Reports to FDA drug ad watchdog triple

Reports of potentially misleading pharmaceutical pitches increased threefold from the previous year after the Food and Drug Administration launched its Bad Ad Program. The initiative encourages physicians and other health professionals to submit information on reputed untruthful advertising.

Before the launch of the program in May 2010, the FDA received an average of 104 annual reports regarding misleading promotions by drug companies. The number jumped to 328 the last 12 months, with 188 of those reports coming from physicians and other health professionals, according to a report the FDA released in June.

Less than half of health professionals' reports received further scrutiny -- "comprehensive review" -- from administrators within the agency's Division of Drug Marketing Advertising and Communications. Only 20% of reports from the public got comprehensive review. Many of the reports that did not get further review were referred to other FDA divisions because they involved products such as dietary supplements and medical devices that are outside the jurisdiction of the drug-marketing division.

Inappropriate promotions omit information about risks, overstate drugs' effectiveness, compare drugs in misleading ways or promote unapproved uses, the FDA said.

Many unfamiliar with program

Anyone reporting to the Bad Ad Program can do so without revealing their identity, but only 4% of reports were anonymous, the FDA's report said. The agency initially promoted the program by mailing letters to 33,000 physicians. The agency also has exhibited at a number of medical conferences, but plans to do more to get the word out.

"An external survey showed a 30% level of awareness among physicians," said Robert Dean, director of the Bad Ad Program. "The FDA will continue to exhibit at selected medical conferences throughout the year. We are also developing a continuing medical education course for health care providers. Additionally, we will actively be seeking opportunities to work with medical, nursing and pharmacy schools to help educate students about prescription drug promotion."

Among other events, the FDA will promote the Bad Ad Program at conferences hosted by the American Academy of Family Physicians, American Academy of Pediatrics and American College of Gastroenterology.

So far, the FDA has sent three warning letters and two notices of violation to companies for deceptive promotions as a result of reports from physicians and others. Misleading websites, mailers, YouTube videos and presentations by sales reps have received FDA sanction.

Physicians and other health professionals can report potential drug promotion violations by calling 877-793-3622 or sending an email to the FDA. More information about the program is available on the FDA website.