FOR IMMEDIATE RELEASE
Drug Companies Attempt to Use Legislation
to Remove Compounded Medications from the Market
A controversial bill concerning compounded drugs is little more than a smokescreen for a power grab by the pharmaceutical industry
July 10, 2013 — The Alliance for Natural Health USA (ANH-USA) announced today that major pharmaceutical companies—under the guise of the Working Group on Pharmaceutical Safety—are pushing for the passage of S.959, the Senate compounding pharmacy bill, to weaken perceived competition by compounding pharmacies. The Working Group is composed of former FDA officials, powerful politicians-turned–industry advocates, and an influential lobbyist married to a key Senate staffer.
“The legislation is presented as a response to last year’s problems at the New England Compounding Center, where poor quality controls led to several batches of steroid injections becoming tainted with a fungus,” said Gretchen DuBeau, ANH-USA’s executive and legal director. “This was an outbreak that US Food and Drug Administration Commissioner Margaret Hamburg conceded last month was due to FDA inaction, despite the many complaints they had received about the facility. Unfortunately, this bill does little to actually increase the safety of compounded medicines or improve facility inspections, and rather makes it easier for FDA to ban many compounded drugs altogether.”
In particular, the bill allows the FDA to disallow entire categories of compounding drugs in so-called “complex dosage forms,” such as extended release products or transdermal patches. “Millions of women and men depend on compounded time-release thyroid medications in both the complete and active forms, neither of which is available in standard drug form,” DuBeau continued.
In addition, compounded estriol, which is biologically identical to the hormone produced by women’s bodies, is used by millions of women for hormone replacement therapy. “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,” DuBeau explained. “Now the pharmaceutical industry is trying to hijack this bill to outlaw compounded estriol and thyroid. Their goal is to replace these compounded medications with standard drugs and recapture their lost share of this massive market.”
In a remarkably candid interview with Bloomberg, the CEO of TherapeuticsMD, a key player in the Working Group on Pharmaceutical Safety, recognized the superior safety of bioidentical hormones. DuBeau stated, “This is important because FDA’s main argument against estriol has been that it is by definition unsafe because it has not won FDA approval. This CEO openly admits that his company sees these hormones as a $10 to $12 billion market that they want to control by offering them as FDA-approved drugs.”
Even more telling, ANH-USA has obtained a document in which TherapeuticsMD, pitching itself to potential investors, describes the safety and efficacy of bioidentical hormones. They also give their investors statistics on the bioidentical HRT market, reveal that well over three-quarters of the market is currently held by compounding pharmacies, and state that this is the market they are pursuing.
“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. Certain drug companies want to take advantage of what is supposed to be regulation of the compounding industry by replacing compounded products with their own,” DuBeau concluded. “Will Congress please take note and amend this legislation before it is too late?”
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About the Alliance for Natural Health USA (ANH-USA)
The Alliance for Natural Health USA is part of an international organization dedicated to promoting natural, sustainable healthcare through good science and good law. We protect the right of natural health practitioners to practice and the right of consumers to choose the healthcare options and treatment modalities they prefer, including complementary and alternative medicine. As a membership-based organization, we unite consumers, practitioners, and industry to speak with a common voice and have worked since 1992 to shift the medical paradigm from an exclusive focus on surgery, drugs, and other conventional techniques to an “integrative” approach incorporating food, dietary supplements, and lifestyle changes.