FDA mandates trials in off-label regulations

Action part of Modernization Act of 1997

Mandating clinical trials and scientific literature from drug makers who disseminate off-label information about their products, the U.S. Food and Drug Administration has finalized off-label guidelines that were part of the Con gressional FDA Modernization Act passed two years ago.

The act eliminated pharmacists from the health care and government groups eligible to receive the information. The FDA limited direct dissemination to groups like physicians who prescribe and pharmacy benefit managers and group health plans that cover prescription drugs. The regulations state that drug manufacturers can disseminate off-label information electronically or on paper as long as they are pursuing approval for the usage and are pursuing clinical trials.

FDA has 60-day jump on reviews

If clinical studies have been completed, manufacturers must submit a new drug application within six months of the dissemination of off-label material. The FDA allows them 36 months if trials are still being done.

The FDA requires an exact copy of the off-label material and demands a 60-day waiting period after the agency receives the material before anyone else can get it. The information must report on a clinical investigation of the off-label usage and must be in the form of an unabridged reference publication or unabridged reprint or copy of a peer-reviewed article that can be found in Index Medicus. Material funded by the drug maker is not allowed, and disclosure of any financial interest by any author also must be made clear to the agency. Letters to the editor, abstracts, and basic Phase I reports without clinical observations or discussion is not allowed.

Further, the materials must state that the information concerns usage not approved by the FDA and must include complete product labeling and a bibliography. As with most FDA regulations, filing exemptions are included, as is the agency’s authority to revoke off-label information under an array of situations.

[For details, call the FDA’s division of drug marketing, advertising and communications at (301) 594-6822 or visit its Web site at http://www.fda.gov.]