FDA Proposes Drug Side Effects Be Presented More Clearly in TV, Radio Ads

The Food and Drug Administration proposed March 29 that the major statement in direct-to-consumer (DTC) television or radio advertisements relating to the side effects of an advertised prescription drug be presented in a “clear, conspicuous, and neutral manner.”

The proposed rule, published in the Federal Register (75 Fed. Reg. 15,376), would augment FDA’s existing authority by requiring television and radio advertisements for human prescription drugs to present the major statement (the disclosure of the major side effects and contraindications of the drug) in a clear, conspicuous, and neutral manner, regardless of the manner in which effectiveness ...