Building a Truely 21st Century Regulatory Agency

Listening to FDA speakers and talking with patient groups and companies at a 2-day conference last week, I gained a new appreciation of the vast improvements in how well FDA serves the American public and the agency’s stakeholders. My main observation in last week’s column: there was nothing wrong with “your father’s FDA,” but the agency has done a lot of growing since then.The column reflected input from stakeholders who were “impressed by the agency’s commitment to science-based decision making and its enthusiastic embrace of medical progress. Every FDA speaker [at the conference] touched on at least one of these themes: collaboration, urgency, transparency, inclusion, and adaptability.” Because the Alliance is such a broad-based coalition, it can be hard to generalize ... but I think we can all agree that these are virtues. I might add: these are virtues that are not commonly associated with government agencies.What does it take to turn these five characteristics into action, so that they are not just platitudes? Good intentions and a strong sense of purpose are critical, as is a commitment to customer service. In FDA’s case, the American people are its customers, although the whole world relies on its good judgments.I would go further: if you want collaboration, urgency, transparency, inclusion, and adaptability, then you have to have the budget and well-educated manpower to do more than review documents and make narrow decisions. It takes time and resources to make a necessary process into a virtuous one.I have previously mentioned my work earlier this year with a pre-IND company whose future success (and ability to benefit patients) was dependent on FDA feedback. Resources being finite, FDA can only do so many meetings. Instead, we were offered the opportunity to submit questions and a briefing book. Remarkably, FDA met its tight 30-day cycle for responding and gave us the thoughtful feedback we needed.

This example (and there are many others) illustrates a more general point: organizations that are undermanned and overwhelmed are forced into short-term thinking. Instead of a virtuous process that advances the common good, too often shorthanded organizations have to think in terms of “What decision best preserves our limited resources?” Almost inevitably, that results in a resounding “No.” With more resources comes the opportunity to be more thoughtful, collaborative, transparent, inclusive, and adaptive, without sacrificing urgency. The final answer may be Yes/No/Maybe/Resubmit, but regardless, it will produce decisions that represent progress.The Alliance’s arguments for more FDA resources hinge on the agency’s ever-growing mission, the increased scientific complexity of the situations and issues it faces, and the challenges of globalized marketplaces in FDA-regulated industries. These are strong points and have resonated with policymakers. To these, we need to tell the story of how more resources result in better decisions, which, in turn, are the foundation of the 21st Century regulatory agency that we all want.

Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.