FEBM-ASHP collaborate on off-label cancer Rx info

December 15, 2008

Pharmacists hope to speed approvals of off-label medication uses

Key Points

The Foundation for Evidence-Based Medicine (FEBM) and the American Society of Health-System Pharmacists (ASHP), publisher of AHFS Drug Information (AHFS DI), have announced the launch of a collaborative initiative.

The two organizations plan to improve the process for evaluating and publishing evidence for off-label medication uses, particularly for cancer medications.

AHFS DI is recognized by the U.S. Congress as an official record for establishing medical acceptance of off-label uses of drugs.

The partnership between AHFS DI and FEBM follows a user-fee model similar to the Prescription Drug User Fee Act employed by the U.S. Food and Drug Administration (FDA).

This improvement to AHFS DI's evidence-based process allows applicants to submit an application for the consideration of an off-label use of a medication by AHFS DI.

As part of this process, AHFS DI determines on the basis of scientific evidence whether the proposed use of the drug is medically acceptable.

The FEBM-ASHP collaboration is expected to focus primarily on the evaluation of new off-label uses of cancer drugs.

"Increasing the speed of these evaluations is especially important for cancer medications because developments move quickly," said Gerald McEvoy, ASHP assistant vice president of drug information and editor-in-chief of the AHFS DI.

The new process includes information critical to the prescribing decision, including a rating of the strength of the evidence, the grade of the recommendation, and disclosure of any possible conflicts of interest among the committee members, according to a spokesman for ASHP.

This process also will serve to enhance AHFS DI's existing activities to evaluate evidence for off-label use of medications by allowing a formal application for consideration by a petitioning organization.

Applications are submitted to FEBM for consideration of an off-label use and a user fee is paid by the submitter to FEBM.

FEBM has contracted with AHFS DI to perform the determinations as part of its federally recognized compendial activities.

Strict firewall polices are in place between AHFS staff and outside applicants to prevent any undue influence.