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Maine to Represent Consumers on Prescription Drug Trial Advisory Group
February 6, 2008
Maine Attorney General Steve Rowe has been asked to represent America’s consumers as part of a national group advising the federal government how to require drug companies to report the results of clinical drug trials on a publicly accessible website.
Maine is the only state with a representative on the federal advisory group. The federal Working Group on Clinical Trials was created by the National Library of Medicine to help it implement a new federal law requiring the public reporting of clinical drug trials. The new law was enacted in September 2007.
“The State of Maine has led the fight to crack the veil of secrecy surrounding prescription drug trials.” Rowe said, “Maine’s national leadership on this issue is the reason the federal group asked us to participate.”
Maine is alone among the states in requiring drug companies to register clinical trials and to post the results on publicly accessible websites.
Maine enacted its law in response to reports that drug companies were not disclosing to prescribers or to the public the results of clinical drug trials that raised questions or cast doubts about the safety or effectiveness of new drugs being used by consumers.
“By having readily available information about the safety and effectiveness of new prescription drugs, Maine people can make better choices about their health care.” Rowe continued.
Under rules jointly developed by the Maine Department of Health and Human Services and the Maine Attorney General, manufacturers must complete by April 1 of this year the posting of results of clinical trials that began after October 15, 2002, for all drugs that are dispensed or administered in Maine. More recent clinical drug trials are already posted on websites; links to those sites can be found on: www.maine.gov/dhhs/boh/clinical_trials.htm
The federal law will create a national standard for the public registration and reporting of results of clinical drug trials. The federal law must take full effect by September of 2010, at which time it will replace Maine’s law.
“By participating in the group, Maine will represent the interests of consumers and states in the meaningful public disclosure of clinical drug trial results.” Rowe added. The federal group will advise the National Library of Medicine on implementing the federal law.
Assistant Attorney General Tom Bradley will represent the Maine Attorney General on the federal advisory group. Bradley is a 1992 graduate of the University of Maine School of Law in Portland and joined the Maine Attorney General’s Office in 2004, where he has worked on many consumer issues involving the prescription drug industry.
January, 2008 David Loughran, (207) 626-8577