The FDA issued a final rule Nov. 21 that will require drugmakers to clearly state side effects and contraindications in direct-to-consumer advertisements. The rule is effective May 20, 2024.
The rule specifies five standards that drugmakers should follow to ensure consumer ads for prescription drugs meet this requirement, referred to as the "major statement":
1. Information must be presented in "consumer-friendly language and terminology that is readily understandable."
2. Audio information must be "at least as understandable as the audio information presented in the rest of the ad" when going over risks and contraindications.
3. For TV ads, the audio portion of the major statement must be presented alongside a text version "for a sufficient duration to allow it to be read easily."
4. The format of the text in TV ads must be formatted "such that the information can be read easily."
5. Advertisements must not include audio or visual elements that could interfere with the major statement.
"This final rule complements the longstanding requirements for including risk information in prescription drug ads, setting standards for the manner of presentation of the major statement of side effects and contraindications in [direct-to-consumer] TV/radio ads to help ensure that this risk information is presented effectively — that is, in a way that helps consumers notice, attend to, and understand the drug's risks," the agency said in the rule.