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The FDA warned Amherst Pharmaceuticals and Magna Pharmaceuticals that their promotional materials for the insomnia drug Zolpimist make false and misleading claims.
Amherst’s webpage for Zolpimist and exhibit panels that Magna used at a conference weren’t submitted to the FDA at the time of initial use as required, the Food and Drug Administration said in a recent warning letter.
So far in 2017, the FDA’s Office of Prescription Drug Promotion (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. 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. This contrasts with 2016, when the FDA issued 11 warning and untitled letters for drug advertising violations.
“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 Bloomberg Law in a Nov. 28 email. The coalition promotes the free exchange of scientific and medical information and is composed of media, health-care, and other organizations.
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,” Warren Lesser, president and chief executive officer of Magna, told Bloomberg Law Nov. 28.
Lesser said Magna bought Zolpimist from Amherst in May and he wasn’t aware that Amherst still had a website for the drug.
Amherst couldn’t be reached for comment.
Magna is based in Louisville, Ky., and Amherst is based in Basking Ridge, N.J.
Zolpimist (zolpidem tartrate oral spray) is indicated for the short-term treatment of insomnia. The prescribing information contains warnings and precautions regarding central nervous system depressant effects and next-day impairment, among others.
While the webpage and the exhibit panels include information about the efficacy of Zolpimist, they don’t include any information about the drug’s risks, the FDA said. The agency said this creates a misleading impression about the drug’s safety.
The webpage and the exhibit panels also misleadingly suggest that Zolpimist is clinically superior in efficacy to other oral zolpidem products because of its formulation and delivery mode, the FDA said. No evidence is cited to support these claims.
Also, the webpage says Zolpimist induces sleep in 10 minutes, and the FDA isn’t aware of any data to support this claim, the warning letter said.
The FDA asked the companies to stop using the webpage and exhibit panels and submit a response to the letter.
The warning letter was signed by Andrew S.T. Haffer, division director of advertising and promotion review 1 in the FDA’s Office of Prescription Drug Promotion.
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