Under an agreement between the Food and Drug Administration (FDA) and the National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH), the two agencies will share knowledge and resources to facilitate the development of new cancer drugs and speed their delivery to patients.
FDA Commissioner Mark McClellan, and NCI Director Andrew von Eschenbach, said that they will establish a multi-part Interagency Agreement to enhance the efficiency of clinical research and the scientific evaluation of new cancer medications. The planned agreement, to be announced formally at this week's meeting of the American Society of Clinical Oncology in Chicago, will enhance existing programs and add new joint programs to the existing close cooperative relationship between NCI and FDA, both of which are part of the Department of Health and Human Services (HHS).
"This new collaboration between two key HHS agencies means that federal researchers and regulators will be working together more effectively than ever before," said HHS Secretary Tommy Thompson. "The result will be a more unified, integrated, and efficient approach to the technology development and approval process at a critical time for a disease that affects too many lives," Secretary Thompson said.
The agreement offers potential benefits for the more than one million Americans who are diagnosed with cancer each year. "The FDA is committed to finding better ways to get safe and effective treatments to patients with life-threatening diseases as quickly as possible," said McClellan. "At a time when the opportunities to reduce the burden of cancer are greater than ever, sharing tools and resources with our colleagues at the National Cancer Institute will help us fulfill that mission," he said.
"The effort between NCI and FDA in cancer therapies is a prototype that should inform and eventually be applied across all areas of research," said NIH Director Elias A. Zerhouni. "Dr. McClellan and I are committed to NIH and FDA working closely to find innovative ways to more rapidly make the fruits of our discoveries available to the public."
"The collaboration will help the two agencies take full advantage of their combined knowledge base at a time when many new kinds of anti-cancer agents are in the pipeline," said von Eschenbach. "Molecularly targeted drugs and other novel agents offer great promise, but they also present new challenges that require more collaboration between those involved in their discovery and development," he said.
The new partnership is an important step toward NCI's challenge goal to eliminate suffering and death due to cancer by 2015, as well as toward FDA's goals of improving the availability and use of safe and effective treatments for cancer. "The bottom line is that this collaboration holds great promise for getting better cancer drugs to patients sooner," von Eschenbach said. "Our job is to translate the promise of this unique collaboration into real benefit for patients as soon as possible."