FDA seeks to strengthen direct-to-consumer advertising standards

Print and broadcast prescription drug advertisements may soon provide consumers with clearer more neutral 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 stipulates additional requirements for product disclosure under the Federal Food, Drug, and Cosmetic Act, which is part of the FDA Amendments Act of 2007 (FDAAA).

The FDA requests “that the major statement in DTC television or radio advertisements 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. 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.

These standards are as follows:

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.

Follow the PediatricSuperSite.com on Twitter.