Although the agency calls the program "Bad Ad," its interest goes beyond broadcast and print advertisements to include misleading in-person presentations.
Housed within the Division of Drug Marketing, Advertising, and Communication (DDMAC), the program is intended to increase the number of eyes and ears available to monitor pharmaceutical companies' promotional activities -- especially speaker presentations and in-person "detailing" that DDMAC enforcement personnel seldom have a chance to see for themselves.
According to a "Dear Colleague" letter from FDA Commissioner Dr. Margaret Hamburg, direct-to-consumer advertising accounts for only a small portion of drug companies' total promotional effort. She cites Congressional Budget Office estimates that the pharmaceutical industry spends three times as much on detailing and other advertising targeted to healthcare professionals.
"I am asking you to help FDA in our efforts to stop misleading prescription drug promotion," Hamburg wrote.
On a new FDA Web page for the program, the DDMAC lists examples of over-the-top tactics that it hopes physicians will report.
These include omissions of risk information, promotion of off-label uses, and exaggerating a drug's effectiveness.
"You attend a speaker program which features a slide show that presents efficacy information about Drug X, but no risk information. This presentation would be misleading because it fails to include a fair balance of benefit and risk information for Drug X," according to the Bad Ad Web page.
Another example focuses on an in-person sales pitch in which a drug is touted as providing results "in as little as three days." If the drug's label indicates that most patients showed benefits after 12 weeks, the statement would be misleading, the agency wrote.
The FDA has set up a special e-mail address to receive tips on potentially illegal promotions, BadAd@fda.gov.
The agency will accept anonymous reports, but it would prefer that tipsters provide names and contact information so that enforcement staff can request additional information if necessary.
It's even more helpful if tipsters can provide documentary evidence of the violation, such as actual promotional materials. Even written notes of oral presentations can be useful, the FDA suggested.
Beginning this month, Hamburg's letter noted, the DDMAC will be renting booth space at major medical meetings to publicize the effort to the healthcare community.
The FDA noted that the DDMAC's legal authority, and hence the Bad Ad program, extends only to prescription drugs. Medical devices, over-the-counter drugs, and nutritional supplements are outside its jurisdiction.