The Food & Drug Administration is calling on physicians to increase their vigilance about misleading or biased messages from pharmaceutical company representatives, especially during private “detailing” visits, and to report questionable communications to a newly established hotline at: 877-793-3622.
The move, called the “Truthful Prescription Drug Advertising & Promotion Program,” aka, the “Bad Ad” program, is part of the FDA’s effort to get a better handle on communications between doctors and drug reps that go on behind closed doors, over dinner, and in other hard to track non-public venues. According to the Congressional Budget Office, drug companies spend upwards of $12 billion annually on private communications with physicians, three times the budget for direct to consumer ads.
FDA created a website for the project, http://www.fda.gov/badad that includes tips for spotting misleading drug messages. Among the tactics to watch out for are emphasizing efficacy but neglecting to mention risks of a particular drug, and suggesting unapproved or off-label uses.
The agency is also exhibiting at major medical conferences throughout the year, with a booth designed to teach physicians how to better detect biased or misleading messages.
Like many of FDA’s surveillance efforts, the reports from physicians in the field will be used to detect patterns of misleading communication. No one physician phone call will lead to a disciplinary action, but if FDA receives multiple calls about a particular product, drug rep, or drug company, officials will investigate more closely.
Drug company detailing programs have been the toughest nut for regulators to crack. The industry’s physician-focused and direct to consumer ads are overt, widely visible, and fairly easy to review. Detailing efforts are by their very nature, informal and largely out of sight. But they are a major component in drug promotion and need to be conducted ethically. Doctors can play a vital role in ensuring honesty, accuracy and completeness in detailing communications.
(Thanks to Lisa Richwine & Reuters News for their original report on this program.)
