The FDA's new framework for "Advancing Regulatory Science for Public Health" has it's heart in the right place.
It even discusses the need for collaboration:
Support for mission-critical applied research, both at FDA and collaboratively
Support within the FDA is critical to expanding the field of regulatory science. An active research program, directly connected to the FDA review process, will not only bring needed advances in regulatory science straight to FDA review, product development, and evaluation but will also add value to guidance and policy development.
In addition, the discipline of regulatory science must be developed though support from both partnerships and external research and collaboration. There are substantial opportunities to enhance and expand current FDA programs and to develop new ones that support effective, more robust, external and collaborative efforts to advance regulatory science. Some projects are already under way:
• A Joint Leadership Council recently created by FDA and NIH to promote the expansion of regulatory science through enhanced scientific collaboration and jointly supported and administered extramural research grants in regulatory science.
• Creation and support of academic Centers of Excellence in Regulatory Science to carry out applied regulatory science research both independently and in collaboration with the FDA and as a locus for scientific exchange and training opportunities for both FDA and academic scientists
• Enhanced strategic collaboration and coordination with other governmental agencies to develop new programs to advance regulatory science and innovation
• Enhanced support and focus for the Critical Path Initiative to catalyze and enable partnerships and consortia that advance regulatory science and public health through innovation and modernization of the medical product development and evaluation process
• Partnership with the Reagan-Udall Foundation on projects in support of regulatory science
Good words. But two important words are missing ... "with industry."
Obviously, the one-line reference to the Reagan/Udall Foundation means "with industry" and it's possible that these words which must not be spoken also reside within "partnerships and consortia." But why the strange silence about such a valuable partner? Advancing regulatory science without regular and robust collaboration from the regulated? Not likely.
Fortunately, Peggy Hamburg often speaks about working with industry on Critical Path issues. Enquiring minds want to know if any references to "industry" were blue-penciled out prior to publication -- and if so, by whom.
The white paper intelligently comments that:
There is no single discovery — no magic bullet — to address our unique set of modern scientific regulatory challenges. But one thing is clear: if we are to solve the most pressing public health problems we face today, we need new approaches, new collaborations and new ways to take advantage
of 21st century technologies. And we need them now.
All said, this paper is a step in the right direction and people who work in (expletive deleted) should read it.
It even discusses the need for collaboration:
Support for mission-critical applied research, both at FDA and collaboratively
Support within the FDA is critical to expanding the field of regulatory science. An active research program, directly connected to the FDA review process, will not only bring needed advances in regulatory science straight to FDA review, product development, and evaluation but will also add value to guidance and policy development.
In addition, the discipline of regulatory science must be developed though support from both partnerships and external research and collaboration. There are substantial opportunities to enhance and expand current FDA programs and to develop new ones that support effective, more robust, external and collaborative efforts to advance regulatory science. Some projects are already under way:
• A Joint Leadership Council recently created by FDA and NIH to promote the expansion of regulatory science through enhanced scientific collaboration and jointly supported and administered extramural research grants in regulatory science.
• Creation and support of academic Centers of Excellence in Regulatory Science to carry out applied regulatory science research both independently and in collaboration with the FDA and as a locus for scientific exchange and training opportunities for both FDA and academic scientists
• Enhanced strategic collaboration and coordination with other governmental agencies to develop new programs to advance regulatory science and innovation
• Enhanced support and focus for the Critical Path Initiative to catalyze and enable partnerships and consortia that advance regulatory science and public health through innovation and modernization of the medical product development and evaluation process
• Partnership with the Reagan-Udall Foundation on projects in support of regulatory science
Good words. But two important words are missing ... "with industry."
Obviously, the one-line reference to the Reagan/Udall Foundation means "with industry" and it's possible that these words which must not be spoken also reside within "partnerships and consortia." But why the strange silence about such a valuable partner? Advancing regulatory science without regular and robust collaboration from the regulated? Not likely.
Fortunately, Peggy Hamburg often speaks about working with industry on Critical Path issues. Enquiring minds want to know if any references to "industry" were blue-penciled out prior to publication -- and if so, by whom.
The white paper intelligently comments that:
There is no single discovery — no magic bullet — to address our unique set of modern scientific regulatory challenges. But one thing is clear: if we are to solve the most pressing public health problems we face today, we need new approaches, new collaborations and new ways to take advantage
of 21st century technologies. And we need them now.
All said, this paper is a step in the right direction and people who work in (expletive deleted) should read it.
