For only the second time since the debut of its Bad Ad program nearly a year ago, FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) issued a warning letter prompted by a Bad Ad complaint.
In a March 21 letter, posted April 18, the agency said a “STATgram” for Infergen, a hepatitis C treatment by Kadmon’s Three Rivers Pharmaceuticals unit which carries a boxed warning, was false and misleading for all the usual reasons – risk information minimized or omitted, claims hyped and indication broadened. But it’s noteworthy for being only the second such letter to result from the Bad Ad program, which encourages healthcare professionals to report false and misleading ads for prescription pharmaceuticals. The rollout of the program was met with howls of derision from the pharmaceutical and advertising industries.
In a blog post last week, Peter Pitts, former FDA associate commissioner, called the program “compliance through secret combination” and “a bad idea for so many reasons – not the least of which is that it seeks to deputize people who don’t understand the law.”
A previous warning letter, prompted by a Bad Ad complaint, was issued in December to Hill Dermaceuticals for part of its website for Derma-Smoothe Body Oil, a dermatitis treatment. Hill Dermaceuticals president Jerry Roth told Advertising Age he believes the complaint came from a rival company.
By the end of January, the agency had received 239 complaints to the program, a little over half of which were from healthcare providers and 31% of which were from consumers (ostensibly, as detractors would point out, since complaints can be anonymous). Around 135 were deemed deserving of further investigation, Ad Age reported, though only half fell under DDMAC’s jurisdiction.
The agency, which will host a public Bad Ad webinar on Thursday, is rolling out Phase 2 of the program, which involves online CME and other awareness initiatives, with a Phase 3 to deploy next year.