Comments to the FDA on the Presentation of Risk Information in Prescription Drug Direct-to-Consumer Broadcast Ads

November 20, 2017

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Public Citizen submitted comments to the Food and Drug Administration (FDA) pointing out that a study commissioned by the agency to justify its potential proposal to decrease the amount of risk information required to be disclosed in prescription drug direct-to-consumer (DTC) broadcast ads is fundamentally incomplete, flawed, and overly narrow in scope. Public Citizen urged the agency to issue a legally binding final rule regarding DTC broadcast ads that would: 1) maintain its current requirements regarding which risks must be disclosed, while requiring that severe, serious, or actionable risks be disclosed more prominently; 2) require all risk information to be disclosed in both audio and visual formats; and 3) ban the use of distracting imagery and sounds during the disclosure of risk information.

See Public Citizen’s other work on drug promotion.