FDA ad policy reform supported by ex-FDAers, other former government officials at GWU forum.

Executive Summary

FDA AD POLICY INHIBITS FILING OF SUPPLEMENTS, EX-FDAer Jur Strobos, MD, now with the D.C. firm Greenberg, Traurig, states in a policy paper to be published in January in the Food & Drug Law Institute journal. Strobos, formerly FDA policy research director, notes in a summary of his paper that one rationale offered by defenders of FDA's strict limits on dissemination of off-label use information is that "no company would ever file a supplement for a new indication" if they could claim the new indication in advertising. In fact, Strobos contends, "current policy actually inhibits filing of supplements, unless the potential purchaser that must be targeted can only be reached by direct advertising, because new markets are an avenue for information transfer."