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FDA proposes drug companies meet key direct-to-consumer advertising standards

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Consumers may soon find advertisements for prescription drugs to be broadcast or published in a clearer and more neutral manner in terms of providing information about contraindications and possible side effects under a proposed FDA rule.

If accepted, the proposal (21 CFR Part 202), which was published in the Federal Register on March 29, would affect all direct-to-consumer (DTC) broadcast media ads for drugs, as well as parts of any advertisements that use both textual and audio communication.

The proposal would provide an added requirement under the of the Federal Food, Drug, and Cosmetic Act added by the FDA Amendments Act of 2007 (FDAAA), which required drug companies to disclose clearly and neutrally in their DTC ads the effectiveness, contraindications and risk of their products.

The FDA proposal requests “that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. The FDA is also proposing, as directed by FDAAA, standards that the agency would consider in determining whether the major statement in these advertisements is presented in the manner required by FDAAA,” according to the Federal Register posting.

Standards being considered

In the proposal, the FDA recommends the following four standards that “major statements” in DTC drug ads must meet in order to be acceptable:

• Information must be presented in language readily understandable by consumers.
• Audio information must be understandable in terms of volume, articulation and pacing used.
• Textual information should be appropriately placed and presented against a contrasting background for sufficient duration and its size and font style must allow the information to be read easily.
• The ad should not include any distractions, including statements, text, images, sound or combinations thereof that might detract from the major statement being clearly communicated.

The FDA will accept all comments concerning the proposal through June 28. After that date, DTC ads broadcast on television or radio would be required to comply with the new standards.

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