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NIH and FDA Aim to Retool Regulatory Science

The Department of Health and Human Services, the National Institutes of Health, and the Food and Drug Administration today announced a partnership aimed at speeding new medical treatments from “microscope to market,” as HHS Secretary Kathleen Sebelius put it. The program will help researchers conducting basic biomedical research understand the regulatory parameters for drugs and devices developed from their work. In compliment, it will also help FDA scientists understand the latest science behind emerging technologies before they arrive at the clinical trial stage.

The coordination is an important move that will ideally shape a faster approval process for certain life-saving treatments, while also ensuring that therapies are safe and effective when they reach the marketplace. Moreover, this sort of tighter coordination is necessary for integrating personalized medicine into the health care system, as Michael Rugnetta and Whitney Kramer explained in a report last year.

The collaboration consists of three components:

  • NIH and FDA will form a Joint Leadership Council, chaired by NIH Director Francis Collins and FDA Commissioner Margaret Hamburg. Six additional members drawn from senior leadership at each agency will complete the membership. The council will share information in order to promote “the translation of basic and clinical research findings into medical products and therapies,” according to the council charter.
  • The two agencies will make available $6.75 million over three years to fund projects that advance regulatory science—$2 million per year from NIH and $250,000 from FDA. The notice of the funding opportunity was issued today and is likely to support from two to four projects. Example projects mentioned in the announcement include: development of new methods for identifying adverse effects from drugs and devices; crafting new clinical trial designs, particularly for rare diseases that affect small populations; building new assessment tools for emerging fields, including RNAi therapy, nanomedicine, and personalized medicine.
  • NIH and FDA will hold a public meeting this spring to solicit additional input on how to improve regulatory science and translational research. Results from that event may point the way to further public outreach.

“The need for such collaboration has never been more pressing,” said Collins, acknowledging that in the past, NIH may not have always brought FDA into the research process early enough, as well as that FDA may have lacked sufficient scientific knowledge of certain emerging technologies.

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