Maine first state in nation to require public clinical trials


Monday, June 13, 2005

CONSUMERS UNION – NLARx
Maine first state in nation to require drug companies
make public clinical trials, harmful side effects

Groundbreaking law will help improve drug safety for all Americans

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(Augusta, MA) – Maine has become the first state in the nation to pass groundbreaking legislation requiring pharmaceutical companies make public information about their clinical drug studies, a law that will help ensure patients and doctors know about harmful side effects that often remain hidden from public view, consumer groups said today.
“Giving doctors and researchers access to these studies is one way consumers can be assured that the medicines they take each day are as safe as possible,” said Rob Schneider, manager of the Prescription for Change project at Consumers Union, publisher of Consumer Reports. “As we know from Vioxx and other drugs, we can’t rely on the pharmaceutical industry to voluntarily tell the public about potential problems with their products.”
“Once again Maine is leading the nation in efforts to tackle the high cost of prescription drugs and ensure consumers and doctors have the information they need about the safety and effectiveness of medications,” said Sharon Treat, executive director of the National Legislative Association on Prescription Drug Prices (NLARx), an organization of legislators working to reduce prescription drug costs and expand access. Treat is a former Maine lawmaker.
On Friday, Maine passed LD 1618 that would require drug manufacturers who do business in the state and already are required to report marketing costs under state law to report any clinical trial conducted or sponsored after Oct. 15, 2002. The reporting method would have to be approved by the state’s health department, and would include 1) the name of the entity conducting the trial; 2) a summary of the trial’s purpose 3) dates the trial is taking place and 4) information concerning the trial results, including potential or actual adverse effects of the drug.
Because the law covers any company that sells drugs in Maine, it is expected that the bulk of drug company studies would be made public under the law. “This law ultimately will help improve drug safety for all Americans,” Schneider said.
At least 15 states this year introduced legislation that would require public registry and disclosure of all clinical drug trials. And a bipartisan bill is pending in the U.S. Senate sponsored by Senators Charles Grassley (R-Iowa) and Christopher Dodd (D-CT) that would require all drug study results be registered and results made public on a federal government Web site.
“Maine may be the first such state law to pass this important law, but it won’t be the last,” Treat said. “State legislators across the country are concerned about the impact of pervasive, misleading advertising and the lack of candor by drug companies about clinical trial results.”
For more information contact:
Susan Herold, 202-462-6262, CU
Sharon Treat, NLARx, 207-622-5597