When federal drug regulators approve a medicine for sale, they limit how drugmakers sell it. A drug approved to treat only breast cancer cannot be marketed for lung cancer.
But the Food and Drug Administration proposed guidelines Friday that would change this, and advocates on both sides of the issue say lives are at stake.
The rules would allow drug and device makers to provide doctors with copies of journal articles that discuss product uses that have not been vetted or approved by the FDA. The rules also say that drug companies do not have to promise to adequately test the unapproved use discussed in the article.
Advocates of the new rule say that the FDA is so slow in assessing drug and device benefits that companies need to be able to inform doctors immediately about life-saving uses.
Critics say that drug and device companies have a long history of promoting unapproved drug and device uses that later proved dangerous, and that allowing companies to talk about unapproved uses removes incentives for companies to research adequately whether the new use is beneficial.
"People will die if they are getting drugs that don't have clear evidence that the benefits outweigh the risks," said Dr. Sidney Wolfe, director of Public Citizen's health research group.