Rep. Waxman and Rep. Markey Push for Public Access to Medical Information

By:  Ed Markey
Date: July 1, 2005
Location: Washington, DC

Lawmakers' legislation will preserve a robust system of research and disclosure

Today Representatives Henry A. Waxman (D-CA) and Edward J. Markey (DMA),
two senior members of the Energy and Commerce Committee, along with 30 other members of the
House announced the introduction of the Fair Access to Clinical Trials (FACT) Act (H.R. 3196). This
legislation will ensure that patients, clinicians, and the public have access to basic clinical trial information
about drugs, biologics, and medical devices.

Recent news reports have indicated that some pharmaceutical companies are not releasing clinical trial
information that raises concerns about their drugs or devices. The lack of mandated full disclosure allows
companies to paint a distorted picture of the safety and effectiveness of drugs and medical devices by
selectively disclosing trial information.

"We cannot continue to allow companies to promote only the positive results of clinical studies and suppress
the negative results," Rep. Waxman said. "The present system can seriously mislead physicians and pose
safety hazards for patients. The Fair Access to Clinical Trials Act creates a publicly accessible clinical trials
database and requires that study sponsors use it."

"Drug companies should not be able to pick and choose which trials they want to disclose and which they
want to hide from the public," said Rep. Markey. "The medical community deserves to have a complete
picture of the safety and effectiveness of drugs and devices."

The "Fair Access to Clinical Trials Act" would establish a mandatory federal clinical trials database. This
legislation would:
· Require sponsors of privately and publicly funded studies of drugs, biologics, or medical devices to
register using a database that builds on the National Library of Medicine's;
· Provide public access to basic information on studies before they begin, such as the disease or
condition with which the trial is concerned, the hypothesis being tested, the sponsor and principal
investigator, and the sources of funding;
· Provide public access to the results of clinical studies, including primary and secondary outcomes
and significant adverse events; and
· Authorize the Secretary of HHS to impose penalties for noncompliance, including revoking a
sponsor's eligibility for further federal funding and imposing civil money penalties.

This Bill has been endorsed by: The Pediatric AIDS Foundation, The National Breast Cancer Coalition Fund,
American Medical Students Association, American Psychiatric Association, American Academy of Child
and Adolescent Psychiatry, Consumers Union, Massachusetts Medical Society, Clinical Social Work
Federation, and US PIRG.

For more information or a bill summary, please visit: or

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