The leadership council includes five members from each agency: Anthony Fauci, M.D., director, NIAID; Thomas R. Insel, M.D., director, NIMH; Story Landis, Ph.D., director, NINDS; Griffin P. Rodgers, M.D., director, National Institute of Diabetes and Digestive and Kidney Diseases; Susan B. Shurin, M.D., acting director, NHLBI; Lawrence R. Deyton, M.D., director, Center for Tobacco Products; Dr. Goodman; Karen Midthun, M.D., acting director, Center for Biological Evaluation and Research; Jeffrey E. Shuren, M.D., director, Center for Devices and Radiological Health; William Slikker Jr., Ph.D., director, National Center for Toxicological Research; and Janet Woodcock, M.D., director, Center for Drug Evaluation and Research.
One priority Dr. Goodman identified as an area of interest for the council was to examine how NIH and FDA currently work together and find new ways to partner. While all of FDA’s centers interact with NIH, he said, the agencies should “really pick a few areas where, on levels across the entire NIH and across the entire FDA, we can really make a difference working together.
“An example we’ve discussed a lot is earlier engagement with some of their clinical enterprise studies, so that the results are as useful as possible at the end of the day in impacting medical care and improving the lives of patients,” Dr. Goodman told the FDA’s science board.
Other priorities for the council include:
• Optimizing and maximizing data from clinical trials
• Encouraging the repurposing of products not being used or which have dropped through the commercial development system, such as the repurposing of drugs for orphan diseases
• Developing science to back up the work that the Center for Tobacco Products is going to do: The center’s duties include reviewing premarket applications for new and modified-risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.
“I think it’s sort of astonishing, beyond kind of the basic science of harm, how little science there is about tobacco and its effects. We have heard from Dr. Deyton, the new director of the Center, how important it’s going to be for them as they start getting, for example, lists of ingredients and start trying to find effective ways to reduce harm, to have the science to back it up,” Dr. Goodman told the board.
FDA science board member Garret Fitzgerald, M.D., suggested to the leadership council another area where NIH-FDA cooperation could prove valuable: Applying the convergence of new technologies such as next-generation sequencing, medicalomics, and microbiomics to engage new researchers in food science as well as “provide new tools to those who are interested to begin to ask questions with a degree of precision that was previously unimaginable.”