FDA’s Bad Ad Program

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The Food and Drug Administration (FDA) has launched a “Bad Ad Program,” an outreach effort aimed at educating healthcare providers and urging them to report misleading drug advertisements. The Division of Drug Marketing, Advertising, and Communications (DDMAC), in the FDA’s Center for Drug Evaluation and Research, administers the program.

The program will help healthcare providers recognize misleading drug promotion and provide them with a simple way to report back to the agency. 

About $4 billion out of a $20 billion advertising budget goes toward patient-targeted advertisements. Some drug industry critics feel that TV drug ads emphasize the benefits of the medication and minimize the risks.

According to FDA regulations:

Prescription drug advertising must:

  • Be accurate
  • Balance the risk and benefit information
  • Be consistent with the prescribing information approved by FDA
  • Only include information that is supported by strong evidence from clinical studies

What types of promotion does DDMAC regulate?

  • Sales representative presentations
  • Speaker program presentations
  • TV and radio advertisements
  • All written or printed prescription drug promotional materials

DDMAC does not regulate promotion of:

  • Over-the-Counter Drugs
  • Dietary Supplements
  • Medical Devices

Common Violations:

  • Omitting or downplaying of risk
  • Overstating the effectiveness
  • Promoting off-label, or unapproved, uses
  • Misleading drug comparisons

As part of its new program, FDA will offer doctors training at medical conferences to help spot misleading ads. They can report advertising violations anonymously by e-mailing badad@fda.gov or calling 877-RX-DDMAC.

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Sources:

The FDA’s Bad Ad Program: http://www.fda.gov/badad  

SF Gate

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