FDA Final Rule on Direct-to-Consumer Prescription Drug Advertisements

The U.S. Food and Drug Administration (FDA) recently published a final rule amending “its regulations concerning direct-to-consumer (DTC) advertisements for human prescription drugs presented in television or radio format and stating the name of the drug and its conditions of use.”  The final rule implements a requirement of the Food and Drug Administration Amendments Act of 2007 (Pub. L. No. 110-85, September 27, 2007, codified in 21 U.S.C. 352(n)), and establishes standards to determine, that in “DTC TV/radio ads, the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner.”  The major statement must be “presented in consumer-friendly language and terminology that is readily understandable,” and its audio information must be “at least as understandable as the audio information presented in the rest of the ad.”  In TV ads, information must be “presented concurrently using both audio and text (dual modality)” and “the information in text is formatted so the information can be read easily.”  For additional information, see 88 Fed. Reg. 80958 (November 21, 2023).