WASHINGTON — The Food and Drug Administration is considering whether to loosen rules on how easily drug makers can pass out information that highlight so-called "off label" uses of drugs.
The FDA said the move could allow drug makers to share information about medical treatments that could help doctors better treat patients. Critics of the proposal, however, say it will open the door to allowing drug makers to push their products in ways that have never been approved by the FDA — some of them potentially harmful.
While doctors are free to prescribe drugs for any reason they see fit, drug makers have long been prohibited from actively marketing any uses not specifically approved by the FDA.
After 1997, drug makers could pass out some medical journal articles that highlighted potential new uses for drugs. But that ability was restricted to articles submitted beforehand to the FDA and for uses that the company planned to seek formal approval. The law covering that policy recently expired.
In a new proposal, the FDA said it would allow drug makers to hand out medical journal articles without submitting them beforehand to the FDA. And they no longer would have to promise to seek formal approval for such uses. The articles would have to meet other quality standards.
The FDA is accepting comments on the new proposal for 60 days.
Sidney Wolfe, the director of Public Citizen's Health Research Group, an advocacy organization, said the proposal "constitutes a health threat because it encourages drug companies to promote drugs for purposes not proven to be safe and effective, and it provides an assurance the FDA will not take sanctions against them."
The industry's main trade group, Pharmaceutical Research and Manufacturers of America, said it is still reviewing the proposal, but that off-label uses are often the recognized standard of care for certain conditions, such as cancer.
McClatchy Newspapers 2008