Citing a limited ability to identify violative pharmaceutical advertising and promotional activities, the FDA has announced the launch of its “Bad Ad” Program. The Program encourages health care prescribers to directly report false and / or misleading drug advertising, marketing materials and promotional activities to the FDA – specifically activities that:
- omit or downplay the risks of a drug
- overstate the effectiveness of a drug
- promote off-label uses
- compare drugs in a misleading manner
In addition to asking doctors to whistle-blow on violations that occur during speaker programs, sales presentations, TV, radio & print advertisements, websites and print materials the FDA wants doctors to “monitor promotional activities that occur in private.”
FDA is particularly interested in what pharma reps say during sales calls, presentations, discussions at medical conferences, and in other face-to-face interactions.
Health care professionals who encounter suspect claims or activities are asked to notify the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC). As part of the program, the FDA will offer physicians training at medical conferences on how to identify misleading sales aides. In addition, the agency has simplified the reporting process which now includes a hotline and email address. Submissions may be anonymous.
DDMAC enforcement activity has risen dramatically over the past year, and the “Bad Ad” Program suggests that FDA hopes to take even more enforcement action in the future. The issue of concern here is whether by directly engaging the help of doctors as informal enforcement agents, the FDA is creating an “us against them” culture – where “us” is FDA and doctors, and “them” is the pharmaceutical industry.
While Word on Health is all for marketing compliance we wonder if doctors will answer the call. Do they have the time to be on the look-out for bad ads? Will they want to engage in time consuming activities for which there is no reimbursement? And do they want to be seen as the “enforcers?”
But assuming they will, SRxA can help guide you through the complex world of marketing compliance. We can help you deliver non-violative information to physicians. Contact us today for more information.