ANA Files Comments in FDA Rulemaking on TV and Radio Ads

ANA, as part of The Advertising Coalition, has filed comments with the Food and Drug Administration (FDA) in response to its Notice of Proposed Rulemaking (NPRM) on the "major statement" in television and radio ads for prescription drugs.  Our comments address the requirement that the statement of side effects and risks be "clear, conspicuous and neutral."  Specifically, our comments contend that an ad is "neutral" if it neither under warns nor over deters consumers from using a beneficial pharmaceutical product.  Our comments contend that the FDA's criteria that ads "avoid distraction" when the major statement is being communicated is contradictory to its contention that ads present risks in an "unbiased manner."

This rulemaking was required under the Food and Drug Administration Amendments Act of 2007 (FDAAA).  ANA was actively involved in the 2007 legislation to protect the rights of companies to market these important products effectively to consumers.  We hope that our comments on the proposed rule lead to the FDA adopting a standard more in line with our definition of "neutral." 

If you have any questions about our comments, you can reach Dan Jaffe in ANA's Washington office at 202-296-2359 or at