Female Viagra Marketing Set to Test Off-Label Sale Rules Post FDA Approval

On 18th August FDA finally approved Addyi (flibanserin) popularly known as the “Female Viagra”. Third time was the charm for the manufacturer, Sprout Pharma, who learnt from there previous two failures and gamed the Advisory Committee using aggressive campaign to claim that their product should be approved despite all the safety concerns and marginal effectiveness because there was no other treatment for loss of female libido. It doesn’t matter that the drug is not specific to loss of libido and that it’s mechanism of action is not known. FDA had a no win situation where it would have been criticized no matter if it decided to approve or not, and hence it took the safer route of approving the drug with severe limitations. The drug is approved with a black  box warning and a very aggressive REMS where both the physicians and pharmacists have to be certified before they can prescribe or dispense Addyi. These are expected to severely limit the market of this drug, but will it? The company has already announced that it will launch a very aggressive campaign to market Addyi hiring more than 150 sales personnel. The company principals are not new to pushing the envelope having already received a Warning Letter in the past for misleading marketing of another of their products. It is widely suspected that Addyi’s marketing will push similar boundaries of marketing a drug which otherwise will have limited market due to its marginal potential and major side effects. We have certainly not heard the last of Sprout Pharma. FDA better be keeping a close watch.