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NAEVR Offers Oral and Written Comments at the First Stakeholders Meeting of the NIH/FDA Joint Leadership Council

Legislative Update
June 2, 2010

Left to right:  Dr. Jesse Goodman (FDA), Dr. Kathy Hudson (NIH) and Dr. Vicki Seyfert-Margolis (FDA) led the discussions
Left to right: Dr. Jesse Goodman (FDA), Dr. Kathy Hudson (NIH) and Dr. Vicki Seyfert-Margolis (FDA) led the discussions
Earlier today, the National Institutes of Health (NIH) and Food and Drug Administration (FDA) Joint Leadership Council held its first Stakeholders Meeting. The Council, which was announced on February 24 by Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius, will work to ensure that regulatory considerations form an integral component of biomedical research planning and that the latest science is integrated into the regulatory review process. Chaired by NIH Director Francis Collins, M.D., Ph.D. and FDA Commissioner Margaret Hamburg, M.D., the Council will consist of six senior representatives from each of the two agencies [see NIH representatives below].

Initial remarks were provided by Kathy Hudson, Ph.D., NIH Chief of Staff, and Jesse Goodman, M.D., M.P.H., FDA’s Chief Scientist and Deputy Commissioner for Science and Public Health, with meeting management provided by Vicki-Seyfert-Margolis, Ph.D., Senior Advisor in the FDA Office of the Chief Scientist. Dr. Goodman emphasized the importance of efficiency and effectiveness in the translation of basic research into treatments and therapies, while Dr. Hudson noted this unprecedented opportunity for these two "sister" DHHS agencies to work together. Dr. Hudson stated that this meeting would likely be the first of many with the public.

The purpose of the meeting was to elicit public comments on how the NIH and FDA could collaborate as follows:

  • What steps should be taken to enhance the translation of biomedical research discoveries into new preventatives, diagnostics, therapies or devices for clinical use?

  • What are the priority issues that currently need to be addressed, e.g. clinical trial design, endpoint selection and qualification, bioinformatics needs, to inform on the regulatory review process?

  • How could [NIH/FDA] enhance the exchange of scientific information across all sectors in order to better identify and prioritize scientific areas for emphasis in regulatory research?

  • What mechanisms for the support of regulatory science research would be most effective and efficient in addressing pressing priority areas in the translational pipeline?
In the following open session, medical research advocates representing a variety of disease conditions offered recommendations on how the NIH and FDA could work together to accelerate technologies to prevent, diagnose, and treat diseases. NAEVR, which submitted written comments to the meeting docket, also commented orally on the second question, stressing the importance of the past collaboration between the National Eye Institute (NEI) and FDA. "In its 40-year history, the NEI has had an ongoing collaboration with the FDA on ophthalmic drug and device issues, especially clinical trial design and the identification of new clinical endpoints" said NAEVR Executive Director James Jorkasky. "We need to look no further than 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."

Dr. Hudson announced that the six following NIH Institute Directors would serve on the Joint Leadership Council:

  • Anthony Fauci, M.D. (National Institute of Allergy and Infectious Diseases)
  • Jeremy Berg, Ph.D. (National Institute of General Medical Sciences)
  • Story Landis, Ph.D. (National Institute of Neurological Diseases and Stroke)
  • Thomas Insel, M.D. (National Institute of mental Health)
  • Griffin Rodgers, M.D. (National Institute of Diabetes and Digestive and Kidney Diseases)
  • Susan Shurin, M.D. (Acting, National Heart, Lung and Blood Institute)

Left to right: Medical research advocacy colleagues attending the session included Jennifer Ayers (American Institute for Medical and Biological Engineering), Martha Nolan (Society for Women’s Health Research), and Keith Kerneklian (Coalition for Imaging and Bioengineering Research), who joined NAEVR’s James Jorkasky
Left to right: Medical research advocacy colleagues attending the session included Jennifer Ayers (American Institute for Medical and Biological Engineering), Martha Nolan (Society for Women’s Health Research), and Keith Kerneklian (Coalition for Imaging and Bioengineering Research), who joined NAEVR’s James Jorkasky