Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
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.
To contact the reporter on this story: Bronwyn Mixter in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Brian Broderick at email@example.com
The warning letter is at http://src.bna.com/uuN.
Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)