Save the Critical Path—Part 2
Transforming FDA into a first-class, 21st-century regulatory agency will not be easy. It requires planning, commitment and a broad vision. Science-based decisionmaking is a central part of the transformation, but it doesn't just happen by itself. Regulatory science needs to provide the tools, standards and knowledge for FDA to handle an ever-more complex world of science and commerce.
To meet this challenge and provide a broad vision, FDA Matters has proposed the creation of the Center for the Advancement of Regulatory Sciences (CARS). It puts FDA's science and FDA's future at the heart of the agency, where the commitment can be constant and everyone won't be running off to meet the next crisis.
"Save the Critical Path-Part 1" appeared ten days ago: http://www.fdamatters.com/?p=317. Here are some questions I have been asked since then.
What is regulatory science?
There is no standard definition for "regulatory science," although the term is widely used and generally understood. It means the tools, techniques and knowledge needed by food and medical product regulators to carry out their public responsibilities.
Fundamental to the concept is that consumers, patients and regulated industries benefit when regulators have sophisticated, state-of-the art capabilities and use them transparently, so that no stakeholder has to guess about the agency's approach. "Regulatory science" extends to every aspect of the FDA's responsibilities, including manufacturing, product tracking, laboratory procedures, post-market standards, sentinel monitoring, etc.
What are the key characteristics of CARS?
The purpose of CARS is to build the science-based decisionmaking capacity at FDA by creating and validating new scientific knowledge, tests and standards. It should produce greater consistency and predictability in the agency's regulatory activities.
CARS must be FDA-driven and funded with public monies. It must be an FDA initiative with stakeholder input, not an agency-stakeholder partnership. These characteristics are essential to obtaining and retaining Congressional support. There can be no ambiguity: this is FDA's initiative and the program's direction is coming from within FDA.
Consumers and industry benefit from an FDA that is more sophisticated in its approach, more capable in its actions, and more confident that its decisions are scientifically-derived.
Why can't Critical Path and the Reagan-Udall Foundation achieve CARS' purposes?
In Europe it has. The EU's Innovative Medicines Initiative (IMI) is multi-hundred million dollar program designed to address the main causes of delay in pharmaceutical R&D and encourage more rapid discovery and development of better medicines. In Europe, it is acceptable that this is done through a public-private partnership and it contributes to the strengthening of EMEA and national drug regulatory agencies.
If this approach were viable in the US, the Critical Path would be more deeply funded by Congress and the Reagan-Udall Foundation would be ready to accept private funding on a par with the IMI.
Neither has happened. Despite the good intentions of their advocates, there is little evidence it will. A public-private partnership of this type, heavily dependent on private support, will always make the activities and the results suspect in the US. Maybe it shouldn't be that way, but it is the reality we face as friends of the FDA.
CARS is an attempt to redefine these efforts and make them into wholly public activities that can draw broader acceptance and achieve quicker results. The goals of the Critical Path and the Reagan-Udall Foundation are a stronger, more future-oriented FDA based on improved regulatory science. If we can keep it public and FDA-centric, then this becomes possible again.