Makena hits the market and it’s a show down at the OK corral

March 21rst. Today is the day that Makena, KV pharmaceuticals “brand” of 17 alpha-hydroxyprogesterone caproate (17OP) hits the market. It’s not really a brand name drug. It has been used for a variety of indications in pregnancy since the 1950′s and you and I, well, we paid for the research via our tax contributions to the NIH.

KV Pharmaceuticals, in a nifty little shell game of a business decision went after orphan drug status, supported by the March of Dimes (MOD). I have blogged here previously about how that shows a complete naivete on the part of the MOD. I know KV Pharmaceuticals has donated to the MOD and I’d like to think that had nothing to do with their support of KV Pharmaceuticals application. Then a again, drug companies can’t give me pens with their logs anymore because that might influence my prescribing…

Today is also the day OB/GYNs, compounding pharmacies, patients, and concerned citizens are taking a stand. According to Dr. Eli Reshef, four OB/GYNs in OKlahoma have banded together to keep Oklahoma Makena-free. They spoke with several compounding pharmacies who are not intimidated by the recent letter from KV Pharmaceuticals. Today Dr. Reshef and his three colleagues (Drs. Stone, Cox, and Hager) are e-mailing and faxing a letter to the OB/GYNs of Oklahoma imploring them to not prescribe Makena and to stay with compounded 17OP (the pharmacies they spoke with felt they could continue to compound). They are following up with personal phone calls to as many docs as they can.

Is this legal? Orphan drug means that no one else can manufacture or market the drug. Compounding pharmacies don’t market, they fill a prescription, and they don’t manufacture, they make small batches. The difference is, does the pharmacy make the product in advance and have it waiting on your shelves for patients (not allowed) or do you fill it one dose at a time after you get the prescription (many interpret this to be allowed).

Many compounding pharmacists have stated they will continue to make Makena. The president of the International Academy of Compounding Pharmacists and the American College of OB/GYN have issued statements saying they believe continued compounding with a doctor’s prescription to be legal. There is precedent. Abbott makes Prometrium®, which is oral micronized progesterone. However, compounded oral micronized progesterone was available before Abbott got the drug FDA-approved, and it is still available. No lawsuits. No FDA action.

What about colchicine and Colcrys® (the “brand”). Colchicine was manufactured by generic companies for years, even thought it wasn’t technically a generic, because it had never been FDA approved. URL Pharma swooped in, got FDA approval, and now they sell what was once a 99 cent tablet for close to $5. The generic manufacturers of colchicine had to stop because they were doing exactly that, manufacturing the drug in quantity. They were not mixing up bulk powder one dose at a time in response to a prescription.

The particular paragraph in the FDA ruling that pertains to the Makena/17OP situation reads as follows:

Compounding drug products that are commercially available in the Marketplace or that are essentially copies of commercially available FDA-approved drug products. In certain circumstances, it may be appropriate for a pharmacist to compound a small quantity of a drug that is only slightly different than an FDA-approved drug that is commercially available. In these circumstances, the FDA will consider whether there is documentation of the medical need for the particular variation of the compound for the particular patient.

What can you do?

If you think it is egregious that a drug that was once $10 a shot is now $1500 send this blog to everyone you know. Write letters to your politicians. Blog about. Tweet about it. Join the Facebook Fan Page Shame on You KV PHarmaceutical and CEO Greg Divis.

While I think the FDA will do nothing (because then they they have to step in and stop compounding pharmacies from making a lot of other compounded hormones as well), we need to take a stand, just like they are in Oklahoma. We need the FDA to hear our message loud and clear. That the American people are pissed off about the cost of health care and that FDA sanctioned extortion is not OK. Pregnant women, women who are already worried about having another premature baby, are now worried about the cost of 17OP. Some will dig deep and find the extra money for co-payments and others will not.

So today, I am taking a stand with the doctors in OKlahoma. I am taking a stand for premature babies. Join me!

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6 Responses to Makena hits the market and it’s a show down at the OK corral

  1. Jim says:

    Colchicine, previous to FDA approval, cost 9 cents (not 99 cents) so it is an example of a rip off like Makena, albiet not the same magnitude or importance.

  2. Jennifer Gunter says:

    Thanks for catching that typo! Colchicine was 9 cents a pill up to almost $5!

  3. Here is the opening salvo in the fight against price gauging: Oklahoma City’s Channel 9 coverage 3/21/11:

    Please join us, y’all!

  4. goMAKENA says:

    if you approve non-FDA approved drugs to treat preterms, your going to end up with alot of pre terms that would have been otherwise healthy, you are a very uniformed and uneducated about the matter.

    in 9 months the lawsuits that will arise from patients against doctors for not providing a better treatment will teach a very valuable life(long) lesson to these same uninformed people.

  5. Jennifer Gunter says:

    Do you work for Ther-Rx?

    The non FDA approved 17OP has been around since the 1950′s and was the product used in the landmark 2003 NEJM study. There have been no reports of issues. There is level 1 evidence supporting the use of this product and the use of compounded 17OP has been endorsed by ACOG. So, hard to see your point. Women should talk with their own OB/GYN about the product that is best for them.

  6. Deborah Jack says:

    Comparing Makena to Colcrys is not apples to apples. There were many deaths caused by unnaproved colchicine. URL did pay the money to conduct the studies to curb the needless deaths and the labeling will be available forever long after the patent has expired. If you knew the whole story you would see why the FDA took action on colchicine. I am not aware of the studies KV conducted so I can’t comment.

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