Can 17 hydroxyprogesterone still be compounded? Yes it can!

The recent uproar over KV Pharmaceutical’s pricing of Makena, 17 alpha-hydoxyprogesterone caproate or 17OP for preterm labor, has left many wondering if Makena (and it’s $1,500 per shot/$30k per pregnancy price tage) can simply be avoided  and pregnant women continue to get 17OP from compounding pharmacies (at the very reasonable $10 or so a shot).

The answer is yes. Compounding pharamcies are STILL an option.

Even though KV Pharamceuticals has sent warning letters to compounding pharmacies, in reality there is nothing they can do about any pharmacy who continues to compound 17OP. That is because KV doesn’t have a patent on the actual hormone itself. What they have is orphan drug status, which gives them the right to exclusively manufacturer and market the product for seven years. They may patent their specific formulation, but compounding pharamcies have their own recipes.

Compounding pharmacies each having their own recipe was the supposed reason the March of Dimes jumped on board the Makena bandwagon. In theory, it is better to have a drug made uniformly with standardized testing for purity, potency, etc. For example, if 17OP were less effective for women in one part of the country, without a uniformly manufactured drug it would be hard to know if the problem were patient demogrpahics, other issues related to medical care, or the fact that the 17OP all came from one compounding pharmacy that maybe wasn’t as good as another pharmacy down the road.

Although that being said, there have been no reports of compounding issues/lack of efficacy with compounded 17OP. None.

The law says a compounding pharamcy can mix up any FDA approved/legal drug or hormone. Since compounding 17OP is not patent infringement, KV Pharamceuticals is poweless to do anything. Having ophan drug status doesn’t help much either, because the compounding pharamcies are not marketing the drug, they are filling a physician’s prescription. They are also not manufacturing it, they are filling prescriptions one or two at a time.    

The ONLY way KV Pharamceuticals can stop the compounding of 17OP is to go to after the source manufacturers of the bulk 17OP powder and convince them to stop selling to compounding pharmacies. There are several companies that make 17OP bulk powder, so that scenario is unlikely to unfold.  

The only one who can actually stop the compounding pharmacies is the FDA. Considering all the pharmacies that already compund tons of hormones, some with nebulous indications and even potentially dangerous side effects (testosterone and your 1% risk of breast cancer a year for women, I’m looking squarely at you), there is no way the FDA can go after pharamcies for mixing up a drug that has been proven to be effective and recommended by the American Congress of OB/GYN.

So to the pharmacies I say, “Compound away!”

And as my friend Dr. Nicholas Fogelson suggests, OB/GYNs should boycott KV Pharamceuticals and Makena and keep supportng their local compounding pharamacies.

KV Pharmaceuticals should not be allowed to line their coporate coffers (to the tune of $4 billion/yr) at the expense of premature babies.

Just say no to Makena. We have the power to stop this.

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8 Responses to Can 17 hydroxyprogesterone still be compounded? Yes it can!

  1. This seems to force the question: Why did KV Pharma pursue orphan drug status?
    - Do they think they have an endgame to edge out the compounding pharmacies?
    - Do they just plan on marketing the compounding pharmacies out of business?
    - Would insurance companies see the compounding pharmacies’ product as a generic equivalent?
    It seems that most insurers would not include Makena as part of their formulary and would force the hand of OBs to prescribe the cheaper product made by the compounding pharmacies.

  2. Max Kennerly says:

    I wish that was true, but it’s not.

    Federal law (specifically, 21 U.S.C. § 353a(b)(1)(D)) expressly precludes compounding pharmacies from “compound[ing] regularly … any drug products that are essentially copies of a commercially available.” There’s an exception if a prescribing physician asks for a compound with different active compounds (21 U.S.C. § 353a(b)(2)), but that’s not really possible to pull off with 17P.

    As Joanne Armstrong, chief of women’s health at Aetna, wrote in the New England Journal of Medicine: “Under these [FDA] regulations, production of compounded 17OHP which ‘copies, or essentially copies’ Makena must cease.”
    See: http://healthpolicyandreform.nejm.org/?p=13971

  3. Malie says:

    I hope you are right, but my understanding of the law is exactly the opposite of your description above. What are your sources for your legal interpretations? The FDA will likely go after the unapproved compounded drugs (as they did with colchicine in 2010), and I doubt many pharmacies will put up a fight because the active ingredient in the compounded drugs and Makena is the same. Joanne Armstrong (senior medical director at Aetna) discusses this in her article too, and she said: “Furthermore, when the FDA approves new, commercially available drugs, compounded drugs that are copies, or essentially copies, of such drugs must stop being produced. Under these regulations, production of compounded 17OHP which “copies, or essentially copies” Makena must cease. The FDA will make the determination of whether a compounded formulation of 17OHP is a copy of Makena. Failure to adhere to the FDA’s determination may result in sanctions.”

  4. Jennifer Gunter says:

    The press release from ACOG today, March 18, says, “America’s Pharmacists are defending women’s access to hydroxyprogesterone caproate. Citing a KV investor briefing documents showing that Makena has a gross profit margin of 97.5%, the pharmacy association is calling KV Pharmaceuticals’ February 2011 letter which warned pharmacies to stop compounding the product little more than a “scare tactic.” The organization emphasized to its members that pharmacists can legally compound FDA approved products when a prescriber determines that the compounded preparation is more clinically appropriate for an individual patient.”

    Jennifer

  5. Malie says:

    I really do hope you’re right. But it concerns me that compounding pharmacies will be changing the “recipe” in an attempt to get around the statute and regulations. The FDA may crack down on what it sees as adulterations of FDA-approved drugs. I’m also concerned that there is a movement to encourage OBs to prescribe the non-FDA approved drugs when Makena is now the standard of care due to its FDA approval and testing. These other formulations are probably safe–I certainly hope so–but it could open up OBs to tort liability for deviating from the standard of care in the event anything goes wrong. I wish the best of luck to everyone fighting Makena. I hope this fight doesn’t lead to unintended liability for the good guys.

  6. Pingback: Can the March of Dimes win back our trust after the Makena debacle? | Nowhere Special

  7. Melissa says:

    Makena is made with Castor Oil and some compounding pharmacies use Sesame Oil, with that in mind those compounding pharmacies using Sesame Oil have a different product that Makena.

  8. Pingback: Rep. Henry Waxman demands answers from Ther-Rx about Makena | The Preemie Primer Guide from Dr. Jen Gunter

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