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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.

2 Responses to “Save the Critical Path—Part 2”

  1. coco says:

    I would define “Regulatory Science” as a marriage between science and the laws, so called the FDA laws.

    Thus, the term “regulatory science” refers to any scientific activity or products designed, developed or produced through the state of art methods or tools that can be interpreted within the meaning and scope of the FDA laws.

  2. anorris says:

    I agree strongly with the rationale for the Center for the Advancement of Regulatory Sciences (CARS). However, it is interesting that so few people seem to understand the work and capabilities of FDA’s National Center for Toxicological Research (NCTR) in Arkansas. NCTR has been working since its inception in the early 70’s to do what it could (with inadequate resources like the rest of FDA) to accomplish much of what you have described as goals for CARS. Granted, the CARS concept (at least as I understand it) would extend the current programs of NCTR to more proactive interaction with industry along with the mechanisms to accomplish that interaction, but much more than a foundation for CARS already exists. To duplicate what NCTR has created would be enormously wasteful.
    In review, some two years ago, NCTR was reorganized out of “Center” status. It was the only FDA center without a specific regulatory mission; thus able to conduct crosscutting research. That status enabled NCTR to interact with other agencies, academia and industry in a way that minimized the appearance and risk of conflicts of interest. The NCTR interest has historically been one of outreach and collaboration.
    After the original FDA Science Board report where its members were unsure what to do with NCTR, they found in a subsequent in-depth review that NCTR is a well-run, highly effective contributor. Moreover, many of the problems found by the Science Board across FDA were not true of NCTR. Morale is high, turnover is practically non-existent, peer review is multi-leveled and superb, scientific output is high, publications are in high quality journals and plentiful. The Science Board Subcommittee also found excellence in many of the areas of emerging science critical to future regulatory activities. That subsequent review found that distance from the D.C. area was not (or should not be) an issue. Also, according to the minutes of a Science Board meeting in May 2008, Dr. Cassell argued strongly for consideration of NCTR as the site for work similar to the goals stated for CARS. NCTR’s non-alignment with a regulatory responsibility, its history of collaborative relationships with others agencies, academia and industry, combined with its excellence in pioneering work with emerging technological applications put it in a position to save a huge amount of start-up effort.
    At a time when FDA is working to assure independent scientific bases for its work, it would seem that moving NCTR back out of the Office of the Commissioner to independent CARS status would be a giant step in the right direction. Having made that claim, I believe it is also important to re-think the relationship between NCTR, the center directors, and the other scientists. I agree that the center directors must indeed be the clients whose needs are addressed and who have say in seeing that they are addressed. It seems that a management structure consisting of the center directors and others could be structured to assure that the needs of each center are being met, that there would be effective measures to assure accountability for both scientific direction and results, and that the work is coordinated with the science in the other centers. With relatively little effort, it would also be possible to have center scientists participate in the research efforts through virtual and actual interaction at any level desired. Its existence in Arkansas should not be a reason for failure to build on this strong, developed scientific capability. Charging NCTR with the CARS responsibility would be a step in efficiently utilizing existing resources.

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