FDA Requires Side-Effect Disclosure in Prescription Drug Ad Rule

Prescription drug advertisements presented in media such as television and radio must disclose the product’s major side-effects and contraindications, the FDA said in a final rule issued Monday.

The Food and Drug Administration augmented its existing authority on prescription drug advertisements through amending its regulations concerning direct-to-consumer ads.

The rule (RIN: 0910-AG27) requires advertisements to present a major statement—a disclosure on a prescription drug’s side-effects and contraindications in a clear, conspicuous, and neutral manner.

The clear, conspicuous, and neutral presentation of risk information in direct-to-consumer TV and radio ads, in addition to benefit information, “helps ensure that these ...