How Can An Ad Be A "Bad Ad"?

If your company manufactures, sells and/or distributes prescription pharmaceuticals, you need to be aware that the FDA has just launched a promotional campaign to solicit volunteered information from medical professionals concerning "bad ads". What is a "Bad Ad"? A "bad ad" is one in which:

  • advantages of a drug are being promoted with no mention of risks to a patient;
  • the effectiveness of a drug is being overstated:
  • the use of drugs is being promoted off-label, or for unapproved uses, beyond the use or uses for which the drug was submitted to the Food and Drug Administration; and/or
  • drug comparisons are being made that are misleading.

Your company should be aware of this program. When a "bad ad" is promoted, the FDA's Division of Drug Marketing, Advertising and Communications, or DDMAC. will be investigated by DDMAC by being evaluated to determine if regulatory action need be taken, such as, in order of increasing severity:

  • Untitled Letter;
  • Warning Letter;
  • Notice of Violation Letter; or
  • Referral for criminal investigation.

The FDA will begin Phase 1 of the "Bad Ad Program" campaign in May, 2010, by initially exhibiting at booths at major medical conferences where reviewers will be speaking with prescribers regarding how to recognize misleading prescription drug promotion and how to report any potential violations to the FDA.

You can be proactive to protect your company, by assuring: that all promotional ads are accurate, that they balance the risk and benefit information, that they are consistent with the prescribing information approved by the FDA, and that they only include information that is supported by strong evidence from clinical studies.

For more information, see: http://health.law360.com or http://www.fda.gov.

Tags: