FDA finalizes DTC ad rule 13 years after posting proposal, creating new standards for TV and radio

Fierce Pharma November 21, 2023
Nick Paul Taylor

The FDA is finally finalizing its rule on the need for direct-to-consumer (DTC) ads to present side effects and contraindications “in a clear, conspicuous and neutral manner” more than 10 years after closing the third and final comment period.

In 2010, the FDA proposed changing its regulations on DTC ads that run on TV and radio to address the Food and Drug Administration Amendments Act requirement for the “major statement relating to side effects and contraindications [to] be presented in a clear, conspicuous and neutral manner.” The FDA ran one comment period in 2010, and two after the release of a study of viewers’ understanding in 2012.

Then, public signs of progress stopped. In its final rule, the FDA...

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