FDA Takes First Amendment Issues "Seriously"

Several legal cases have challenged the Food and Drug Administration’s approach to regulating industry communications about medical products, and agency officials now are acknowledging the importance of addressing these developments head-on. In the wake of U.S. v. Caronia and IMS v. Sorrell, the spotlight is on speech-related activity, including product labeling and advertising and promotion of regulated products, said FDA chief counsel Elizabeth Dickinson, at last month’s Food and Drug Law Institute (FDLI) annual meeting. And, she added, “the agency is taking these first amendment concerns very seriously.” 

Similarly, Leslie Kux, head of FDA’s Office of Policy, included “consumer information” on her short list of priority regulatory concerns. FDA is examining how off-label communications relate to a number of key issues for pharmaceutical marketers, including handling of unsolicited requests, involvement in scientific exchange, providing health-care economic information, communications with formulary committees, and clinical practice guidelines developed by third parties. While FDA continues to examine multiple comments on its draft guidance on unsolicited requests, it also seeks comments on scientific exchange issues and is drafting guidance on healthcare economic information, which Kux hopes may appear “soon.”

And Janet Woodcock, director of the Center for Drug Evaluation and Research, cited drug advertising and promotion as one of many critical activities for CDER to tackle. “We are currently carefully evaluating our policies in light of court decisions on first amendment issues,” she said, citing continued work on draft guidances on disseminating reprints that address unapproved uses, company use of interactive promotional media, and product name placement in the media.

Jacobson acknowledged a new commitment to “realign FDA regulatory posture in this area.” An over-arching issue is what level of substantiation for safety and efficacy information is needed outside approved labeling. Agency staffers are examining factors that make off-label information misleading; whether disclosure of the off-label status of information is helpful; and what opportunities should be supported to streamline labeling requirements.