Forthcoming Initiatives At US FDA Viewed By FDLI

With efforts to regulate the US Food and Drug Administration apparently reaching some sort of an end, the agency may raise its marketing and advertising enforcement profile, Wayne Pines, president of Health Care Practice at APCO Associates, has told a meeting of the Food and Drug Law Institute (Marketletter September 16).

The FDA has made clear that there will be no compromise on promotion of off-label uses, as this threatens the basis of the approval process and reduces incentives for approval of additional indications, he said; it remains for the courts to decide where FDA authority ends. But with more direct-to-consumer advertising and over-the-counter switches, the Federal Trade Commission has become more central to industry advertising and marketing.

Agency Seeks Industry Input On Guidance Revision The FDA Division of Drug Marketing, Advertising and Communications plans to reissue all previous guidances in this area, said Division director Minnie Baylor-Henry. She invited industry input on priority placement of old guidances, what new topics should be covered and evaluation of a guidance on promotion of products approved under accelerated approval regulations. A final guidance was issued this month on reprints of pivotal studies; she said Glaxo's approach of reprinting the journal cover and using a disclaimer box highlighting the differences between approved labeling and the reprinted article is a good design; other methods including stickers could also be acceptable.