The US National Institutes of Health and the Food and Drug Administration announced a new partnership to “accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients”.
While NIH sponsors basic and applied research, FDA is charged with ensuring the safety and effectiveness of products. The two agencies have always worked side by side, but a stronger collaboration is needed to speed the progress “from microscope to market,” said Kathleen Sebelius, secretary of the Department of Health and Human Services, who unveiled the collaboration today in Bethesda, Maryland.
Translating biomedical research into new products involves regulatory science, the methods used to develop products and evaluate safety, efficacy and quality. “Regulatory scientists must have the knowledge and tools to help translate discovery, innovation, and promise into real world products for those who need them,” said FDA commissioner Margaret Hamburg.
As part of the interagency partnership, a Joint Leadership Council will be established “to help ensure that regulatory considerations form an integral component of biomedical research planning, and that the latest science is integrated into the regulatory review process”. Hamburg and NIH director Francis Collins will co-chair this council, which will include currently unspecified working groups.
The agency heads reached for similar metaphors to describe the new effort. Hamburg likened the situation to a rower on a river: with one powerful arm that is biomedical research and a weaker arm that is regulatory science. Without a better balance, she said, “we will sadly row in circles”. Collins added, “We want to give that arm a good set of weights.”
Those weights will come in the form of $6.75 million in grants over the next three years for work in regulatory science. According to Collins, NIH could “squeeze” more funds if there was an outpouring of grant applications. The two agencies released a Request for Application for “Advancing Regulatory Science through Novel Research and Science-Based Technologies” today.
Collins and Hamburg did not offer too many specific examples of the kinds of issues that the partnership will tackle. According to Collins, they have “no terribly defined agenda now”. But they added that public input will be solicited this spring. Hamburg said, “We have an open door if you want to beat on it.”