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New FDA Oversight Threatens Testosterone Replacement New FDA Oversight Threatens Testosterone Replacement
The bill grants the FDA more oversight on small "compound pharmacies" that create specialized drugs for patients at the request of doctors. This is... New FDA Oversight Threatens Testosterone Replacement
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Testosterone replacement therapy has become one of the most effective means to combat aging and keep men in better health. However, a bill that is slated to go in front of the Senate as early as the end of this month has some dire implications for the popular treatment.

The bill, S.959, has already passed a vote in theĀ U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) and a vote on the Senate floor is expected any day now. The bill grants the FDA more oversight on small “compound pharmacies” that create specialized drugs for patients at the request of doctors. This is especially detrimental to the testosterone replacement industry because many patients that use Bioidentical Hormone Replacement Therapy (BHRT) get their drugs from compound pharmacies. The bill also gives the FDA authority to ban certain components of BHRT if the agency deems them to pose public health concerns.

While on the surface it would seem that the Senate and FDA’s actions are in response to the recent meningitis outbreak caused by contaminated steroid (non-anabolic) vials, a look at the history of the FDA’s war on BHRT tells a different story. In 2008, the FDA took action against the female hormone estriol, a component in a majority of compounded estrogen. The FDA’s action was the result of a request by a major drug company that produces synthetic hormones that compete with the safer, more natural bioidentical hormones used in BHRT. The language in S.959 allows for the FDA to shut down compound pharmacies that make BHRT drugs, while protecting the drugs made by large pharmaceutical companies. So safety doesn’t seem to be the motivation behind the bill as much as protecting the interests of large pharmaceutical companies who have the power to lobby the FDA and secure their dominance over this fast-growing medical industry.

Compounding pharmaceutical drugs is very important for some patients who are using hormone replacement. For example, the major drug companies’ testosterone replacement drugs may be ineffective at the doses available or the method of delivery may be ineffective. Oral pills sometimes don’t work for everyone to get to the proper level of testosterone that a doctor prescribes. If that is the case, a doctor can order a compound pharmacy to create a gel or cream to administer the proper dose. As these more effective means of delivering testosterone catch on, the major drug companies can’t compete because they are locked into the old ways of making only pills. This is the real threat that the FDA is fighting – not unsafe drugs, but ones that don’t profit their K Street lobbying friends.

And BHRT patients aren’t alone. It seems that Big Pharma wants to dominate the pet drug industry as well because the bill will also restrict vets from prescribing drugs made in compound pharmacies for cats, dogs, horses and other popular pets as well.

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