To increase transparency and consumer awareness, the Food and Drug Administration (FDA) issued a final rule to amend its regulations regarding direct-to-consumer (DTC) advertisements for prescription drugs in television and radio formats. Additionally, one month later in December 2023, FDA issued a final guidance document complementing the rule, which is intended to help entities understand and comply with the standards established in the final rule.
More on Rule and Guidance
The final rule, implemented as part of the Food and Drug Administration Amendments Act of 2007, establishes five key standards aimed at presenting the “major statement” in a DTC advertisement in a clear, conspicuous and neutral manner. The final rule does not affect the content of a major statement. For example, information regarding the major side effects and counterindications. Rather, it focuses on the consumer accessibility of that information.
Tags: Advertising Drug Policy FDA New Drug Trend
