Medical product research, approval get new push from NIH, FDA

Besides offering an expedited process, the agencies' new council hopes to improve the safety, efficacy and quality of new treatments.

By Chris Silva, amednews staff. Posted March 12, 2010.

Washington -- The National Institutes of Health and the Food and Drug Administration have announced a new joint effort to accelerate the regulatory review process and streamline biomedical research in the hopes of getting new medical products to market more quickly.

On Feb. 24, the agencies announced the formation of an NIH-FDA Joint Leadership Council to spearhead collaborative work on public health issues. The council's mission will be to help ensure that the latest science is integrated into the regulatory process. The NIH and the FDA will jointly issue a request for applications, making $6.75 million available over three years for work in the field of regulatory science.

The council's formation is necessary because although remarkable advances in biomedical sciences have been made over the years, more progress can be made in reducing the time it takes for a new scientific discovery to translate into needed treatment for patients, said Health and Human Services Secretary Kathleen Sebelius.

"Collaboration between NIH and FDA, including support for regulatory science, will go a long way toward fostering access to the safest and most effective therapies for the American people," Sebelius said.

While the two agencies have teamed up before on health initiatives, the council represents the most extensive cooperative use of their respective capabilities, said Francis S. Collins, MD, PhD, NIH's director. The collaboration "is the first of its kind and will use the NIH's breadth of experience as a leader in biomedical sciences to help make the regulatory review process at the FDA as seamless as possible," he said.

The NIH and the FDA will hold a public meeting this spring to solicit input on how the agencies can work better together. More information about the partnership is available online (www.fda.gov/scienceresearch/specialtopics/regulatoryscience/).

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