Maine first state in nation to require drug companies...

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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

 

 

(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

PrescriptionforChange.org, a project of 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

 

 

 

 

 

 

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