View Rule

The Food and Drug Administration (FDA) is amending its regulations concerning direct-to-consumer (DTC) advertisements of prescription drugs. Prescription drug advertisements broadcast through media such as TV and radio directly to consumers must disclose the product’s major risks in what is sometimes called the major statement. The rule would require that the major statement in DTC television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug be presented in a clear, conspicuous, and neutral manner. FDA is also implementing standards that would be considered in determining whether the major statement in these advertisements is presented in the manner required.