off label drug use, off label drug marketing, off label drug use fda

Marketing of Off-Label Drug Use Called into Question

July 29, 2008 12:57 PM
by Denis Cummings
The FDA has been criticized for its plan to allow drug companies to provide doctors with information about a drug’s unintended benefits.

30-Second Summary

In a soon-to-be-released report, the Government Accountability Office criticizes the Food and Drug Administration’s lax enforcement of laws preventing the marketing of off-label drug use.

Off-label drug use refers to using FDA-approved drugs in ways not yet approved by the agency. This could refer to using a drug to treat a different disease, giving it to a different type of patient, or prescribing a smaller or larger dose.

The practice is legal and common, representing an estimated 20 percent of all prescriptions. Doctors often base their decisions on articles in peer-reviewed journals and textbooks.

Under current FDA regulations, drug companies cannot provide doctors with literature on a drug’s off-label uses. However, they often do so and the FDA does little to monitor the practice. Even when the FDA catches a drug company—which happened just 42 times between 2003 and 2007—it takes an average of seven months to issue a warning.

In February, the FDA issued new guidelines that would allow off-label drug use marketing with several important requirements. The literature must be published in independent, peer-reviewed journals and textbooks, and cannot include content like abstracts, letters to the editor and Phase 1 trials in healthy subjects.

Proponents of the new guidelines say they allow the FDA to better-regulate a practice that has been tacitly accepted for the last decade. They also point to a 1999 court decision that determined that the restriction of off-label marketing was unconstitutional. The decision was vacated a year later on procedural grounds, but the constitutionality of the issue wasn’t addressed.

Headline Links: FDA proposes new guidelines, GAO to release critical report

Background: The constitutionality of disseminating off-label information

Opinion & Analysis: Should drug companies be allowed to market off-label uses?

Reference: Off-label drug use


Most Recent Beyond The Headlines