market, the FDA is likely to be willing to go ahead)

  10. Briana says:

    Some basic facts that I think should be reported along with this story, since many people do not have context for this particular medical issue:

    1) There are no indications that ProAmatine/Midodrine is unsafe. The FDA is not pulling this because of safety issues, but because paperwork wasn’t filed. The makers decided it just wasn’t worth the effort.

    2) This drug is the ONLY ONE AVAILABLE to treat this condition, and this condition SERIOUSLY affects patient’s ability to function normally. Being able to stand up without passing out is kind of a nice thing. There are no alternative treatments, nothing to fall back on.

    This drug has a gigantic benefit to those taking it, and almost no disadvantages. The reality is that many of us may now have to face losing our jobs, our hobbies, our ability to take care of our families, and our independence. All because the FDA decided to enforce something that seems unnecessary (policing efficacy instead of just focusing on safety) and the company decided it wasn’t worth the impact to the bottom line to cut through this red tape.

    • Master Medic: Now with more Haldol says:

      The truly unfortunate part is that with the new FDA licensing regulations the Pharma companies now must apply for (read pay for) FDA approval for every med in every dose. So Shire makes ProAmatine in multiple doses, they may just be trying to limit the millions to be paid for FDA licensing for each dose level.

      In the EMS world we are struggling to find common meds we use daily because many are low profit producers so the pharma’s make them more as a benefit; not so much for the money. And it’s gonna get worse too when the Obama-Care program reimburses meds at lower rates, pharma’s will just discontinue many effective drugs.

    • Aesteval says:

      I very much sympathize with your position and situation, but I have to ever so slightly disagree on the primary issue at hand. I very much dislike bureaucracy, but I do not see this as an issue of bureaucracy. Efficacy studies, to me, seem to be a reasonable request to make. I think it’s absolutely ridiculous that the FDA “never bothered” to pursue them in the past and also think that maybe they could pick a better way to start, but I definitely see the bigger issue in this case is that the maker has made a conscious decision to outright shaft everyone that’s been providing them with income for the medication over the past 15 years.

      Anyway, I do agree with the person that said you should make as much noise as you can over it. Is there any requirement that the maker of the drug has to be the provider of the efficacy study? Maybe there’s a med school somewhere that would want to use it as a hands on research learning experience for its students. Of course I’d also personally like to see Shire be banned from taking advantage of someone else running a study that they couldn’t be bothered with.

    • mythago says:

      The makers decided it was worth the effort when they marketed the drug in the first place.

    • Conformist138 says:

      I hate that they’re doing this, but what I hate more is the company making your drug. They knew people depended on it, they knew there were no other options, and they chose for 14 years to “not bother” with research studies that backed up any of their claims (which seems retarded, since the comments suggest it works wonderfully). Now, the penalty they already knew existed for not doing these studies is being enforced and the company doesn’t care. So, don’t blame the FDA, blame the assholes really responsible.

      Policing efficiency is not AS important as safety, but it is important. Just look at the stupid homeopathic bullshit, we all know it doesn’t do shit and that it’s a scam. We know people can let serious illnesses progress by wasting their time with quackery. So, if a company refuses to show that their billion-dollar drug actually DOES something after 14 years, I understand why that raises a lot of flags.

      The FDA made an unfortunate first choice with this target, but yelling at them about how they should be ignoring the rules that were put in place in the beginning is just short-sighted. Really, the control of the drug should be taken from this company and sold to someone else. Things like drugs that are required for people to function shouldn’t be left up to market forces or supply and demand.

  11. Bladerunner says:

    I wonder if this is actually just intended to be a kick in the pants…like, the FDA picked a drug that is the ONLY ONE in its class, so therefore is VERY LIKELY to pass (I would think it would have been obvious awhile ago if it didn’t work, especially for orthostatic hypOtension) a test. Iwonder if they’re tryign to say “hey guys, you need to start really doing these,” but rather than A. have the company pull it because they know it doesn’t work but never admit it, or B have a long drawn out fight from one of the big pharmas, they wanted to pick a little fight that they think the comp will win. That way they make their point and nobody loses, except the stressed out patients who think it’ll be pulled.

    Or maybe not. I may be giving them more credit than they deserve.

    • Briana says:

      The company has already stated that it is going to pull the medication. Several of us have contacted Shire directly and have been informed that they are going to discontinue production beginning next month.

      • Briana says:

        IOW, it looks like everyone is going to lose on this one.

        • Bladerunner says:

          Fair enough. That sucks. There’s always Mexico! (Which is sad but). Have you tried Regonol?

          • sugarplum says:

            I was told since Shire is stopping the manufacturing of this drug next month, then likely the generic will follow (as generic companies don’t do drug studies). So availability on the worldwide market could be affected.

  12. SadafImp says:

    Don’t take any drugs if you care to live without side effects.

  13. Master Medic: Now with more Haldol says:

    There are a lot of different drugs in the vassopresser category to choose from. Each have their pros/cons as to exactly what the underlying reason for the hypo-tension and the most effective method of treating it. However, knowing that many people I come across that use this med would otherwise be on the verge of cardiac failure, I would bet that the pharma is just maneuvering to modify this med so as to return it to a non-generic status.

    • jilly9 says:

      Midodrine is the only drug approved for orthostatic hypotension, and it has no central nervous system side affects.

      A lot of people who take this (incl. me) have postural differences in BP – standing/vs laying down.

  14. RxDude says:

    A few points:

    1. “a quarter billion in sales” does not even come close to the cost of getting a drug to market.

    2. A drug must be shown to be BOTH safe AND efficacious (it has to work for the indication sought) to gain FDA approval to be marketed in the US.

    3. The FDA is throwing a hissy fit that they did not get post-marketing studies that were supposed to make up for screw-ups resulting from the accelerated approval process instituted in the 90′s (like Vioxx and Trovan).

    4. The FDA is taking this action in the ABSENCE of evidence of harmful effects of midodrine that did not show up in pre-marketing trials. Many drugs have had additional warnings added after approval, and remain on the market (Accutane, fluoroquinolone antibiotics, SSRIs, etc).

    I would not be at all surprised to see a new drug from a different company marketed for the same indication in the near future. Of course, it would not be available as a generic for quite some time.

  15. philcolby says:

    This could be very bad. Midodrine is a classic drug used by many cardiologists to treat orthostatic hypotension, neurocardiogenic syncope, and a number of other dysautonomic syndromes. Many patients find that they cannot function without the medication. There are no real safe oral vasopressor alternatives. I have a number of patients who I have prescribed the medication to when other agents have failed, with moderate success.

    Hopefully this is more of a scare tactic to get the company to enact a post-marketing registry. But not knowing this company (I never bothered to figure out who made midodrine), I have no idea if they have the millions of dollars in resources necessary to pull off this study.

  16. philcolby says:

    This could be very bad. Midodrine is a classic drug used by many cardiologists to treat orthostatic hypotension, neurocardiogenic syncope, and a number of other dysautonomic syndromes. Many patients find that they cannot function without the medication. There are no real safe oral vasopressor alternatives. I have a number of patients who I have prescribed the medication to when other agents have failed, with moderate success.

    Hopefully this is more of a scare tactic to get the company to enact a post-marketing registry. But not knowing this company (I never bothered to figure out who made midodrine), I have no idea if they have the millions of dollars in resources necessary to pull off this study.

    • sugarplum says:

      Unfortunately, Shire is pulling the drug in September 2010. They don’t want to do the studies…even though know people depend on this medication. It is not a good situation at all. What would make more sense is the FDA forcing them to do the studies/prove it works (which should not be difficult!) instead of letting them just pull the plug on medication many need to function.

  17. Levk says:

    Oh wow that was fast 14 years? man thats way better then the 20 year ones or the others >> they are getting faster I give em credit :)

  18. coffeeculture says:

    I HATE when articles don’t list the generic name of this drug….I was like “what the hell is ProAmatine?” as I’ve never heard it called that way. Had to google it to find out it was just plain ol’ midodrine. Failure in AP reporting.

  19. Warren - aka The Piddler on the Roof says:

    I guess the company releasing the drug didn’t make a large enough ‘donation’ to the FDA.

  20. polymergirl says:

    The problem with post market studies is that they are incredibly expensive. If a drug isn’t a big seller, it is not worth the money and investment from the company. Just getting a drug through the FDA is so expensive and time consuming that only big companies can afford it. The post-market follow up can be too much of a burden.

  21. jilly9 says:

    The FDA has changed their mind, according to the NY Times – “F.D.A. Backtracks and Returns Drug to Market.”