April 29, 2011 – In a Webinar yesterday, the U.S. Food and Drug Administration’s (FDA’s) Division of Drug Marketing, Advertising, and Communications (DDMAC) reminded medical marketers of its continued actions to enhance surveillance and monitoring of industry marketing by urging physicians and other healthcare professionals to report any potentially misleading marketing activities to DDMAC.
Although the year-old program has resulted in only two Warning Letters to date, the DDMAC clearly wants the industry, doctors and the public to know it intends to aggressively enforce its rules. “I have my doubts about the value of this program,” said John Kamp, executive director of the Coalition for Healthcare Communication, “but FDA is sending a clear signal. We must pay attention.”
Catherine Gray, DDMAC management advisor, explained in the FDA-sponsored Webinar that although DDMAC is charged with regulating print, broadcast and oral communications made by or on behalf of prescription drug companies, it cannot “possibly be in every discussion with every sales rep,” so it is asking healthcare providers to use the agency’s “Bad Ad” initiative to report any marketing activities that could potentially be in violation of FDA marketing rules.
During the Webinar, Gray explained that the Bad Ad outreach program is designed to educate healthcare providers about the role they can play in helping the FDA enforce rules requiring prescription drug advertising and promotion to be truthful and not misleading.
The program “fills gaps” between what DDMAC finds during its normal surveillance activities and allows the agency to gain important intelligence regarding company-driven interaction with healthcare professionals, “including oral statements made in physician offices or at industry-sponsored lunches or dinners,” she said. “The program was created by two former drug reps who are very familiar with what goes on behind closed doors.”
Gray outlined the most common types of drug promotion activities that could be considered misleading:
- Omitting or downplaying the product’s risk factors;
- Overstating effectiveness of the product;
- Making misleading drug comparisons without substantial evidence; and
- Promoting unapproved use(s) of a drug.
She noted that this last violation type represents an area “where individuals can be very helpful” because physicians may be more likely to be apprised of unapproved uses in private settings. She indicated that healthcare professionals who become aware of any of these potential violations should submit – through the Bad Ad program e-mail address (BadAd@fda.gov) – their name (or the complaint can be anonymous), the name of the drug in question, when the activity occurred and what it was, “as well as the drug rep’s name” if one was involved. Gray remarked that competitors also may use this forum to file complaints.
Then, DDMAC will evaluate the allegation and determine whether action – such as an Untitled Letter or a Warning Letter, a criminal investigation, seizure, injunction or consent decree – is warranted. “Even if the agency does not take action after you submit a complaint, the data collected through the program is valuable information for ongoing DDMAC surveillance,” Gray told Webinar attendees. Further, she described several DDMAC enforcement actions that were a direct result of complaints received through the Bad Ad program.
Gray concluded by telling attendees that when physicians tell DDMAC about specific incidents, “we can take steps to stop it.” Healthcare professionals can have a big impact … in stopping misleading promotion,” she said.