FDA Approval of the “Pink Pill” a Probable Outcome?

Is the FDA Approval of the “Pink Pill” a Probable Outcome?

18jdwo1qlvkujjpgA failure to approve flibanserin would set a dangerous precedent. Why? Because the pharmaceutical company did everything the FDA asked it to do, and the results came out statistically significantly better than placebo—which was the desired endpoint. If the FDA were to deny approval of the drug, it would be saying, in effect, that it can change its mind in the middle of the argument.

In reality, the FDA is likely to say yes to approval, but with restrictions, as that is what its advisory committee recommended. What those restrictions will be remains to be determined, but they are likely to resemble those of other drugs in the class, such as selective serotonin reuptake inhibitors (SSRIs), including a warning to be careful using flibanserin with alcohol until the drug’s effects are clear.

 

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Contributed by

James A. Simon

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