The Honorable Charles Grassley
United States Senate, Hart 135
Washington, DC 20510
Dear Senator Grassley,
Our undersigned groups strongly support the Grassley Amendment 2129 to S. 3187, the Food and Drug Administration Safety and Innovation Act. Complete and timely reporting of clinical trial results is crucial not only to patients and their doctors, but also to the future of drug innovation in this country.
The Food and Drug Administration Amendments Act of 2007 established clinicaltrials.gov, a groundbreaking reform that has helped thousands of doctors and patients learn more about clinical trials. But clinicaltrials.gov remains a work in progress, with many information gaps. The Grassley amendment would ensure that the work on clinical trial disclosure begun five years ago in FDAAA is fully implemented and meaningful for both patients, clinicians and the pharmaceutical industry.
It would set a deadline for the National Institutes of Health to finalize regulations governing the disclosure of clinical trial data. And it would ask the Government Accountability Office to evaluate how well that data is being reported, with particular attention to any differences between domestic and foreign data.
Since about 80 percent of clinical trials are conducted outside the U.S., and since the F.D.A. inspects less than 1 percent of all foreign clinical trial sites, and less than 2 percent of all domestic sites, it is crucial that we have better information about the completeness and accuracy of clinical trial data.
Better and more complete data also would encourage innovation and save industry resources by informing companies about clinical trials that were stopped because they caused harm or demonstrated lack of efficacy. This would prevent another company contemplating the same pharmaceutical approach from wasting precious research and development dollars. It would also save prospective patients from harm or, at the very least, false hopes about an effective treatment.
We strongly urge your support for this amendment.
Consumer Federation of America
National Research Center for Women & Families
National Women’s Health Network
Project On Government Oversight (POGO)
Union of Concerned Scientists
For more information, please contact Paul Brown at the National Research Center for Women & Families at (202) 223-4000 or [email protected]