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FDA/Industry Guidelines for Disclosure

Ann's NOTE: In 1997 Congress authorized disclosure of clinical trials. Pharmaceutical companies have resisted. Now FDA is establishing their guidelines for disclosure. Many patient/advocates have wondered why industry will not reveal these trials.

It is our contention that the competitors know what is going on, it is only the patients who do not find out this information in a timely fashion. This will facilitate the sites that offer clinical trial information and should mean that ALL trials will be listed, not just the subset that industry has revealed.

This will be better for patients, we hope.



The US Food and Drug Administration is also expecting significant changes in how much information on clinical trials is made available to the public by private drug companies. According to Terry Toigo, director of the agency's Office of Special Health Issues, the FDA will soon release final industry guidelines designed to bring drug companies into compliance with a 1997 law requiring disclosure of all clinical trials for drugs designed to treat a serious or life-threatening disease.

The FDA was prevented from distributing information on drugs that had not yet been approved for public use in the past, but the new legislation allows the agency to help coordinate the effort, she said. The so-called ''one-stop shopping'' measure for experimental drug trials should help consolidate information for doctors, patients, and their families, said Toigo.

As private drug makers come into compliance, thousands of clinical trials will be added to a database maintained by the National Institutes of Health, located at www.clinicaltrials.gov.

Toigo said the FDA is encouraging private drug makers to work with doctors and cancer advocacy groups to determine which patents are best-suited for certain experimental therapies.Boston Globe,

3/21/02


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padIndustry Influence on Federal Advisory Committees
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Press Release, 3/03 Center for Science in the Public Interest
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padLetter to Dr. Lester Crawford, FDA Acting Commissioner
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March 10, 2005 We are signees
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Excerpt on April, 2005 decision to approve Mentor implants
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