From: Reuters
Published February 15, 2008 05:20 PM

FDA would let drug makers tip doctors to other uses

By Kim Dixon

WASHINGTON (Reuters) - Health regulators on Friday issued proposed guidelines that would make it easier for pharmaceutical companies to advise doctors about unapproved uses for their drugs.

The Food and Drug Administration plans to let drugmakers such as Pfizer and Merck & Co distribute medical journal articles to doctors and other health professionals, a controversial area of promotion.

By law, drug makers are prohibited from marketing their medicines for uses not approved by the FDA. But doctors can prescribe drugs for uses beyond approved indications, a practice known as "off-label" use.


Distribution of medical literature suggesting a drug may have merit for a use not yet FDA-approved has been a marketing area in dispute for years.

"Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," Randall Lutter, the FDA deputy commissioner for policy, said in a statement.

The public has 60 days to comment on the proposal.

Critics said that allowing the practice would promote untested uses of drugs and would be dangerous for patients. It could also deter drug makers from conducting clinical trials for new uses.

Representative Henry Waxman, chairman of the House of Representatives Oversight and Government Reform Committee, said the guidance was great news for the drug industry but terrible for the public health.

"It caters to the industry's desire to market their products without adequate testing or review," Waxman said in a statement.

Dr. Steven Nissen, a frequent FDA critic and chairman of cardiovascular medicine at the Cleveland Clinic, said "a journal article is not an acceptable replacement for the careful regulatory review of products for new indications."

Officials at the Pharmaceutical Research and Manufacturers of America industry group were not immediately available for comment.

Drugmakers typically must conduct multiple studies with data on hundreds to thousands of patients before getting approval from the FDA.

The agency said only peer-reviewed articles published by a group with an editorial board could be distributed to doctors, and all conflicts of interest and author bias should be clearly disclosed.

The agency also retains the right to determine whether an article fits the criteria.

Diane Dorman, a vice president at the National Organization for Rare Disorders, said her group supports the proposal, because "there is very little information out there about rare diseases."

(Reporting by Kim Dixon; Editing by Tim Dobbyn)

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