Guidance for Industry. Consumer-Directed Broadcast Advertisement

Name of Guidance: Guidance for Industry. Consumer-Directed Broadcast Advertisements

Status of Guidance: Final

Date of Guidance: August 1999

Name of Organization: United States Food and Drug Administration (FDA)

Target Audience: This guidance is intended for sponsors who advertise prescription products directly to the public using any electronic communication system.

Laws and Regulations Referenced:

• 21 United States Code (USC) 352 (n) - Requirements for prescription drug advertisements.
• 21 Code of Federal Regulations (CFR) 202.1 (e)(1) – Differences between print prescription drug advertising and broadcast prescription drug advertising.

Definitions:

• Adequate provision – An alternative way for a drug company to provide the drug’s prescribing information.
• Broadcast advertisement - Advertisements that are transmitted through electronic media such as television, radio, or telephone
• Major statement – During commercials, it is the spoken description of the drugs’ most important risks.

Background:

Broadcast advertisements must give a summary of all risks associated with a drug’s permitted uses (adequate provision), and must highlight the drug’s major risks (major statement). This guidance describes how to fulfill the adequate provision requirement.

Summary:

To fulfill the adequate provision requirement, the drug’s sponsor must use a convenient and unintimidating approach for the consumer to obtain more information on the drug. This approach may include:

A. Including a toll-free telephone number in the advertisement which will give consumers more information on the product by having the information read or mailed to them.

B. Let the consumer know where complete printed information can be found, such as an internet address, a magazine article or magazine advertisement.

C. Remind the consumer that more information may be obtained from a physician, pharmacist, or veterinarian (if drug refers to an animal product).

Additionally, if the drug information is broadcasted in a foreign language, all printed informational materials need to be translated to the language of the broadcast advertisement.

Rationale:

The FDA requests this unintimidating approach as a way for consumers to obtain drug related information in a private manner. Furthermore, the agency requests that all printed informational material be translated to the language of the broadcast advertisement because there are many television channels and radio stations that broadcast information in a foreign language particularly in large metropolitan areas.

Resulting Recommendations:

• Simple way of providing prescription drug information to consumers
• Making prescription drug information available in foreign languages

Impact:

• Additional expenses are incurred by the sponsors of prescription drugs in order to comply with this guidance.
• The consumer is better informed and able to make an educated decision on whether to take a particular prescription drug or not.