Testosterone and the FDA

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The Federal Drug Administration regulates testosterone as a treatment for symptoms of menopause.

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Episode 51 of the BioBalance Healthcast begins a discussion of how the Federal Drug Administration—or FDA—regulates drugs, and in particular, testosterone for women.

Testosterone is a Legal Drug

Testosterone has been in medical use since the early 1930s, and has never been illegal. It is not only legal when administered in synthetic and bioidentical forms by a licensed physician for certain approved conditions, it is an essential hormone that should be replaced in both women and men who suffer from hormone deficiency.

In addition to be being legal under appropriate medical conditions, testosterone is regulated, in every form in the United States by the FDA, the Food and Drug Administration. Canada has a similar agency that regulates all drugs.

This FDA regulation of synthetic testosterone production by drug companies and pharmacies ensures that:

  • the product is pure
  • the dose on the label is consistent with the drug
  • it is dispensed in a way that leaves a paper trail
  • there are lot numbers and expiration dates on the drug in case there is a recall.

Approved? Regulated?

The term “approved by the FDA” is different than “regulated by the FDA”. Approval represents yet another level of restriction beyond regulation. When the FDA approves, or “sanctions” drugs, it approves them for a particular purpose or set of purposes, and only that specific purpose or set of purposes. This, however, does not restrict usage beyond those approved parameters.

Off Label Use?

Although bioidentical hormones such as testosterone are not approved for women in pellet form as they are for men, this highly safe and effective treatment is legally, openly, safely and economically available for “off-label use” for women for the treatment of hormone deficiency, just not as widely as it would be were it FDA approved for this purpose.

Sometimes Dr.’s Don’t realize it is Off Label

Many physicians, including these conservative ones, often don’t even recognize that some of the medications they routinely prescribe are in fact not approved by the FDA for the disease for which they are using it. The reason is that the use of that drug for that particular purpose, though not approved, is so common that they may even have been trained in medical school to use it for that purpose. It may never come up that the FDA has never approved it.

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