Resources for Food and Drug Administration (FDA)

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

www.nytimes.com

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.

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