FDA remakes rules on release of off-label drug information

FDA remakes rules on release of off-label drug information

The FDA published its final rules on “Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices” in November, which represents a marked improvement over the draft proposal submitted in June. The regulations on off-label information were mandated by the FDA Modernization Act, passed by Congress in November 1997.

The agency will allow distribution of reprints from peer-reviewed journals listed in Index Medicus, calling them “scientifically sound.” It removes restrictive requirements originally set for the planning, execution, and analysis of the studies involved. There must be clear disclosure at the beginning of the reprint that the article contains unapproved usage of the drug or device.

Special supplements that have been supported in whole or in part by manufacturers are not acceptable. The FDA also noted that it will be difficult for reference books to meet the criteria under the rule, unless they are unabridged and include complete information about a clinical investigation.

And, as noted in an analysis of the final rules by the Coalition for Healthcare Communication, the company representatives who distribute the journal article or reference, cannot discuss the unapproved use. No prepublication material may be distributed.

The Coalition analysis points out that “some particularly onerous provisions of the draft rules were eliminated in the final submission. In all, eight of the criteria for dissemination of journal articles were eliminated.

“We were particularly pleased that the language on permissible articles was changed from `adequate and well controlled’ studies to `scientifically sound’ studies, removing a major obstacle to the use of the provisions.”

The FDA must respond 60 days after submission of the materials. Extensive record keeping required in the first draft has been applied now only to drugs or devices which have new uses with special safety considerations.

Copyright CPS Communications Jan 1999

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