Until relatively recently, Direct-to-Consumer (DTC) broadcast advertisements for prescription drugs were rare, in part because drug companies had not been advised by FDA how they could meet the adequate provision requirement for dissemination of the FDA-approved labeling in connection with broadcast ads. In 1999, FDA issued a final guidance document, that described an approach to fulfill the adequate provision requirement for broadcast advertisements. The approach created a loophole that resulted in certain important information being hidden behind 1-800 numbers, print inserts, and websites, rather than being included in the broadcast advertisement.

The proliferation of DTC advertising across television and digital platforms has created potential patient confusion and harm from inappropriate demand for medications, distorting the doctor-patient relationship leading to misalignment of therapeutic choices with actual patient needs, and the misallocation of healthcare resources and government overspending. FDA proposes revising the prescription drug advertising regulation to require DTC ads broadcast through media such as radio and television to disclose all relevant risk and safety information to consumers within the confines of the ad itself rather than referring consumers to an external source where they can request the full FDA-approved labeling. This action does not constitute a ban or unreasonable imposition on DTC drug advertising, but would instead require complete and accurate safety, contraindication, and other risk information in DTC prescription drug advertisements, so that patients and consumers can make fully informed decisions.