Lawmaker Led Effort to Reform Clinical Trials As Part of Recently Enacted FDA Overhaul

WASHINGTON, D.C. –A new Inspector General (IG) report set to be released today uncovers a dangerous lack of oversight by the Food and Drug Administration (FDA) of clinical trials run by drug companies. Representative Edward J. Markey (D-MA), author of the new federal clinical trial registry and results database, responded with alarm to the report, noting that the lack of oversight means that millions of Americans may be participating in drug trials that do not conform with basic safety and ethical standards.

“It is outrageous that, in many ways, clinical trial participants have been treated worse than guinea pigs – deprived of robust protections and safeguards. We must ensure that proper safety and ethical protocols are being followed to protect all participants in drug research” said Rep. Markey.

The Department of Health and Human Services IG’s report finds that a lack of information, oversight authority and proper organization led to a situation where the FDA inspected only 1 percent of clinical trial sites between 2000 and 2005. According to the IG’s report, the FDA is currently unable to identify all clinical trials and Institutional Review Boards, (entities that are supposed to ensure that trials meet ethical standards). The FDA also lacks a single database for tracking its own inspections and has been using outdated guidance and regulations that do not reflect current clinical trials practices.

The IG report recommends developing a clinical trial database (which the new FDA reform law that Rep. Markey co-authored, P.L. 110-85, just established), creating a registry of the institutional review boards that oversee trials and giving the FDA more authority to oversee clinical trial sites.

“The new federal mandatory registry of all clinical trials which I co-authored and which was signed into law yesterday, is an important first step in protecting trial participants. But the FDA needs to do more than just know where and when trials are being conducted. The FDA needs more authority to oversee clinical trials and to step up its inspections and enforcement to protect participants in clinical trials, otherwise millions of participants will continue to be put at risk in possibly unethical or hazardous trials,” added Rep. Markey.

Rep. Markey wrote and negotiated several drug safety provisions in the FDA reform law, P.L. 110-85, based on provisions from H.R. 1561, a bill he introduced with Rep. Henry Waxman (D-CA) earlier this year. Key among those provisions was the creation of a mandatory clinical trials registry and results databases housed at the National Institutes for Health to be available online. The registry will contain vital information for consumers interested in enrolling in clinical trials. The results database will ensure that the findings produced from clinical trials are made public so that companies do not game the system and make their drugs appear safer or more effective than they actually are.


September 28, 2007

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