Makena Drama: I Will Never Escape

It almost makes me sick to be dealing with this yet again. I confirmed with my doctor's office that the FDA was allowing compounders to create 17P (hydroxyprogesterone caproate), and asked my CVS/Caremark pharmacy not to send me another $100 (copay) refill for the last 5 shots of Makena. After all, why spend $100 (and let my insurance pay KV Pharmaceutical) when my compounding pharmacy could produce the same drug and make a profit with just me paying them about $35 for the same amount?

I have had a bit of a cold, so I put off calling my local specialty pharmacy until Friday, thinking they could get the drug to me by Tuesday, when my 32-week shot is due. Last time they filled the scrip it was the same day I brought in the order. The pharmacy rep told me that they could no longer compound 17P. "Aha!" I said, "but the FDA reversed that decision, and now compounding pharmacies can make 17P!" Seriously, am I the only person in Colorado on this drug? And then the other government issue shoe fell.

She told me that the Colorado Board of Pharmacy would not allow them to compound it. I looked up the board—it's the state pharmacy licensing agency, responsible for (a) licensing, and (b) enforcing laws through licensing, not licensing, revoking licenses, etc. They're not a legislative agency, so I was confused as to how they'd have anything to do with me and my 17P. Naturally, since I have nothing better to do, I called the state professional licensing organization and they connected me to a very nice man at the Pharmacy Board.

He directed me to the Colorado Revised Statutes (i.e. Colorado legislation), namely CRS 12-22-121(18)(c):

(I) A prescription drug outlet shall not compound drugs that are commercially available except as provided in subparagraph (II) of this paragraph (c).
(II) A pharmacist may compound a commercially available drug if the compounded drug is significantly different from the commercially available drug or if use of the compounded drug is in the best medical interest of the patient, based upon the practitioner's drug order, including, without limitation, the removal of a dye that causes an allergic reaction. If a drug is compounded in lieu of a commercially available product, the patient shall be notified of the fact.

Translation: unless I'm allergic to the commercially available form, I HAVE to buy it.

It's really not a bad law. It's made to protect manufacturers from compounding pharmacies simply stealing away business by making whatever drugs they want. When you look at the way most drugs go through the processes of creation, approval, patenting, going generic, etc., it makes total sense. This whole Makena thing is just so F'd up that the only way for the commercial drug to have competition was through compounders, since no other commercial options are available. The drug is over 50 years old!

The problem stems from KV Pharmaceutical "developing" a drug that already existed, and from the FDA's promise of orphan drug status that would give them a monopoly. Orphan drug status, of course, only goes to drugs that affect a small number of people. Thanks, FDA, for screwing those of us in the minority with the "rare" problem of preterm labor. At least they shaped up in the end, but unfortunately I am still screwed into getting another rush order of the expensive stuff.

I'm going to say that if KV couldn't make the drug at a competitive price, they shouldn't have made it in the first place.

I continue to be baffled by the high price of Makena. I get the difference between the compounded version of hydroxyprogesterone and the commercial version: KV Pharmaceutical is mass producing the drug, ensuring that dosing standards are met exactly, and regulating the quality of the drug. Mass production is usually a cost-saving measure. It's because of mass production that factory-made items are less expensive than hand-made items. Efficiency cuts costs.

But what if mass production isn't efficient and doesn't cut costs? The high price of Makena is a result of one or both of two things: price gouging because Makena had the "orphan drug" monopoly that eliminated competition, or high production costs, meaning Makena is produced less efficiently than at compounding pharmacies. If it's so expensive solely because of inefficiency of production, then we need to look at whether the dosing and quality regulation they do is really worth the added expense over the dosing and quality control individual compounders do. Certainly compounders are held accountable for any mistakes, as was made clear when the FDA began to allow compounding pharmacies to compete with Makena again so that women could get this important drug. Essentially they said that though they'd allow pharmacies to compound the "orphan drug" without punishment, these individual pharmacies would still be held accountable for the safety, quality, and sterility of their products. I don't know about you, but I trust a smaller local firm with a lot to lose over a giant pharmaceutical company that has a lot more resources and power to fight or hide anything substandard in their product.

So the benefits offered by Makena, in all its commercial glory, have debatable value. No, since the FDA seems to think the commercial production is valuable, I'll say they have definite value. But shouldn't the consumer be able to decide how much value? Can't I say how much mass production and standardization is worth to me? It's not worth as much as Makena costs, that's for sure. And now laws that were made to protect both consumers and drug companies from knockoff drugs are keeping me, yet again, from getting the meds I need at a fair price.