FDA oversight limited on off-label promotion

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A new report from the Government Accountability Office (GAO) casts doubt on the FDA's ability to monitor off-label drug promotions. It is illegal for manufacturers to advertise or promote a drug “off-label,” or for use in any way beyond what the FDA has approved.

Officials at the Division of Drug Marketing, Advertising, and Communications (DDMAC) – the advertising regulatory arm of the FDA – said they receive “substantially more materials than the agency can review,” according to report.

From 2003 to 2007, the FDA took seven months on average to send regulatory letters to companies promoting drugs for off-label uses, once they'd been identified. Companies then took an average of four months to fully comply with the letters, according to the report. In the case of Reliant Pharmaceuticals, for example, the FDA issued a warning letter on September 14, 2006, regarding off-label promotion of its drug Rythmol SR. The FDA and Reliant then exchanged letters and participated in teleconferences for more than seven months before the first set of corrective promotional materials appeared on April 17, 2008, according to the report.

The extent and variety of promotional materials makes it difficult for the FDA to provide comprehensive oversight, the report contends. In 2007, the FDA received 68,000 final drafts of promotional materials, up from 40,000 in 2003. Since DDMAC is unable to review all submissions, staff members “rely on a process to prioritize their review of submissions that is intended to address those submissions that have the greatest potential to impact public health. However, because DDMAC staff are not able to examine all submissions to the agency, this process is not systematically applied to all submissions,” noted the report. “As of March 2008, DDMAC had the equivalent of 44 full-time staff devoted to overseeing prescription drug promotions. This oversight involves reviews of submitted materials and monitoring and surveillance efforts.”

The FDA sent 42 off-label-related regulatory letters between 2003 and 2007, none of which necessitated referral to the Department of Justice for enforcement action. The GAO report addresses concerns expressed by Sen. Charles Grassley (R-IA), and can be found here (pdf).

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