FDA sends Sciecure Pharma rare, scathing letter over insomnia drug sales aid
- The FDA's Office of Prescription Drug Promotion (OPDP) sent a letter to Sciecure Pharma about a sales aid for its insomnia drug Doral (quazepam), citing lack of disclosure of risk, complete lack of fair balance, and claims of a favorable safety profile despite the drug's serious withdrawal side effects, RAPS reports.
- According to OPDP, asking readers to "see accompanying full prescribing information" does not comprise fair balance.
- The FDA pointed out that Sciecure's claims that Doral is safer and more effective than other drugs used to treat insomnia is false. The sales aid is being pulled immediately.
Anyone who has been involved in pharmaceutical marketing communications or advertising knows that receiving a letter from OPDP is a sobering event; however, this letter really got to the point, deconstructing the very poor approach to supporting claims of superiority based on a "unique mechanism of action."
In addition to being called out for not including risk information related to withdrawal, the integrity of Sciecure's referencing methodology was called into question, as the letter from OPDP noted that two of the four references were review articles that included pharmaockinetic information and information about quazepam's efficacy, but lacked information on controlled clinical trials. One reference was an algorithm that was not validated and the fourth was a study of the drug in nine healthy volunteers—the main problems being, they did not have insomnia, and the sample size was way too low.
Watch out: OPDP is looking. Fair balance has always mattered and always will.
- Regulatory Affairs Professional Society In Unusual Letter, FDA Dismantles Company's Drug Superiority Claims