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.

In order to evaluate these conflicting concerns, the FDA proposes a study intended to investigate the impact of limiting the risks presented in DTC prescription drug TV advertisements to those that are serious and actionable, including a disclosure to alert consumers that there are other product risks that are not disclosed in the advertisement.  The FDA hypothesizes that, relative to the inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks.

The notice describes the study design in additional detail and provides responses to those comments from the industry in response to the FDA’s previous request for comments in February 2014 regarding DTC advertisements.

All comments are due by February 12, 2015 and should be identified with: (1) the OMB control number “0910-New” (2) the title “Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads)” and (3) “Docket No. FDA-2014-N-0168.” Comments should be faxed to the Office of Information and Regulatory Affairs, OMG, Attn: FDA Desk Officer, (202) 395-7285, or e-mailed to

Posted by Jennifer K. Shanley

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