FDA Issues Third Warning for Drug Advertising Violations


The FDA’s Office of Prescription Drug Promotion (OPDP) recently issued a warning letter to Amherst Pharmaceuticals and Magna Pharmaceuticals saying their promotional materials for the insomnia drug Zolpimist make false and misleading claims.

So far in 2017, the OPDP has issued only two warning letters and one untitled letter regarding drug advertisements. An untitled letter cites violations that don’t meet the threshold of regulatory significance for a warning letter. This contrasts with 2016, when the FDA issued 11 warning and untitled letters for drug advertising violations.

The other 2017 warning letter was to Cipher Pharmaceuticals Inc. for its promotions for the opioid ConZip; and the untitled letter was sent to Orexigen Therapeutics Inc. for advertisements for its weight loss drug Contrave.

“While this is only the third enforcement letter from OPDP this year, the letter is a wake-up call to sponsors and marketers who think that OPDP is not enforcing FDA policies,” John Kamp, executive director of the Coalition for Healthcare Communication, told me. The coalition promotes the free exchange of scientific and medical information and is composed of media, health-care, and other organizations.

Among other violations, the most recent warning letter said that Amherst’s webpage for Zolpimist and exhibit panels that Magna used at a conference didn’t include any risk information about Zolpimist and that gives a misleading impression about the drug’s safety.

Amherst no longer owns Zolpimist. Warren Lesser, president and chief executive officer of Magna, told me that Magna bought the drug from Amherst in May and he wasn’t aware that Amherst still had a website for the drug.

Lesser said Magna intends to fully comply and work with the FDA “by fixing the exhibit panels and making sure that everything we have out in the marketplace is totally accurate.”

Read my full article here.

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