January 20, 2015

FDA submits notice for collection of information regarding direct-to-consumer advertisements

From: Association of Corporate Counsel

Jennifer K. Shanley | Cooley LLP

The Food and Drug Administration (FDA) recently submitted a proposed collection of information on disclosing risks in direct-to-consumer (DTC) prescription drug television (TV) advertisements to the Office of Management and Budget (OMB) for review and clearance.

According to the notice published in the Federal Register on January 13, 2015,prescription drug advertising regulations require that broadcast (TV or radio) advertisements present the product’s major risks, also referred to as the “major statement.” The FDA expressed concern that, as currently implemented in the DTC ads, the major statement is often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic non-compliance due to fear of side effects. However, at the same time, the FDA also recognizes that there is a conflicting concern that DTC TV ads do not include adequate risk information or leave out important information.

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