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Senators Introduce Legislation That Would Establish Clinical Trial Registry Database

Posted on: 10/10/2004

Senators Introduce Legislation That Would Establish Clinical Trial Registry Database

09 Oct 2004
Four Democratic senators on Thursday introduced legislation (S 2933) that would require prescription drug and medical device manufacturers to register clinical trials of their products in a public database before they begin testing and then report the results, the New York Times reports.

Sens. Edward Kennedy (D-Mass.), Christopher Dodd (D-Conn.), Tim Johnson (D-S.D.) and Ron Wyden (D-Ore.) sponsored the bill, which has a companion bill (HR 5252) in the House, sponsored by Reps. Edward Markey (D-Mass.) and Henry Waxman (D-Calif.). Health officials and consumer advocates earlier this year called for such a registry after a lawsuit filed by New York Attorney General Eliot Spitzer (D) alleged that an antidepressant manufacturer had misled the public about clinical trial results.

In response, several prescription drug manufacturers, have begun or plan to begin posting information about clinical trials on company Web sites, and the Pharmaceutical Research and Manufacturers of America launched a Web site where manufacturers can post trial results.

AMA backs the legislation, but PhRMA does not, according to the Times. Action on the bill is not expected until after the presidential election (Meier, New York Times, 10/8).


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