The FDA is set to issue draft guidance outlining criteriafor dissemination of journal articles on off-label uses, a Congressman hasfound.
According to a copy of the draft guidance posted on thewebsite of the House Committee on Oversight and Government Reform, the guidancewould set out criteria for allowing drug reps to hand out “truthful andnon-misleading” journal reprints and other publications on unapproved uses ofapproved drugs and devices to healthcare professionals. Among other criteria, the articles must be published by an organization with an editorial board and must be peer-reviewed.
However, the new rules would eschew a requirement contained in the old safe harbor on distributingarticle reprints, which lapsed in September 2006, requiring drug makers to submit articles to the FDA before sending them to professionals.
Rep. Henry Waxman (D-CA), chair of the committee, said hehas several concerns with the guidance, outlined in a letter to FDAcommissioner Andrew von Eschenbach, MD, dated last Friday. The congressman isworried about the enforceability of the criteria and also that manufacturers will use the guidance as a pretext to promote off-label uses of products, sidesteppingthe FDA review process and creating “a powerfuldisincentive” to conduct clinical trials.
“I recognize this area of the law is complex and that FDAneeds to respect the First Amendment rights of drug and device companies,” Waxmanwrote. “But the draft guidance…would open the door to abusive marketingpractices.”
Waxman set a deadline of Dec. 21 for the FDA to respond to his policy concerns and asked them to delay issuance until then. An FDA spokesperson declined comment on the draft guidancebut told MM&M the agency “will be responding to the congressman directlywith comment.”
Sheldon Bradshaw, FDA’s former chief counsel, had advised companies earlier this year that they may rely on the previous safe harbor, a provision in the 1997 FDA Modernization Act which sunsetted last year, until new guidance on off-label rerprints arrives (MM&M, March 2007).