Rx-to-OTC switch promotions
This article was originally published in The Tan Sheet
Executive Summary
FDA will address "during the next year" the "difficult regulatory issue" of consumer advertising for drugs that are available both OTC and by prescription for different indications, FDA Policy Development & Coordination Staff Director David Adams told a March 1 Regulatory Affairs Professionals Society meeting in Chicago. Adams explained that there is a "natural tendency" among companies to "promote the relationship between the new OTC product" and the "established prescription product," which can lead to associating "Rx indications with the OTC product." The FDAer suggested that "this undermines the role of the physician in prescribing the Rx product for the Rx indication"