The connection between the market and FDA

Dan Gorenstein Aug 18, 2015
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The connection between the market and FDA

Dan Gorenstein Aug 18, 2015
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The Food and Drug Administration is expected to rule Tuesday on what’s come to be called Viagra for women, a drug that purports to enhance a woman’s sexual desire.  

The FDA has twice previously rejected the application on grounds that it carries modest benefits and potentially significant side effects, like lowering blood pressure and fainting. Risk is heightened when using other medications including birth control. But an advisory committee has endorsed the pill, which, yes, is pink.

Groups including the National Organization for Women have thrown their weight behind a campaign called “Even the Score.” That effort has financial support from Sprout Pharmaceuticals, the company manufacturing the drug. Sprout recently flew a patient out to testify in front of the FDA.

Those moves have critics, including Dr. Adriane Fugh-Berman, a professor at Georgetown University.

“This may set a precedent of risky drugs being approved based on public relations campaigns rather than science,” she says.

The pharmaceutical industry certainly has used a patient’s story to make money before this. Emory University’s David Howard says what’s interesting is how important that story has become.

“There is a movement in medicine away from top-down paternalism,” he says. “There is a push to listen to the patient and let them dictate the terms on which a treatment is going to be judged.”

Whether the pill stimulates anyone’s libido, if this drug takes off, it could drive home the point there’s a market for woman who want to improve their sex lives; a market that’s largely been ignored.

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