While several inaccuracies in the recent opinion piece about direct-to-consumer prescription drug advertisements by KFF Health News’ Elisabeth Rosenthal have been corrected in response to FDA’s direct requests, in this letter the FDA seeks to provide additional information about the agency’s oversight to readers and correct any misimpressions that may remain (“ ,” Sept. 9). The FDA is strongly committed to protecting public health by ensuring prescription drug promotion by or on behalf of a drug manufacturer, distributor, or packer is truthful, balanced, and accurately communicated.
Federal law has long required prescription drug advertisements to present a true statement regarding the side effects, contraindications, and effectiveness associated with the advertised prescription drug (with information relating to major side effects and contraindications referred to as the “ ” in TV or radio ads). This requirement has been in place for many decades and helps to ensure a truthful and non-misleading presentation of information about the prescription drug, as well as a balanced presentation of safety and efficacy information. In 2023, the FDA issued a establishing five standards to help ensure that the major statement in ads for human prescription drugs in TV/radio format is presented to consumers in a clear, conspicuous, and neutral manner.
The aforementioned article suggests it is unclear how to determine whether an advertisement complies with this rule. However, .