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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA ISSUES FINAL GUIDANCE FOR RX DRUG ADVERTISEMENTS

FDA Veterinarian Newsletter September/October 1999 Volume XIV, No V

The Food and Drug Administration has issued final guidance concerning consumer-directed (direct-to-consumer or DTC) broadcast advertisements for prescription animal and human drugs and human biologicals. The final guidance describes an approach that could fulfill the requirements under regulations to provide consumers general risk information through media such as television, radio, or telephone.

The final guidance will continue a multifaceted approach to disseminating product labeling in connection with broadcast advertisements -- ordinarily containing these four sources: (1) a toll-free telephone number; (2) referral to a print advertisement in a concurrently running print publication, or provision of enough product brochures in various convenient outlets; (3) referral to a healthcare provider (physician, pharmacist, veterinarian or other healthcare provider); (4) an Internet web page address.

As required in the prescription drug advertising regulations, advertisements broadcast over radio, TV or through telephone communications systems must include a thorough "major statement" prominently disclosing all of the major risks associated with the drug. In addition, sponsors of broadcast advertisement are also required to present a brief summary or alternately may make "adequate provisions."

This guidance encourages sponsors to consider the benefits of providing consumers with nonpromotional, consumer friendly product information in addition to the required product labeling. FDA is currently evaluating its regulations as they relate to DTC print promotion and will address this issue in greater detail at a later date.

Minor revisions in the final guidance include:

  • deleting the option to offer to fax product labeling to consumers under the toll-free telephone component of adequate provision.
  • 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 healthcare providers other than physicians and pharmacists can be sources of additional human drug product information. In the case of animal drugs, only veterinarians can provide information.
  • 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

For additional information on direct-to-consumer guidance documents and a complete list of frequently asked questions visit the FDA website.