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FDA issues final guidance for direct-to-consumer ads
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WASHINGTON — The Food and Drug Administration (FDA) issued final guidance concerning consumer-directed broadcast advertisements for prescription drugs.
The final guidance described an approach that fulfills the requirements for prescription drug advertisements broadcast on television and radio. It requires a multimedia approach to disseminating product labeling in connection with broadcast advertisements.
Broadcast media must include a toll-free telephone number, referral to a print advertisement or provision of enough product brochures in convenient outlets, referral to a health care provider and an Internet Web page address.
These avenues satisfy the “adequate provision” requirement of the prescription drug advertising rules, the FDA said.
Prescription drug advertising regulations require that advertisements broadcast over radio, television or through telephone communications systems prominently disclose all of the major risks associated with the drug.
This guidance encourages sponsors to consider the benefits of providing consumers with nonpromotional, consumer-friendly product information in addition to the required product labeling.
Minor revisions in the final guidance include:
- Deleting the option to offer to fax product labeling to consumers;
- Emphasizing the importance of broad dissemination of the print advertisement component of the adequate provision approach;
- Acknowledging that the print brochures alternative component of the adequate provision approach was likely to be feasible only when broadcasting was fairly limited in scope;
- Acknowledging explicitly that health care providers other than physicians and pharmacists can be sources of additional human drug product information; and
- Clarifying the differences in approach for telephone, television and radio advertisements.
Those interested in commenting on the final guidance may contact FDA at the following address: Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20852.
The guidance document and a complete list of frequently asked questions are available on FDA’s Web site: fda.gov/cder/guidance/1804fnl.htm] and fda.gov/cder/guidance/1804q&a.htm.