Grassley Co-Sponsors Clinical Trial Registry Legislation
Grassley Co-Sponsors Clinical Trial Registry Legislation
Sen. Chuck Grassley today joined Sen. Chris Dodd in introducing legislation that would require drug makers to register clinical trials about prescription medicines. Grassley said that "by making the clinical trial information publicly available we make the system for ensuring drug safety more transparent and more accountable. That ultimately leads to an even safer system and greater consumer confidence." He said his support for a clinical trials registry stems from the oversight work he conducted during the last year regarding the way the Food and Drug Administration has handled information about drug risks. Grassley's scrutiny began based on allegations made early in 2004 about an attempt by the federal agency to withhold information about the findings of an FDA scientist who found a possible link between antidepressants and teen suicide. Grassley continued his investigation of the Food and Drug Administration with a hearing in November to explore the FDA's handling of the painkiller Vioxx, which had been pulled from the market due to increased risks for heart attacks and strokes.
Grassley is chairman of the Senate Committee on Finance, which is responsible for Medicare and Medicaid legislation and oversight. Medicaid has spent more than $1 billion on the drug Vioxx, and Medicare is about to cover prescription drugs for the first time. "There's no doubt that the performance of the FDA affects the integrity and effectiveness of these important
health care programs," Grassley said.
The bipartisan legislation introduced today is titled the Fair Access to Clinical Trials or FACT Act of 2005. It is similar to a measure championed by Dodd in the last Congress. Changes have been made to maintain clinicaltrials.gov as a registry for patients and physicians seeking information about ongoing clinical trials for serious or life-threatening diseases and to require the Food and Drug Administration to make internal drug approval and safety reviews publicly available.
http://finance.senate.gov/press/Gpress/2005/prg022805.pdf