Regulatory Focus™ > News Articles > FDA's 'Bad Ad' Program Marks Second Year of Operation

FDA's 'Bad Ad' Program Marks Second Year of Operation

Posted 19 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) Bad Ad Program, an effort to encourage physicians and other healthcare providers to report "suspected untruthful or misleading prescription drug promotion," is doing some advertising of its own.

In a "Year End Report" released this week, FDA's Office of Prescription Drug Promotion (OPDP) said it spent "significant time and resources" during the second year of the program's inception to increase the exposure of the Bad Ad program.

Those resources include advertisements in several major medical journals requesting that healthcare professionals "report advertising and promotion that you consider false or misleading." The advertisements are targeted at physicians, nurse practitioners and physician assistants.

Other public outreach efforts by the Bad Ad program involve web-based continuing education programs, the development of case studies that "will be made available as teaching tools" to healthcare professionals, staffed exhibits at major medical conferences, webinars and webcasts.

"Through these activities, OPDP believes that the Bad Ad program can bring about a culture of awareness among the nation's HCPs regarding misleading prescription drug promotion," the Office explained. "By raising awareness and reporting such activities to FDA, OPDP and the health care community can work together to protect the public from untruthful and misleading prescription drug promotion."

Enforcement Activities Lead to Results

In addition to education, the program also exercised its regulatory enforcement powers several times throughout 2011 and 2012, issuing a number of warning letters and untitled letters to both Pfizer and Merck for alleged infractions. One advertisement by Pfizer in particular received a "record" 33 complaints, prompting OPDP to send the company a warning letter seeking the removal of the television advertisement.

The Office said it plans to "continue to expand" its program in the coming year, with a particular focus on "creating a culture of awareness and knowledge of misleading prescription drug promotion and how to report suspected violations."

Read more:

Bad Ad Program: 2011-2012 Year End Report

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