New rules for off-label uses

August 1, 1998

Pharmaceutical Representative

The Food and Drug Administration proposed new rules that will provide pharmaceutical companies more latitude in promoting off-label uses of medicines, biologics and medical devices.

The Food and Drug Administration proposed new rules that will provide pharmaceutical companies more latitude in promoting off-label uses of medicines, biologics and medical devices.

If the rules are finalized and implemented as a provision of the FDA Modernization Act of 1997, sales reps will be empowered to share information such as peer-reviewed journal articles about off-label uses with health care practitioners, pharmacy benefit managers, health insurance issuers, group health plans and state and federal agencies.

In the past, pharmaceutical companies had to wait until the FDA approved a supplemental application before they could disseminate even reliable information about unapproved uses.

The new rules specify that off-label, unapproved information can only be disseminated under certain conditions: Companies must study the unapproved uses and have submitted, or made plans to submit, applications for formal FDA approval, and the information must be reliable and balanced. It may be an unabridged reprint or copy of a peer-reviewed scientific or medical journal article, or an unabridged reference publication about a clinical investigation that is considered scientifically sound.

The unapproved uses must not pose a significant risk to the public health, be false or misleading or have been derived without permission from clinical research conducted by another pharmaceutical manufacturer. Companies must also include certain disclosures with the information, including official labeling, a bibliography of other articles pertaining to the new use and a statement indicating that the new use has not been approved by the FDA.

To keep pharmaceutical companies motivated to acquire official FDA approval, companies will also have to submit a copy of the information to the FDA within 60 days prior to disseminating the information. PR