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Success is Uncertain for FDA’s Regulatory Science Initiative

FDA Matters was an early advocate for regulatory science. It has been exciting to see the concept grow from the Commissioner’s first public speech to the President’s request for $25 million in FY 2011. And now, FDA has released a White Paper describing the Regulatory Science Initiative (RSI).

It is an excellent report and I applaud those who worked hard to create it. Still, I have misgivings about the way the White Paper characterizes regulatory science, leading to concerns about whether RSI will develop the necessary political and public support to be a long-term, permanent part of FDA.

According to the report:

“Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.” (emphasis added).

I would suggest that:

“Regulatory science is the tools, techniques and knowledge needed by food, medical product and other FDA regulators to carry out their public responsibilities.”

FDA’s definition makes regulatory science about what FDA develops (new tools, standards, etc.) and about regulated products. Instead, it should be about how regulatory science makes it possible for FDA to carry out its public health mission in an increasingly complex scientific and global environment. It needs to be clear 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. These are public purposes for which it is possible to gather broad support.

Most agency funds are spent to carry out applied regulatory science. A smaller, but not insignificant part of the agency budget is already being spent to create and improve regulatory science. For example, much of the budget of the Center for Food Safety and Nutrition that is not spent on inspections and enforcement is focused on better tools and knowledge to create a safer food supply. Most of the work of the National Center for Toxicological Research is devoted to improving regulatory science through the creation of science-based standards.

Regulatory science is not new and is much larger than an agency initiative. Rather, it is a re-conceptualization of who the agency is and what it does. Without this larger and more visionary framework, I fear that RSI is going to be underfunded by Congress and pushed aside when dollars are tight.

What reason is there to think so? The Critical Path Initiative (CPI) was launched with significant fanfare. The original report was one of the most lucid statements I have ever read from a government agency. The projects that Critical Path supported appear to have been well-conceived and responsive to broad, serious regulatory science needs within FDA.

Yet, the Critical Path completely failed to capture Congress’ imagination. It received very modest financial support from Congress, even in the last few years when the FDA’s budget expanded significantly.

RSI risks the same failure if Congress and other policymakers can neither explain “regulatory science” nor understand why it is fundamental to FDA’s mission success. As judged by CPI funding and the limited enthusiasm that it generated, Congress saw it as a nice add-on, but not a necessity.

If RSI can’t do better than this, it will not grow and prosper once the initial excitement fades. This would be a great shame because improving regulatory science is essential to making FDA into a 21st century regulatory agency.

That’s why it matters what FDA says now about the RSI. Undoubtedly, the agency wants regulatory science to be seen as a better, more holistic way to understand and improve the agency. At the moment, it still looks more like a collection of worthwhile agency improvements that have been bundled into a new initiative.


The FDA White Paper, Advancing Regulatory Science for Public Health, can be found here, along with the Commissioner’s speech on the topic at the National Press Club: http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/default.htm

One of several earlier FDA Matters‘ columns on regulatory science:

CARS: The Vehicle for FDA’s Future October 25th, 2009

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. Read the rest of this entry »

One Response to “Success is Uncertain for FDA’s Regulatory Science Initiative”

  1. gordida says:

    I have worked as a reviewer at the FDA CDER and now 15 years in industry in regulatory affairs in drug development. This unique vantage point allows me an understanding what it is like in the “inside” vs the “outside”. For the most, the main difference is that my former colleagues are looking for perfection i.e. a safe drug that is effective while my colleagues on the industry side are more than ever are looking to speed things up, take risk, and cut costs. The FDA is going one way while industry is going the opposite direction.

    In approving a drug, the bottom line is there are no short cuts since there is a human behind the review who is influenced by the environment we live in of a society that demands safe drugs. In reviewing a drug, the review of its efficacy is straightforward because that is for the most part one point that is quantifiable and its level of significance is measurable with a p value. The crux of a review is the review of safety which is understandably broad, not one point, and ultimately boils down to risk:benefit assessment which is viewed through many filters.

    The FDA and industry say the word of benefit:risk assessment but really, in my humble opinion, do a poor job of implementing it. Thus, the primary focus the Regulatory Science Initiative should be standardizing the assessment of benefit:risk. This would take a great deal of guess work and misunderstandings between FDA and industry if everyone is operating from a common understanding.

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