FDA has approved the so-called female Viagra drug, marking the first medication in the United States for the treatment of low libido in pre-menopausal women.
But the agency’s decision on Tuesday — which follows a well-orchestrated advocacy campaign financed by the drug’s maker, Sprout Pharmaceuticals — comes with a requirement that the company take steps to ensure that doctors prescribe flibanserin carefully and make women aware of its health risks.
The FDA is also mandating that the company conduct three post-marketing studies to better understand the serious risks that already are known from interactions between the drug and alcohol.
The outcome reverses two prior rejections when FDA concluded that the drug’s minimal benefits failed to outweigh the safety risks to the 1-in-10 U.S. women who the company estimates are affected by low sexual desire and may be treatment-eligible. Unlike Viagra, flibanserin must be taken daily; that has added to the concerns about its side effects.
The agency’s second disapproval in 2013 triggered the launch of the politically charged Even the Score campaign, which was run by a Washington-savvy public relations firm and backed by prominent groups like the National Organization for Women. Even the Score accused the FDA of sexism for turning down a sex-related drug for women while signing off on drugs for men with sexual dysfunction that also have serious side effects. […]
In clinical trials, women taking the drug had an average increase of 0.5 to one sexually satisfying event per month compared with those on a placebo.
The advocacy campaign’s apparent success — some former FDA staffers and other critics of the drug have credited it with influencing the FDA’s advisers who in June voted 18-6 for approval — is likely to raise new questions on how much political pressure, as opposed to scientific data, played into FDA’s ultimate decision.
The approval “send[s] a very clear message to companies whose products were previously rejected: Don’t worry about whether you can prove that your product is safe or effective, just keep applying, manipulate your data if necessary, and be sure to pay patients and advocacy groups to lobby Congress and insult the FDA,” said Diana Zuckerman, president of the National Center for Health Research. […]