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CARS: The Vehicle for FDA’s Future

Since Labor Day, Commissioner Hamburg has spoken a number of times about the importance of regulatory science. She is right. FDA must have the scientific tools and methodologies to be a 21st century regulatory agency. FDA needs to define regulatory science, develop programs to support it, and package them in a way that will quickly bring recognition and funding.

This is a large task for Commissioner Hamburg to take on while running FDA and overseeing products that account for one-quarter of consumer spending. Yet, the agency will never improve if she doesn’t find the time. Given increasing globalization, ever more complex science, and new Congressional mandates, the agency may even lose ground without important advances in regulatory sciences.

FDA is already involved in creating scientific tools and methodologies to support good decisions. The Critical Path Initiative (CPI) has been an important first step in creating a list of worthwhile projects to advance regulatory science. Many have been funded.

The National Center for Toxicological Research, a backwater of sorts at FDA, has been quietly supporting the scientific needs of the rest of FDA by developing new scientific tools, methodologies, and knowledge. Subtract field activities from the budget of the Center for Food Safety and Nutrition (CFSAN) and a large part of the Center’s remaining budget is devoted to advancing regulatory science (e.g. creating faster assays to test for bacterial contamination).

The Center for Drug Evaluation and Research (CDER) also plays a role. Developing biomarkers is part of advancing regulatory science, as are new tools for surveillance and bioinformatics. The value is realized when these become part of tomorrow’s regulatory decisions.

CPI was once considered the way to pull all of these activities together to advance regulatory science at FDA. It has not developed the vision or support necessary to accomplish this. Efforts to develop public-private funding for CPI activities have also been a distraction. We now know that Congress needs to fund these activities so the regulators lead regulatory science, not the regulated.

Several months ago, FDA Matters proposed the creation of the Center for the Advancement of Regulatory Sciences (CARS) at FDA. The Center was to be a defining enterprise—consolidating existing activities within FDA, providing a separate basis for advocacy and funding, and making clear that advances in regulatory science serve the future needs of the FDA Centers. I believe the CARS concept can be a starting point for discussing how advancement of regulatory science can become integrated into FDA’s mission.

By talking about advancing regulatory science, Commissioner Hamburg is onto something important. We need to support her and help her develop broad acceptance of regulatory science among the policymakers who authorize programs and appropriate monies for FDA.


A definition of “regulatory science” and additional discussion are contained in my earlier columns:

Save the Critical Path—Part 1, June 17th, 2009

The American public and the global marketplace wish to have access to innovation—whether in medical products or foods. Simultaneously, there are strong countervailing concerns about product safety. Both occur within an environment in which FDA’s knowledge and tools are inadequate and failing.

The Critical Path program and related initiatives in CFSAN and other centers are designed to meet this challenge. Unfortunately, there has never been a sustained agency-wide commitment to these efforts. Further, most of Congress has not embraced the Critical Path, either conceptually or with substantial funding. Read the rest of this entry »

Save the Critical Path—Part 2, June 28th, 2009

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. Read the rest of this entry »

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