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DHHS Secretary Sebelius Announces New NIH/FDA Collaboration To Support Efforts in Translational and Regulatory Science

Legislative Update
February 24, 2010

Left to right:  DHHS Secretary Kathleen Sebelius, NIH Director Francis Collins, M.D., PhD., and FDA Commissioner Margaret Hamburg, M.D.
Left to right: DHHS Secretary Kathleen Sebelius, NIH Director Francis Collins, M.D., PhD., and FDA Commissioner Margaret Hamburg, M.D.
Earlier today, Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius was joined by National Institutes of Health (NIH) Director Francis Collins, M.D., Ph.D., and Food and Drug Administration (FDA) Commissioner Margaret Hamburg, M.D. in announcing a new NIH/FDA collaboration “to accelerate and illuminate the pathway from microscope to marketplace.” She acknowledged that the need for enhanced collaboration between NIH and FDA has never been more pressing, given new scientific opportunities in translational research, new public health challenges, far-reaching economic changes at the national and global level, and potential changes to the U.S. healthcare system. She also described the initiative as meeting important goals of the Obama Administration-including harnessing the power of science to benefit all Americans. The collaboration is characterized by the following:
  • The establishment of a joint NIH/FDA Leadership Council, co-chaired by Drs. Collins and Hamburg and consisting of six senior representatives from each agency, to ensure that regulatory considerations form an integral component of biomedical research planning and that the latest science is incorporated into the regulatory review process.

  • A planned Stakeholders Meeting (not yet scheduled) to seek input from interested parties, especially the manufacturer community whose products are regulated by the FDA.

  • The issuance on February 24 of a Request for Application (RFA) entitled Advancing Regulatory Science through Novel Research and Science-based Technologies to support research into regulatory science. Over a three-year timeframe, NIH will commit $6 million and the FDA $750,000 to this initiative, for a total of $6.75 million. Secretary Sebelius noted that the funding is included in the President’s Fiscal Year (FY) 2011 federal budget proposal and represents the first time in which research into regulatory science is funded through that mechanism.
"In its 40-year history, the National Eye Institute (NEI) has had an ongoing collaboration with the FDA on ophthalmic drug and device issues," said NAEVR Executive Director James Jorkasky in comments on the announcement. "Among these are the ongoing series of joint NEI/FDA Endpoints Symposia, including a September 2009 session on Patient-Reported Outcomes, a March 2008 session on Glaucoma Clinical Drug Trial Design, and a November 2006 Ophthalmic Clinical Trial Design session that focused on new treatments for age-related macular degeneration and diabetic retinopathy."