FDA: Bad Ad program tripled reports
Reports of allegedly misleading or untruthful promotion have more than tripled under the FDA's Bad Ad program, the agency said in a review of the program's first full year.
The agency received 328 reports over the year since the program's inception, in May 2010. Historically, reports averaged around 104 a year before Bad Ad was unveiled, with great fanfare and much coverage. Of the 328 reports since the program began with a letter to more than 33,000 physicians, 188 were submitted by healthcare professionals, while 116 came from consumers and 24 from regulated industry. Of the 188 from healthcare professionals, 87 were cleared for “comprehensive review, demonstrating a relatively strong level of knowledge in the medical community about what constitutes misleading promotion.” Twenty-four of the reports from consumers cleared that bar and 14 of those from industry. Those leads led to three warning letters and two untitled letters.
Just 4% of reports were submitted anonymously, the agency said, taking aim at industry critics who saw shades of a regulatory secret police in the program's use of anonymous reporting.
Going forward, the agency said “based on overwhelmingly positive feedback” it will expand the program through development of a web-based continuing education program, collaboration with medical schools and continued canvassing of trade shows such as those of the American Academy of Physician Assistants, the American Academy of Nurse Practitioners and the American Academy of Family Physicians.
Warning letters were issued to: Hill Dermaceuticals, for a “particularly egregious website” promoting Derma-Smoothe Body Oil; Three Rivers Pharmaceuticals for an Infergen direct mail piece that a clinical pharmacist reported; and Shire, for a Vyvanse magnet that “an astute nurse” flagged and which the agency found “was designed to hide the important risk information from plain view.” Untitled letters went to Forest Laboratories for statements made by a sales rep regarding fibromyalgia drug Savella, which the agency characterized as “representative of the types of promotion we hope to curtail in field-based settings,” and Warner Chilcott for a YouTube video depicting a violative detail of Atelvia.