The FDA’s New Guidance for Off-Label Promotion Is Only a Start

Abstract

As has been reported widely in the press and in the February 2008 issue of P&T, the Food and Drug Administration (FDA) has proposed new rules to guide the pharmaceutical industry in promoting off-label uses of drugs.1 Known as “Good Reprint Practices,” the document lists conditions under which sales representatives may distribute reprints of journal articles describing drug indications that the agency has not approved.2 The draft was issued on February 15, 2008, and a 60-day period was allowed for comments before its formal adoption.

This is a highly contentious area, and the arguments on both sides have already started to fly from the public, the press, and members of Congress. A tremendous amount is at stake, both financially and clinically, because more than 20% of overall prescription drugs in the U.S. and close to 50% of products in some specialties are used in an off-label manner.3

The debates over restrictions on off-label promotion of products may seem arcane to those outside of the pharmaceutical industry, but these discussions get to the heart of pharmaceutical marketing practices and the role of FDA oversight. For this reason, it is important to understand both points of view. The ultimate resolution will determine much more than the kinds of paper that can fill a physician’s inbox.