American Association for Cancer Research

AACR CANCER POLICY MONITOR

CPM 

                                                                                                       FEBRUARY 2009

FDA ISSUES NEW OFF-LABEL GUIDELINES

 

Pharmaceutical companies may now inform doctors about unapproved drug use

The Food and Drug Administration (FDA) has released new guidelines allowing drug manufacturers to provide information to doctors about off-label drug uses not approved by the FDA. The Guidance for Industry on Good Reprint Practices, released in January, finds the distribution of journal articles on unapproved off-label uses of approved drugs acceptable as long as the materials meet certain criteria for objectivity.

The distribution of literature suggesting unapproved off-label use has stirred controversy over recent years between the drug industry and its critics in Congress. The practice was previously permitted under a legal provision that expired in 2006, and drug manufacturers have since pushed for it to be renewed.

When the FDA released the draft of its off-label guidelines in February 2008, it drew immediate objections from opponents, such as Rep. Henry Waxman (D-CA), who believe the policy jeopardizes public health by creating what they see as a loophole that allows the drug industry to bypass the FDA approval process and promote drug uses that have not received adequate testing.

In its guidelines, the FDA argued that "public health can be served when health care professionals receive truthful and non-misleading scientific and medical information on unapproved uses of approved or cleared medical products."

According to Reuters News, a study published in the Archives of Internal Medicine in 2006 determined that in 2006, one in five prescriptions in the U.S. was written to treat a condition for which the drug was not approved. The researchers also found that most off-label use occurs without scientific support.

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