Uploaded by LawsuitGuru on Aug 24, 2010
FDA monitors the way drug companies advertise and promote prescription drugs to help assure that the information is accurate and balanced. But it is difficult for the agency to check on these activities when they take place in doctors' offices, or in industry-sponsored meetings and training sessions. That is where the new "Bad Ad" program comes in. By taking part in this FDA program, healthcare professionals can help ensure that prescription drug advertising is truthful, and that it's not misleading. The "Bad Ad" program asks healthcare professionals to recognize misleading or inaccurate promotion by drug companies, and then report it to the FDA. That way, FDA can take steps to address possible violations.
Here are some examples of situations to look for:
• A speaker's slides describe a drug's efficacy, but there is no risk information. That is considered misleading because the presentation doesn't provide a fair balance of benefit and risk information.
• A company representative in a commercial exhibit hall says that a drug is effective for a use that has not been approved by FDA. This is promoting an "off-label" use, and it is illegal.
• Overstating the effectiveness of a drug --- for example, saying a drug works in as little as three days, when most of the patients in the drug's clinical trials did not show results for three months.
FDA is kicking off the Bad Ad program at major medical conferences this summer, so stop by an FDA booth to learn more about recognizing and reporting misleading drug promotions. In any case, the most important thing is to report these to the FDA. Just send an email to badad@fda.gov or call (877) RX- DDMAC.
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