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Alliance Offers Comment on FDA Testosterone Prescription Labeling Communication

March 4, 2015   |   Alliance for Aging Research Team   |   FDA & Regulatory Policy, Men's Health
Alliance Offers Comment on FDA Testosterone Prescription Labeling Communication

We wanted to share our reaction to communication from the U.S. Food and Drug Administration regarding updates to the labeling of prescription testosterone products. Below are excerpts from the FDA’s comments:

“The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions…Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. Examples of these disorders include failure of the testicles to produce testosterone because of genetic problems, or damage from chemotherapy or infection. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.”

Our President & CEO Susan Peschin offered the following statement about the FDA’s comments:

“While we agree that the FDA got it right when they asked makers of testosterone products to include a label statement on safety and efficacy, the extra language they requested on defining hypogonadism is unintentionally ageist. The Alliance for Aging Research believes that the FDA should wait on the results of the required five-year study in the older adult population before mandating additional language. In this case, less really is more.”

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