Maine to Require Drug Cos. to Disclose Trial Info

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Maine to Require Drug Cos. to Disclose Trial Info

CHICAGO (Reuters) Jun 14 - The U.S. state of Maine is poised to enact a

law requiring drugmakers to make clinical trial data on their drugs

available to the public, amid concern about drug safety after several

high-profile drug withdrawals.

Maine will be the first state in the nation to demand more disclosure

from drugmakers after several prescription drugs were pulled from the

market including Merck & Co. Inc.'s painkiller Vioxx and Biogen Idec

Inc.'s Tysabri.

Before these drugs were pulled, hints of serious adverse events were

seen in earlier studies.

Drug companies are not required to submit all clinical trial data to

the U.S. Food and Drug Administration and industry critics say they

omit unfavorable results.

Maine's legislature approved the bill last week, and a spokeswoman for

Democratic Governor Baldacci on Monday said he will sign it into

law.

Under the law, any drugmaker doing business in the state must report

any clinical trial conducted or sponsored after Oct. 15, 2002,

including the trial's purpose, dates, results and adverse events.

Supporters say any company that sells drugs in Maine will be covered

under the law.

The drug industry in general has agreed to disclose more data but

supports a voluntary system. A spokeswoman for the pharmaceutical

industry's trade group, Pharmaceutical Research and Manufacturers of

America, did not have an immediate comment.