An article in RPM, Regulatory Science: A Biodefense Backlash? by Michael McCaughan tinyurl.com/2byhfxr suggests that the effort to remake product development around 21st century science is stalling or even on life support:
"Securing funding for "Regulatory Science" has been a top priority for Commissioner Margaret Hamburg, highlighted most recently during an October 6 luncheon address to the National Press Club, coinciding with a white paper outlining the agency’s vision for enhancing its science base.
The initiative may be the last hope for the agency to play a central role in encouraging drug development as a core part of its mission, after the underwhelming results from prior efforts like the Critical Path Initiative and the Reagan/Udall Foundation. For industry, "Regulatory Science" funding may be the only hope to secure a pool of resources for the agency to craft policy in areas like companion diagnostics, surrogate markers, etc. without another significant step-up in user fees."
The problem is what money that has been spent is being steered to academic institutions that are not collaborating with either other, with other industry consortium or things on the Critical Path opportunities list. Further, lip service is being paid to adoption of new tools and pathways even as the FDA puts out guidances that ignore or fail to encourage their use. The muddled 510k guidance discussion and recent FDA guidance on submission of Phase I safety data are examples of guilt by omission.
I find myself agreeing with Senator Tom Harkin who expressed concerned about the FDA's increasing set of duties and inability to establish common protocols to speed development of anti-infectives and vaccines within the bio-defense sphere:
Stressing that he was “just thinking out loud,” Harkin suggested that maybe “we need to take something out of FDA, something out of Defense, that would be put under BARDA, and let BARDA be the lead agency.” (Harkin previously noted the “hard work” he and others in Congress put into creating BARDA, and wondered how the new HHS initiative fit within that framework.)
Harkin noted his ongoing frustration with the failure to achieve licensure of cell-based flu vaccines. “FDA just—institutionally, I don’t know if they can do it,” he said. “It is just that they have so much to do and they have other responsibilities, and mostly they are focused on drugs that we take for illnesses.”
That's quite a statement. Unfortunately the organized interests in Washington are more interested in rent-seeking than getting things done.
Just thinking out loud...maybe everyone needs to redirect efforts towards the development of collaboration to produce the science and regulatory culture required to sustain advances in clinical development and the goal of increasingly effective use of products once on the market. That's what the Critical Path is and was about. Discussions about what can be done with fees collected under The Prescription Drug User Fee Act are starting.
www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm
That might be a good time and place to introduce changes in priority and purpose.
"Securing funding for "Regulatory Science" has been a top priority for Commissioner Margaret Hamburg, highlighted most recently during an October 6 luncheon address to the National Press Club, coinciding with a white paper outlining the agency’s vision for enhancing its science base.
The initiative may be the last hope for the agency to play a central role in encouraging drug development as a core part of its mission, after the underwhelming results from prior efforts like the Critical Path Initiative and the Reagan/Udall Foundation. For industry, "Regulatory Science" funding may be the only hope to secure a pool of resources for the agency to craft policy in areas like companion diagnostics, surrogate markers, etc. without another significant step-up in user fees."
The problem is what money that has been spent is being steered to academic institutions that are not collaborating with either other, with other industry consortium or things on the Critical Path opportunities list. Further, lip service is being paid to adoption of new tools and pathways even as the FDA puts out guidances that ignore or fail to encourage their use. The muddled 510k guidance discussion and recent FDA guidance on submission of Phase I safety data are examples of guilt by omission.
I find myself agreeing with Senator Tom Harkin who expressed concerned about the FDA's increasing set of duties and inability to establish common protocols to speed development of anti-infectives and vaccines within the bio-defense sphere:
Stressing that he was “just thinking out loud,” Harkin suggested that maybe “we need to take something out of FDA, something out of Defense, that would be put under BARDA, and let BARDA be the lead agency.” (Harkin previously noted the “hard work” he and others in Congress put into creating BARDA, and wondered how the new HHS initiative fit within that framework.)
Harkin noted his ongoing frustration with the failure to achieve licensure of cell-based flu vaccines. “FDA just—institutionally, I don’t know if they can do it,” he said. “It is just that they have so much to do and they have other responsibilities, and mostly they are focused on drugs that we take for illnesses.”
That's quite a statement. Unfortunately the organized interests in Washington are more interested in rent-seeking than getting things done.
Just thinking out loud...maybe everyone needs to redirect efforts towards the development of collaboration to produce the science and regulatory culture required to sustain advances in clinical development and the goal of increasingly effective use of products once on the market. That's what the Critical Path is and was about. Discussions about what can be done with fees collected under The Prescription Drug User Fee Act are starting.
www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm
That might be a good time and place to introduce changes in priority and purpose.
