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Save the Critical Path—Part 1

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.

Only a strong, well-resourced FDA will have the time and manpower to address the future and give sponsors and other stakeholders the guidance they need. This can only be accomplished with monies that are specifically set aside for advancing regulatory science. It must be a major function of FDA, organized and funded separately from the divisions with every-day product responsibilities. In short, FDA needs to have an organizational home to promote knowledge and create standards in the regulatory sciences.

FDA Matters proposes the creation of a new entity at FDA: the Center for the Advancement of Regulatory Sciences (CARS). It will work with all centers (food, vet med, biologics, devices, drugs) to meet their existing, ongoing and future needs for knowledge, tools and standards.

Functionally, CARS should operate with the center directors as the primary clients and with the goal of helping each Center achieve its mission. CARS must be FDA-driven with stakeholder input, not an agency-stakeholder partnership. This is essential to obtaining and retaining Congressional support

The new Center should be closely aligned (through grants, contracts and strategic partnerships) with knowledge and expertise in academic medicine and other government agencies. The benefit to FDA of creating such relationships was an important part of the FDA Science Board report (December 2007). The Science Board found that external collaborations were underdeveloped and were particularly crucial for FDA in dealing with emerging sciences and technologies.

An initial funding level of $200 million per year would emphasize the importance of advancing regulatory science. It is vitally important that these funds be appropriated; none of the funds should come from user fees. There should be no ambiguity: this is FDA’s initiative and the program’s direction is coming from within FDA. This amount is about 10% of FDA’s current appropriated budget and far more than the current investment in Critical Path and related initiatives.

There are a number of barriers—not least the bias toward current results, rather than future development. Yet, there are good reasons why Congress, FDA and all FDA stakeholders should support advancement in the regulatory sciences. Food and medical academia should also be supportive: CARS makes them into an FDA partner and stakeholder.

CARS is about the future of FDA. Let’s embrace that future and show why it is worth such a large investment.


Part 2 will appear next week and provide additional supporting arguments for CARS.

If you have questions about CARS that you would like answered in next week’s column, please send them to me or post them below as a comment.

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