The Addyi Report Card: Crooked Valeant Fools FDA Again | Pharma Industry Regulation | Scoop.it

"Fool me once, shame on you; fool me twice, shame on me," should be FDA's response to a report card released by the National Women’s Health Network advocacy group and shown here.

FDA was first "fooled" into approving Addyi based on a dicey self-assessment questionnaire, which formed the basis for the drug's efficacy in clinical trials (read "The #Pharma-Developed Self-Assessment Questionnaire that Got Addyi Approved") and by "patient advocate" testimony (read "The Power of Patient Input: How FDA Learned to Love & Approve Addyi") sponsored by Sprout, the company that brought Addyi before the FDA and which was bought by Valeant after the drug was approved.

Finally, Sprout's “Even the Score” campaign claimed that there was sexism inherent in the number of FDA-approved treatments for sexual disorders (read "Flibanserin (Addyi): The Title IX of Drugs or the Pill for No ill?").

Will the FDA be fooled again by "crooked" Valeant, whose business and accounting practices are under criminal investigation by U.S. prosecutors (see here)? Evidence from the Report Card says "Yes!"

 

More here.