FDA Policy/General

Flat Ad Enforcement in 2016

CDER’s Office of Prescription Drug Promotion (OPDP) issued 11 letters to companies in 2016, slightly more than in 2014 and 2015. An online survey by Eye on FDA finds that there were three Warning Letters and eight Notices of Violation last year. All 11 involved only a single communications vehicle such as a brochure or a Web site.

All but three of the letters went to drug companies that are outside of the top 50 based on sales volume. The survey says that the communication vehicles involved were primarily digital, rather than print, with video being predominant. There were letters about three YouTube videos, two DTC ads, and one video. Letters not involving videos addressed an e-mail, an exhibit panel, a coupon, and two Web pages.

There were 20 violations cited in the letters for 2016 and they covered drugs in multiple therapeutic categories.

“In virtually every examination of the violations cited in letters, the number one violation is always the minimization or omission of risk information,” the report says. “This year was no exception, with seven of the 20 violations being in that category. The real point of interest this year, however, was in the number of letters issued for the promotion of an unapproved drug. There were three such letters, which does not sound like a large number in and of itself.” The blog points out that in its database on Warning Letters and Notices of Violation through 2004 with over 300 letters covering over 1,000 violations, only 13 involved promotion of an unapproved compound, all involving very small companies.

“That means that nearly one-fourth of all the letters issued for unapproved drug promotion in the last 12 years were issued in 2016, perhaps a signal that this has been a watch area for OPDP or that the agency has intended to make a point about it,” the report says. “The issues that FDA cited in the letters had to do with a combination of factors including use of a trade name, referring to an indication, and use of conclusory language or tone with respect to the establishment of safety and efficacy.”

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