Compounded medications.

Special interests in the pharmaceutical industry are trying to use the call for federal regulation of compounding pharmacies to outlaw compounded estriol and thyroid and replace them with standard drugs. Compounded, bioidentical estriol became popular in the first place because the standard drug used for the same purpose was proven to be dangerous, a risk for both heart disease and cancer. It would be understandable that the drug companies would want this huge market back. Here is how some of them have gone about it.

When the call for federal regulation of compounding arose, pharmaceutical companies formed the so-called Working Group on Pharmaceutical Safety to lobby for the bill. The group is led by Tommy Thompson, the former governor of Wisconsin and former Director of Health and Human Services under George W. Bush, and recently a failed Senate candidate, and Sarah Sellers, a former FDA official who worked on compounding pharmacy policy. The group represents some of the drug companies with vested interests in the compounding bill: the "participants" of the Working Group include TherapeuticsMD (a specialty pharmaceutical company), KV Pharmaceuticals, Auxilium Pharmaceuticals, and Mobius Therapeutics.

Not coincidentally, Thompson is chairman of TherapeuticsMD. And until recently, Sellers worked for Ther-RX, the marketing and distribution arm of KV Pharmaceuticals. You may recall our article on KV's fight against the compounded version of the successful progesterone-based drug 17P, which is used to prevent premature births; KV was displeased by the FDA's decision (due to grassroots pressure) to allow compounders to continue making the inexpensive 17P when KV wants to control the market with their high-priced version of the drug, Makena.

In other words, the Working Group on Pharmaceutical Safety and their clients have a direct financial interest in language that would allow the FDA to shut down vital compounded medications and thus a vested interest in passing S.959. Even more concerning is that TherapeuticsMD is in the process of developing a new form of the bioidentical hormones estradiol and progesterone; if these receive FDA approval and S.959 passes, it is very likely that these important hormones will no longer be available except in this new form-of unknown safety-and at what will almost certainly be outrageous prices.

Under S.959, all compounded versions of FDA-approved drugs will almost certainly be banned as "copies" of the approved drug, depending on how strictly that term is interpreted. We expect it to be defined broadly in order to ensure market exclusivity by eliminating competition from compounding pharmacies offering natural products. Because they are natural, these products cannot be patent-protected.


Action Alert! Sen. Lamar Alexander (R-TN) is calling for a vote on S.959 as quickly as possible. Even if you sent Congress your message on S.959 previously, please write them again.