Monday, June 8, 2015

FDA panel recommends approval of controversial drug FDA has rejected twice already

Almost exactly five years ago I reported on a German pharmaceutical company's attempt to market a drug claiming it helps treat a disorder related to female sexual desire while others argued that the pharmaceutical company were trying to take advantage of women to sell them something they did not need (and potentially endanger their health) in pursuit of billion dollar profits.  The FDA eventually rejected the proposal after a study showed the drug failed to meet agreed-upon criteria to establish its effectiveness.  Go here for my report, which includes the trailers of a documentary on the controversial drug.

After the failed attempt to introduce the drug in the American market, the German pharmaceutical company dropped the drug. However, Sprout Pharmaceuticals picked it up and again submitted it for approval in 2013. The FDA nixed it, again.

Yet, just a few days ago, an FDA advisory panel voted to recommend approval of the drug.  The FDA does not have to follow the advise of the panel but it usually does.

It will be interesting to see if the FDA does approve the drug this time around, since none of the reports I have seen mentions that there are different studies supporting a different conclusion than the ones available when the drug was rejected in the past.  If approved, I am sure the controversy discussed in the documentary mentioned in my earlier comment will be revived.  And when the drug is shown to cause injuries, it will inevitably result in litigation.  (Yes, I said "when" rather than "if" on purpose.  As has been discussed elsewhere, and reprinted in Smithsonian magazine "the drug also comes with side effects like sudden drops in blood pressure, sleepiness and fainting spells, it's unclear whether the benefits outweigh risks.")

For more information on the controversy, go here.  For more on the approval process, NPR has a story here.  For more on the drug itself, Smithsonian has a story here.

UPDATE 6/13/15:  The New York Times has published a short editorial on this subject here.  Among other things it concludes that "the panel’s recommendation was laced with so many caveats that it seems clear that this particular drug — flibanserin — is only marginally effective and carries some risk of serious adverse effects."

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