FDA Proposes New Rule for "Major Statement" in Broadcast DTC Ads

The Food and Drug Administration (FDA) has proposed a rule to implement the new requirement that the "major statement" in DTC television or radio ads relating to the side effects and contraindications of a pharmaceutical product be presented in a "clear, conspicuous and neutral manner."  The FDA is also proposing standards that the agency would consider in determining whether the "major statement" in these ads is presented in such a manner.  This new requirement was added by the Food and Drug Administration Amendments Act of 2007 (FDAAA). 

Comments on the proposed rule are due by June 28, 2010.

ANA was actively involved in the 2007 legislation to protect the rights of companies to market these important products effectively to consumers.  We may be filing comments on the proposed rule and need your input. 

Please contact Dan Jaffe (djaffe@ana.net) or Keith Scarborough (kscarborough@ana.net) in ANA's Washington, DC office at (202) 296-1883 with your feedback on this proposal.