BRIEF—FDA issues final rule on risk information in Rx drug TV and radio ads

The US Food and Drug Administration (FDA) yesterday issued a final rule to amend its prescription drug advertising regulations, titled “ Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format.”

The final rule implements a statutory requirement for human prescription drug advertisements presented directly to consumers in television or radio format that state the name of the drug and its conditions of use.

These advertisements must present the drug’s major side effects and risk information, known as the “major statement,” in a clear, conspicuous, and neutral manner, the FDA stated.