The FDA blundered badly on the Addyi approval

This morning, millions of women will wake up to hear about the new "female Viagra" pill Addyi. It will be on television, in your newspaper, on the radio and all over the Internet.

With a vengeance.

So without ever having to write a line of advertising copy, little Sprout Pharmaceuticals is being handed the world's biggest misleading advertising campaign for a new drug. It won't cost them a dime and the intense onslaught of shallow mainstream media attention can't be controlled by the FDA.

Calling Addyi (flibanserin) a "female" or "pink" Viagra would be exactly the kind of marketing abuse that would land the founders of Sprout right back into the same trouble they experienced when they hyped a testosterone therapy for men as a tonic for HIV. The readily available Viagra, though, deals with the hydraulics of erectile dysfunction, while Addyi is targeted at the pleasure centers of the mind--boosting levels of dopamine and norepinephrine in the brain's reward pathways--using a mechanism that the agency freely admits it doesn't know.

Just a glance at the FDA's statement on the approval showed that the agency was treating this one differently. A senior FDA administrator, Janet Woodcock, got to do the honors on the announcement, providing an opening for the agency to reassure the public of their support for women's health. Then there was a lengthy explanation of all the measures being put into place to make sure that patients wouldn't be exposed to considerable risks associated with drinking and Addyi. (Sprout, meanwhile, won't advertise the drug for 18 months.)

This is a bit of false and misleading advertising on the FDA's part.

Aside from the comical notion that a vigilant FDA and a host of dedicated and certified practitioners can separate sex and alcohol, Sprout is getting a monster promotional blitz for a drug that is typically only marginally effective in promoting sexual satisfaction among a group of women who meet the profile for sexual dysfunction. The biotech got to this point, at least in part, because it helped drive a public campaign for adoption, orchestrated by a group called Even the Score, which leveraged the viral nature of the product and the health problem to mount a very effective PR push for an approval.

Company advertisements are the least of the FDA's problems.

Over the last few years the FDA has prided itself on accelerating the approval process for drugs, providing faster reviews and offering a number of expert panels that lean heavily on the side of an approval. Any marginal cancer drug with a clearly defined risk profile, even if it's a bad one, can get approved for late-stage, dying patients. Drug approvals on an annual basis have surged.

And there's a perfectly legitimate argument to back that up.

But in approving Addyi, the FDA has gone overboard, exchanging greater efficiency in favor of purposeful permissiveness. And it's lowering its standards on the risk/benefit equation by ignoring the realities of the Internet.

The agency can't control the viral campaign that's already well under way. It can't control prescribing habits or, more importantly, the demand for this drug. It can't prevent the side effects that we will now be seeing as the drug starts to become available to a much wider population than it's intended for. And it's the kind of blunder that could well cost the entire industry if the inevitable backlash causes the FDA to grow overzealous about safety issues.

This is a regulatory failure of the worst kind.

-- John Carroll (email | Twitter)

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