Synthetic versions of the quintessential male hormone are prescribed to thousands of patients in the U.S. to treat fatigue, sagging libido and other signs of testosterone deficiency.
But when they're applied as topical gels, they have an unpleasant propensity to rub off on other people. In addition, the FDA is concerned about the growing use of testosterone by anti-aging clinics seeking to restore youthfulness to Baby Boomers and by the abuse of such drugs in sports.
It's no surprise the FDA is being so vigilant. Sales of testosterone products already on the market have rocketed 25% in the 12 months ending in June, to just under $1 billion. Boomer lust for the hormone is now spurring a land grab by companies that make it. On September 28, 2009, drug giant Abbott Laboratories paid $6.6 billion to acquire Solvay Pharmaceuticals, which makes the leading testosterone product, AndroGel.
"The driving element is demographics," David P. Holveck, CEO of Endo Pharmaceuticals, says. Analyst Annabel Samimy, who covers Endo and Auxilium for Thomas Weisel Partners, expects continued double-digit growth for such products, figuring that only 10% of patients who have low testosterone are currently treated.
Testosterone is one of the fastest-growing therapies prescribed by the $80 billion-a-year anti-aging industry, which has embraced it as the cure du jour for andropause, more commonly known as male menopause. Conservative doctors question the existence of such a malady, whereas I thought a red Porsche 911 would help me through male menopause and testosterone makers shy from discussing it because they're not allowed to promote the drug "off-label"--for users not endorsed by the FDA. Still, off-label prescriptions are likely to account for much of the market's rapid growth.
The fact isn't lost on the FDA: During a press conference to announce the black boxes, an agency spokeswoman said she was alarmed that 25,000 testosterone prescriptions per year are written off-label for women, who use it to boost their libidos.