FDA and NIH Collaborate to Speed the Introduction of New Medicines

Last week, the US Food and Drug Administration and the National Institutes of Health (NIH) unveiled plans to establish a Joint Leadership Council to address important public-health issues. The goal of the initiative is to accelerate the process of translating a scientific breakthrough into the availability of new, innovative medical therapies for patients.

The initiative involves translational science (i.e., converting basic scientific discoveries into treatments) and regulatory science (i.e., creating and using new tools, standards, and approaches to develop products efficiently and to evaluate product safety, efficacy, and quality effectively). The Joint Leadership Council will seek 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.

As part of their collaboration, NIH and FDA will jointly issue a request for applications and make $6.75 million dollars available over three years to fund work in regulatory science. The agencies intend for the research supported through this initiative to increase the scientific knowledge base by providing new methods, models, or technologies that will inform the scientific and regulatory communities about better approaches to evaluating safety and efficacy in medical-product development.

“We’ve all been following the remarkable advances in biomedical sciences led by the NIH with great enthusiasm for years,” said Kathleen Sebelius, secretary of the US Department of Health and Human Services, in an FDA press release. “However, much more can be done to speed the progress from new scientific discoveries to treatments for patients. 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.”

“The FDA plays an essential and unique role in how therapies are evaluated. We are the bridge between biomedical research discoveries and new medical products,” said FDA Commissioner Margaret A. Hamburg in the press release. “We now have a special opportunity-and responsibility-to harness advances in science and technology to support our efforts. We are working in collaboration with the best minds and research institutions available so that we can better develop and utilize new tools, standards, and approaches needed to properly assess the safety, effectiveness, and quality of products currently in development or already on the market.”

NIH Director Francis S. Collins, in the press release, said, “For more than two decades, the NIH and the FDA have been partners in multiple health initiatives designed to improve the health of millions of Americans. This collaboration, however, 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.”

The effort will rely on NIH’s experience supporting and facilitating discoveries in the laboratory and clinic and FDA’s experience and knowledge in regulating and approving drugs, biologics, and medical devices. The organizations will hold a public meeting in the spring to solicit comments about how they can work together better.