FDA'S ABRAMS: INADEQUATE RISK INFORMATION MAIN CAUSE OF DDMAC WARNINGS
Pharmaceutical firms should design drug promotions in a way that gives equal weight to a product's risks and claims, suggests the head of the FDA's advertising oversight division, which has ratcheted up its scrutiny of drug promotions in recent months.
Over the past 12 months, the FDA has issued 17 warning letters for misleading prescription drug promotions, a 375 percent increase over the average in previous years, Thomas Abrams, director of the agency's Division of Drug Marketing, Advertising, and Communications (DDMAC), said during a recent Food and Drug Law Institute conference on advertising and promotion.
"The positive aspect of [the increased enforcement] is that it has been effective in stopping misleading promotions, and also resulted in the dissemination of corrective messages," he said. "The bad side is that these letters were necessary to ensure compliance in this area. I would prefer to look at all promotions in the marketplace and say, 'We have nothing to act on.'"
Misleading promotions were also found in a wide array of promotional vehicles, including print and broadcast DTC ads, journal ads, patient testimonial videos, websites and exhibit booth panels. It is no coincidence that the violations spanned many types of promotions, Abrams said.
Despite the large number of warning letters, there are some indications that the FDA's past guidances on the topic are starting to produce better compliance, Abrams said. The agency hopes soon to issue a draft guidance on risk information, he said, adding "the FDA has put a very high priority on this guidance." The agency also is preparing final guidances that provide recommendations to industry on developing help-seeking ads and brief summaries, Abrams noted.