This is the saga of K-V Pharmaceuticals’ attempt to extract vast riches from their "Makena" a 54 year old drug also known as progesterone, at our expense. Progesterone has many uses, one of which is to prevent pre-term birth. KV ran some clinical trials and proved to the FDA’s satisfaction that it works for this purpose – no surprise, since doctors have been prescribing it for this for some time. The cost had been a couple or few hundred for a course of treatment. Now KV wants $30,000. Of course, if it remains available from compounding pharmacies at the old price, they won’t get much business. So KV wants to run the compounding pharmacies out of that business.
KV has portrayed this as a done deal, and the press has bought it. Diarists here have repeated it. This is not a done deal. I will explain why. But first, why this is so important….
1. The obvious, part 1: If the insurers agree to pay for this, the people who will really pay for it are we who pay for health insurance. To the extent Medicaid gets stuck with these bills we pay for it with our tax dollars.
2. The obvious, part 2: Uninsured women. If you are suitably poor, KV, out of the goodness of their corporate hearts, say they will provide you treatment at a low cost. Provided you jump through the hoops. And they keep their word.
3. Progesterone has many uses, treating: infertility , irregular menstruation, hypoestrogenism, amenorrhea, symptoms of PMS, menopause & perimenopause, and endometriosis. If KV succeeds in driving compounding pharmacies out of this market, women and their physicians who want measured does of progesterone from a compounding pharmacy for any of these purposes will be out of luck. Anyone you know who is using hormone replacement therapy is most likely getting progesterone from a compounding pharmacy.
Now, why this is not a done deal. Most providers of new FDA approved drugs have patent protection. If anyone else were to try to cut in on their business they would get slapped with a lawsuit and perhaps an injunction. KV has no such patents. In their “cease and desist” letter, KV first cites the U.S. code and a related appellate decision:
the pharmacist or physician compounding the drug may not “compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product.” §353a(b)(1)(D).
This would seem to be on point but for one essential fact: the number of
monthly prescriptions for hormone replacement therapy is in the neighborhood of
4-5 million. Generally speaking these prescriptions include progesterone and come from compounding pharmacies. Makena is not approved for this indication, so for the purposes of this regulation this use does not qualify as a copy of a commercially available product. The
number of preterm births in the US is about .5 million/year. If every one of these women were prescribed progesterone in one form or another, it would only run 10% of the rate of the HRT prescriptions. So KV has no right to run these pharmacies out of business just because they are providing progesterone. As to any restrictions upon providing progesterone for prevention of preterm birth, to the extent any compounding pharmacy might be aware of this intended use, that is up to FDA guidance and enforcement, which we will cover next.
KV then cites FDA regulations Sec. 460.200, regarding Pharmacy Compounding, as the reason for imminent FDA enforcement. Let’s see what this section actually says:
FDA recognizes that pharmacists traditionally have extemporaneously compounded and manipulated reasonable quantities of human drugs upon receipt of a valid prescription for an individually identified patient from a licensed practitioner. This traditional activity is not the subject of this guidance.
This is exactly what the compounding pharmacies are doing when they supply progesterone.
FDA believes that an increasing number of establishments with retail pharmacy licenses are engaged in manufacturing and distributing unapproved new drugs for human use in a manner that is clearly outside the bounds of traditional pharmacy practice and that violates the Act. Such establishments and their activities are the focus of this guidance. Some "pharmacies" that have sought to find shelter under and expand the scope of the exemptions applicable to traditional retail pharmacies have claimed that their manufacturing and distribution practices are only the regular course of the practice of pharmacy. Yet, the practices of many of these entities seem far more consistent with those of drug manufacturers and wholesalers than with those of retail pharmacies. For example, some firms receive and use large quantities of bulk drug substances to manufacture large quantities of unapproved drug products in advance of receiving a valid prescription for them. Moreover, some firms sell to physicians and patients with whom they have only a remote professional relationship. Pharmacies engaged in activities analogous to manufacturing and distributing drugs for human use may be held to the same provisions of the Act as manufacturers.
This is not at all what the compounding pharmacies we are concerned with are doing
…. when the scope and nature of a pharmacy's activities raise the kinds of concerns normally associated with a drug manufacturer and result in significant violations of the new drug, adulteration, or misbranding provisions of the Act, FDA has determined that it should seriously consider enforcement action.
So, as written, these FDA regulations are clearly inapplicable to the matter at hand. Nonetheless, we can presume that KV is heavily lobbying the FDA to see things their way.
Given the amount of negative attention this matter has received lately one would hope the FDA would refrain from cutting off alternate sources of supply. Perhaps someone experienced with FDA enforcement practice could comment.
Next, many have already taken KV at their word without checking the law and FDA regulations. It is possible coumpounding pharmacies may do the same.
Action item: Anyone here who has dealings with a compounding pharmacy is requested to inquire whether they intend to continue providing progesterone. If not, ask to talk to the decision maker and explain that progesterone provided for HRT is clearly not subject to any restrictions, and that any enforcement is the province of the FDA only.
If you see fit, please recommend this diary to get this matter suitable attention.
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Updates:
Senators call for investigation into KV drug
U.S. Sens. Amy Klobuchar, D-Minn., and Sherrod Brown, D-Ohio, are calling for an investigation into what they call price gouging and potentially anti-competitive behavior after KV Pharmaceutical raised the price 150-fold for an injection used to prevent preemie babies.
The lawmakers sent a letter Thursday to Federal Trade Commission Chairman Jon Leibowitz urging the agency to launch a probe into Makena,
Alternate supplier to continue to provide progesterone:
Alere(ALR), one of the countries largest providers of 17P and related services, recently sent a letter to doctors informing them that the company will continue to offer the drug.
"Alere is committed to continue offering our current 17P Administration Service without interruption, which we pioneered in 2003 after the use of this compound was endorsed for specific patient indications by national medical societies such as the American College of Obstetricians and Gynecologists (ACOG)," the Alere letter to doctors states.