Scandal, Intrigue on Drugs: Now More Uses Than Ever
- added March 10, 2008
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The FDA seeks to broaden the range of use for drugs
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.
But 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 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.
But 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.”
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