F.D.A. Seeks to Broaden Range of Use for Drugs

When federal drug regulators approve a medicine for sale, they limit how drug makers sell it. A drug approved to treat only breast cancer cannot be marketed for lung cancer even if some studies suggest that the medicine may save lung patients. But the Food and Drug Administration proposed guidelines Friday that would change this, and advocates on both sides of the issue say that lives are at stake. The rules would allow drug and device makers to provide doctors with copies of medical journal articles that discuss product uses that have not been vetted or approved by the F.D.A. The rules also say that drug companies do not have to promise to adequately test the unapproved use discussed in the article.

Critics of the proposal 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 such unapproved uses removes incentives for companies to research adequately whether the new use is actually 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. Representative Henry Waxman, Democrat of California, said the proposed rule “caters to the industry’s desire to market their products without adequate testing or review.”

The F.D.A. will accept comments from the public on the proposal and take it up for final consideration in 60 days. The reason for this debate is that doctors are not overseen by the F.D.A. Medicine is regulated by state medical boards, which generally let doctors prescribe drugs and devices as they see fit regardless of F.D.A. judgments.

Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, said the rule would stop companies from underwriting expensive trials to confirm new drug uses. “Companies could openly promote products for unapproved indications without testing these drugs,” he said. “I’m astonished that this rule would even be considered.”

Steve - we are as astonished as Dr. Nissen. Well, not really. Every day it is still painfully apparent that the FDA is run by Big Pharma. Why should we expect the FDA to do the right thing?

Just make sure that if you are prescribed a medication, it is approved for the purpose you are supposed to be taking it for. Otherwise, you are a guinea pig for substances with no history of possible side effects.