FDA's BAD AD Program
FDA Already Has the Power to Regulate Vaccine Advertising
As I wrote in my December 2, 2024 Short Stack:
“The FTC and the FDA share jurisdiction pursuant to a Memorandum of Understanding whereby the FDA has primary responsibility for claims that appear in labeling, including the package, product inserts, and other promotional materials available at point of sale. The FTC has primary responsibility for claims in all forms of advertising of foods, drugs (with the exception of prescription drugs) devices, and cosmetics.”
HHS already has the authority to bring enforcement actions.
“For prescription drugs and biologics [vaccines], section 502(n) of the FD&C Act requires advertisements to contain “* * * a true statement * * *” of certain information including “* * * information in brief summary relating to side effects, contraindications, and effectiveness * * *” as required by regulations issued by FDA.” Here
Prescription drug promotion must be truthful, balanced, and not misleading.
Founded in 2010, FDA has its own Bad Ad Program:
Oversight of Prescription Drug Promotion (OPDP) OPDP regulates prescription drug promotion made by or on behalf of the drug’s manufacturer, packer, or distributor, including:
TV and radio advertisements
Written or printed prescription drug promotional materials
Internet based promotion including social media
Speaker program presentations
Sales representative presentations
The following is a list of common issues to be aware of when you are exposed to prescription drug promotion. If you come across these promotional issues, please let us know by reporting them to the Bad Ad program.
Omitting or downplaying of risk
Overstating the drug’s benefits
Failing to present a “fair balance” of risk and benefit information
Omitting material facts about the drug
Making claims that are not appropriately supported
Misrepresenting data from studies
Misleading drug comparisons
Misbranding an investigational drug
“When you [assuming this means the public] come across an instance of potentially false or misleading drug promotion, you can help put a stop to it by reporting it.”
Email: BadAd@fda.gov
Call toll-free 855-RX-BADAD or 855-792-2323
Write:
Bad Ad Program
FDA/CDER/OPDP
5901-B Ammendale Rd
Beltsville, MD 20705-1266