The NIH and FDA announced “a new collaboration on regulatory and translational science to … help speed the translation of research into medical products and therapies.”
Oh, you know this is going to be good, starting with their description of the two, um, partners in this collaboration:
The initiative involves two interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into treatments; and regulatory science, the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality. Both disciplines are needed to turn biomedical discoveries into products that benefit people.
And, indeed, the NIH is just the partner to make it happen, according to Francis Collins:
“This collaboration … 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.”
Hmm. Somehow I missed that improving the FDA’s regulatory review process was a major priority in biomedical research, though clearly the FDA does need help in that department. But wait, there’s more …
As part of the effort, the agencies will establish a Joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The Joint Leadership Council [chaired by NIH Director and FDA Commissioner plus 6 members from each agency] will work together 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.
I have not yet had time to view the entire hour-long videocast of this announcement, so I didn’t hear how much the NIH budget would be increased to absorb this additional effort (which will clearly need more than $6.75M to succeed).
However, this new emphasis on regulatory science does explain the latest unusual RFA issued from the Office of the Director (supported with $6M from the NIH Common Fund and $650K from the FDA), Advancing Regulatory Science through Novel Research and Science-Based Technologies (U01), which offers up to $675K in direct costs per year for 2010, 2011, and 2012. The RFA describes 5 broad areas of research to be supported … by 2-3 awards.
More big applied science, one hopes not at the expense of the most basic biomedical research needed to fill the translational pipeline with science to “shape into treatments.”