WASHINGTON, Aug. 4 /PRNewswire/ -- The Association of Clinical Research Organizations (ACRO) welcomes the introduction of S. 3807, “The Enhancing Drug Safety and Innovation Act of 2006.” ACRO applauds the leadership of Senators Michael Enzi (R-WY) and Edward Kennedy (D-MA), the Chairman and Ranking Member of the Committee on Health, Education, Labor and Pensions (HELP), on this important piece of legislation aimed at improving the safety of approved drugs while still providing opportunities for the development of the innovative biomedical products that patients need.
“Representing leading clinical research organizations that have great expertise in the conduct of clinical trials, ACRO provided the HELP Committee with information about the research environment,” commented Executive Director, Doug Peddicord, Ph.D. “We are pleased that the bill recognizes the need to improve the science of clinical trials and the long and costly process of developing new biomedical products.” The Enhancing Drug Safety and Innovation Act provides strong support for the FDA Critical Path Initiative, and would establish the Reagan-Udall Institute for Applied Biomedical Research within the FDA.
Among the key provisions of S. 3807 is a proposal to require a risk evaluation and mitigation strategy (REMS) for most newly approved drugs. A REMS would allow pharmaceutical companies and the FDA to assess and manage potential risks or side effects of a newly approved drug; to identify and assess serious and unexpected risks of the drug; and to better communicate such risks and side effects to physicians and their patients.
By requiring registration of clinical trials and reporting of clinical trial results, the Enzi-Kennedy bill is designed to improve access to information about clinical research and foster better public understanding of the enormous value of clinical trials, as well as the importance of the continuing research that pharmaceutical companies and CROs conduct on drugs that have been approved by the FDA.
“ACRO is supportive of the steps Senators Enzi and Kennedy have taken in their legislation to strengthen what is already a robust system for the development and approval of new drugs,” said Doug Peddicord, Ph.D. “We look forward to joining with our biopharmaceutical customers, research colleagues, legislators and the FDA in order to improve public understanding of and confidence in the research enterprise.”
The Association of Clinical Research Organizations (ACRO) represents the world’s leading clinical research organizations. Its members, which represent more than 70 percent of all CRO revenues worldwide, provide specialized services that are integral to the development of drugs, biologics, and medical devices. ACRO advances clinical outsourcing to improve the quality, efficiency, and safety of biomedical research. For more information, visit http://www.acrohealth.org.
Association of Clinical Research Organizations
CONTACT: Courtney Gray Haupt of Association of Clinical ResearchOrganizations, +1-202-543-4018, courtney.grayhaupt@acrohealth.org
Web site: http://www.acrohealth.org//
