It turns out pharma's ad police aren't done doling out warnings in a year that's seen a historic few. The FDA's Office of Prescription Drug Promotion issued another warning last week, bringing its total for the year to three.
Amherst Pharmaceuticals and Magna Pharmaceuticals were on the receiving end of the OPDP's letter (PDF) for making "false or misleading" claims on a website and at a trade show about their Zolpimist insomnia treatment. The charge of wrongdoing included a reprimand for failing to submit the proper FDA labeling form as required before promoting the drug.
The letter charges that the drug webpage and the trade show exhibit panels did not communicate any risk information. On the misleading charge, the OPDP said claims of superior efficacy because of Zolpimist's formulation and oral mist delivery mode are not supported. "In fact, Zolpimist was approved as a 505(b)(2) application and, as correctly noted in the first claim on the webpage, demonstrated bioequivalence to Ambien, a zolpidem oral tablet, in healthy young volunteers," the letter reads. It also points out that the claim that Zolpimist “induces sleep” in 10 minutes is misleading because there are no data referenced—nor do any exist that the FDA is aware of—to support that.
Amherst bought Zolpimist, an oral spray approved for insomnia, in 2014 when NovaDel Pharma dissolved its business. Amherst has since partnered with Magna to market Zolpimist.
The OPDP letter asks that the two companies cease misbranding the drug and send a response and plan of action to the FDA by Nov. 29. The OPDP noted that it discovered the violations as part of its routine monitoring and surveillance program.
While this latest warning letter brings the total for 2017 to three reprimands, it remains an historic low year. The three for 2017 follow a general pattern of decline in the overall number of letters sent. In 2016, the OPDP sent 11 letters, up slightly from nine sent in 2015, 10 in 2014 and 24 in 2013.
The other two letters sent so far this year have been an untitled letter to Orexigen charging that its TV ad for weight-loss drug Contrave downplayed risks and a warning letter (PDF) to Cipher Pharmaceuticals over a professional detail aid for its opioid antagonist ConZip.