FDA would let drug makers tip doctors to other uses

Health regulators on Friday issued draft guidance that would make it easier for pharmaceutical companies to advise doctors about unapproved uses for their medicines.

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

Drug makers by law are prohibited from marketing their drugs 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.

Representative Henry Waxman, chair of the House of Representatives panel on oversight and government reform, last year protested an internal draft of the proposal, which he said could “carve a huge loophole in the law.”

Waxman and other critics say that allowing the practice would promote untested uses of drugs and would be dangerous for patients.

Moreover, if drug makers can promote products in this way, it discourages them from conducting clinical trials for new uses, critics say.