FDA Weakens Off-Label RulesJan 3, 2009 | Parker Waichman LLP, LLP
The U.S. Food & Drug Administration (FDA) has loosened its rules regarding the promotion of off-label drug uses. According to Reuters.com, drug makers will now be allowed to "advise" doctors of possible unapproved uses of their drugs by distributing journal articles that discuss such uses. The rule change is already drawing fire from critics of the FDA.
Off-label use is defined the use of a drug in a way that has not been evaluated by the FDA for approval. Once a drug has been approved, doctors are allowed to prescribe it in anyway they see fit - even unapproved uses. But drug makers have been barred from touting off-label uses. However, there has been disagreement as to whether that prohibition should extend to the distribution of medical journal articles that discuss unapproved uses. Guidelines regarding the distribution of such articles expired in 2006, and the FDA has been mulling changes ever since.
According to Reuters, the new FDA guidelines will now make it far easier for drug makers to distribute such articles to doctors. In announcing the guidelines, the FDA said "public health can be served when health-care professionals receive truthful and non-misleading scientific and medical information on unapproved uses."
But critics of the FDA say the new guidelines are too lenient and endangers patients. According to the Associated Press, many are disturbed that drug makers will not have to submit articles to the FDA for review before they can be distributed. The rules that expired in 2006 had such a requirement.
Rep. Henry Waxman (D-Calif), a frequent FDA and drug industry critic, also questioned the timing of the rule change. "In the final hours of this administration, political appointees at FDA have given drug companies a long-coveted parting gift," Waxman told the Associated Press. "This fundamentally undermines the requirement that companies prove to FDA that each new use is safe and effective."
According to a report on MMMonline.com, the guidance does come with some restrictions. Any articles distributed to doctors must be kept separate from promotional materials. The articles also cannot be discussed between sales reps and doctors during sales calls. Reprints can be distributed at medical or scientific conferences "in settings appropriate for scientific exchange," but not "in promotional exhibit halls or during promotional speakers' programs."
The articles also must come only from peer reviewed journals, and they cannot be false or misleading. Certain types of articles, including those published primarily for distribution by the manufacturer are off-limits, as are letters to the editor, abstracts, reports of Phase 1 trials in healthy subjects or reference publications that contain little or no substantive discussion, are not allowed, MMMonline said.
The Web site also reported that information in the articles distributed must be unabridged and cannot be marked, highlighted, summarized or otherwise manipulated by the manufacturer. The reprints must also be accompanied by a “prominently displayed and permanently affixed statement” noting that the uses discussed are unapproved by FDA and any financial ties between the manufacturer and the study's authors, said the guidance, MMMonline said.