Drug execs behind female sex pill have run afoul of FDA

WASHINGTON — A small drugmaker from North Carolina may succeed next week where many of the world’s largest pharmaceutical companies have failed: in winning approval for the first drug to boost women’s sexual desire.

The husband- andwife team that founded Sprout Pharmaceuticals is not new to the pharmaceutical business or even to marketing drugs to people frustrated with their sex lives. The couple’s previous company, Slate Pharmaceuticals, sold an implantable testosterone pellet to men with low levels of the hormone.

But Slate’s marketing push ran afoul of federal rules, making misleading, unsupported statements about the benefits of testosterone therapy while downplaying risks. In fact, when the Food and Drug Administration held a meeting examining the overprescribing of testosterone last year, it played Slate’s commercial as an example of inappropriate marketing.

That record worries Sprout’s critics, who see a troubling pattern in the aggressive tactics it has used to urge the FDA to approve the women’s desire drug, which was previously rejected twice because of lackluster effectiveness and side effects such as nausea, dizziness and fainting.

The search for a pill to increase women’s libido has been something of a holy grail for the pharmaceutical industry since the blockbuster success of Viagra for men in the late 1990s. Pfizer, Bayer and Procter & Gamble all studied — then abandoned — potential treatments for female sexual desire disorder.

“Th i s compa ny already has a history of unethical marketing,” said Dr. Adriane Fugh-Berman of Georgetown University. “If approved, I think this drug will be widely prescribed, and we would see an epidemic of adverse effects.”