FDA to Act on “Titillating” Drug Ads?
 
March 31, 2005
 

In 1997 the Federal Food and Drug Administration (FDA) proposed guidance clarifying how drugs reasonably may be advertised over broadcast television.  So-called DTC (Direct to Consumer) ads have since proliferated, and indeed the FDA has emphasized the consumer benefits of such ads, including increasing patient awareness, stimulating doctor visits, and helping to identify previously undiagnosed conditions (see three draft guidances released for comment just last year; 69 Fed. Reg. 6308 (2004)).  It would seem that such ads would enjoy broad First Amendment protection.  But in an era of increasing concern over health care costs, as well as sensitivities about the appropriateness of various themes and language in broadcast ads, some drug ads have come in for particular scrutiny. 

Recently, FDA Acting Commissioner Lester Crawford, who is also the Administration’s nominee for the permanent post, has publicly expressed concern about ads for erectile dysfunction drugs, suggesting that there might be something FDA will do, presumably in the form of an enforcement action against one or more manufacturers.  If FDA acts, it will be interesting to see what the basis may be.  Over-treatment is generally not the problem with FDA-regulated products; indeed, under-diagnosis and under-treatment remain serious problems that FDA has shown can be helped with DTC.  The focus of any action is likely to be on whether particular ads are truthful and not misleading, and adequately address risks and warnings.

For more information, e-mail Matt Van Hook at matt.vanhook@hklaw.com or call toll free, 1-888-688-8500.