NIH And FDA Team Up

The National Institutes of Health and the Food & Drug Administration have joined forces in an unprecedented effort to strengthen regulatory science and bring new drugs to market faster. The new collaboration, announced at a briefing on Feb. 24, will provide $6.75 million in grants over three years for research on how to assess the risks and benefits of new medical treatments.

As part of the effort, NIH and FDA have formed a joint leadership council, cochaired by NIH Director Francis S. Collins and FDA Commissioner Margaret A. Hamburg. The council will oversee work between the two agencies and identify new areas for collaboration. It will also ensure that scientists consider potential regulatory hurdles during the planning stages of biomedical research and that regulators integrate the latest breakthroughs in science into the regulatory review process.

Strengthening regulatory science, or “the development and use of scientific knowledge, tools, standards, and approaches necessary for the assessment of medical product safety, efficacy, quality, potency, and performance,” is a critical priority for FDA, Hamburg stressed at the briefing. She acknowledged that the amount of money being invested is small but noted that the proposed fiscal 2011 budget gives FDA $25 million for regulatory science, the first direct investment in regulatory science in history.

“We didn’t want to wait until 2011 to get started,” Collins said. When asked whether NIH plans to invest more in the initiative in the future, he said it will depend on the response to this new effort.

Stakeholders representing a wide range of medical associations were generally pleased with the announcement. Some groups commented at the briefing that they hope to see more input from FDA on NIH-sponsored clinical trials, particularly for those involving rare diseases and thus a small pool of available patients. Others hope the partnership will help train the next generation of scientists to be better prepared for the regulatory process.

NIH and FDA plan to hold a public meeting this spring to get input from all stakeholders on ways that the two agencies can work together more effectively.