The FDA is set to issue draft guidance outlining criteria
for dissemination of journal articles on off-label uses, a Congressman has
According to a copy of the draft guidance
posted on the
website of the House Committee on Oversight and Government Reform, the guidance
would set out criteria for allowing drug reps to hand out “truthful and
non-misleading” journal reprints and other publications on unapproved uses of
approved 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 distributing
article 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 he
has several concerns with the guidance, outlined in a letter
commissioner Andrew von Eschenbach, MD, dated last Friday. The congressman is
worried about the enforceability of the criteria and also that manufacturers will use the guidance as a pretext to promote off-label uses of products, sidestepping
the FDA review process and creating “a powerful
disincentive” to conduct clinical trials.
“I recognize this area of the law is complex and that FDA
needs to respect the First Amendment rights of drug and device companies,” Waxman
wrote. “But the draft guidance…would open the door to abusive marketing
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 An FDA spokesperson declined comment on the draft guidance
but told MM&M
the agency “will be responding to the congressman directly
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).