FDA issues all-time low number of violation letters for drug promotions

Even as the pharmaceutical industry continually advertises its medicines, the Food and Drug Administration office that monitors promotions has been issuing fewer and fewer infraction letters to drug makers. And last year amounted to a new all-time low — only nine letters were issued.

Moreover, a trend may be shaping up. The combined number of letters issued over the past two years amounted to just 20, which was well below the number of letters sent each year between 2009 and 2013, according to the Eye on FDA blog, which tracks agency oversight of pharmaceutical marketing.

Over the past decade, the FDA Office of Prescription Drug Promotion generally sent recalcitrant drug makers between 20 and 30 letters each year, although it reached a high of 52 in 2010. But the agency issued more than 100 letters each year between 1997 and 1999. In 1998, 156 were issued, which was right after the FDA expanded the scope of direct-to-consumer advertising. 

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The decline may reflect the FDA’s “unfinished work” in formulating guidelines for digital media, according to Mark Senak of the public relations firm Fleishman-Hillard, who writes Eye on FDA. This is an ongoing issue that has flummoxed drug makers, who are grappling with ways to harness social media to reach consumers while trying to avoid regulatory infractions.

Indeed, although drug makers have embraced the Internet — at least, in varying degrees — the FDA has been slow to issue guidelines that might prompt the agency to uncover violations that warrant letters. The agency did issue guidelines in June 2014, but these mostly provided a framework for correcting misinformation on websites run by others, while another discussed how Twitter should be used.

“Not only are there many gaps, but the [FDA] guidance documents that have been issued raise almost as many questions as they answered,” writes Senak. “Meanwhile, digital media continues to rapidly evolve, bringing new questions into the marketplace.”

Most of the violations cited in the letters, by the way, were issued because a promotion lacked or minimized risk information, followed by companies that made unsubstantiated claims.

So what does FDA say?

An agency spokeswoman writes us that the OPDP “uses a risk-based approach to carefully allocate its resources … to have the greatest beneficial public health impact.” Those resources, she explains, are directed toward policy and guidance development; reviewing product labels and launches, including TV ads; enforcement; and training and communications.

“It is apparent that that one cannot get a complete picture of OPDP’s program area by looking at a snapshot of time for enforcement letters.  Reviewing the number of compliance actions that OPDP takes within a year time frame does not take into account the work that OPDP does on the other priorities to assist companies with compliance.”

One other point worth noting — Eye on FDA writes that, for the past few years, most of the OPDP violation letters “largely involved” drug makers that are “lesser known” and typically have fewer products on the market. Are smaller drug makers bigger risk takers when it comes to promotions? Have the biggest drug makers figured out how to avoid infractions, or are they simply shying away from some efforts?

We asked the FDA for insight and will update you accordingly.

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