The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) announced plans to team up in order to accelerate the process from scientific

breakthrough to the availability of new, innovative medical therapies

for patients Wednesday.

Speakers at the event included U.S. Health & Human Services Secretary Kathleen Sebelius, NIH Director Francis S. Collins, M.D., Ph.D., and Margaret A. Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration.

The initiative will involve a forged partnership between two historically separate sciences:  translational sciences and regulatory sciences.  Translational science is the shaping of basic scientific discoveries into treatments.  Regulatory science develops and uses new tools, standards, and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy, and quality.

“We’ve all been following the remarkable advances in biomedical

sciences led by the NIH with great enthusiasm for years,” said Secretary Sebelius. “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 towards fostering access to the

safest and most effective therapies for the American people.”

In order to spearhead the effort, the agencies will establish a Joint NIH-FDA Leadership Council that will work together to identify important public health issues.  The Council will work to ensure that biomedical research planning and regulatory considerations work in congruence by integrating the latest sciences into the regulatory review process.

FDA and NIH will issue a joint Request for Applications, which will make $6.75 million over three years available for the initiative. 

This partnership should bolster the current scientific knowledge base by providing new research methods, models, or

technologies that will inform the scientific and regulatory community

about better approaches to evaluating safety and efficacy in medical

product development.

The FDA and NIH will hold a spring meeting for the public to solicit input on how the agencies can work together better.  “We’re in favor of openness here at NIH…hearing from advocates and stakeholders is important,” said Collins.

“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 Hamburg. “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.”

The FDA has over 100 years of experience and knowledge in the regulatory field for drug approval, biologics and medical devices.  NIH brings a vast amount of experience in research and development for new discoveries in the laboratory and clinical arenas. Collaboration between the two should produce discoveries and products that benefit people.  

“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,” said Collins.  “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 official NIH/FDA press release regarding the announcement is available on the FDA website.