Stephen Hahn as the next FDA commissioner: What to expect from the agency in 2020

BY: GREG DOMBAL
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Stephen Hahn as the next FDA commissioner: What to expect from the agency in 2020

By Greg Dombal, President & COO

Dr. Stephen Hahn of MD Anderson Cancer Center was confirmed as the next FDA Commissioner this week by a 72-18 vote in the Senate. Dr. Hahn will be thrown immediately into several massive public health issues. Dr. Hahn noted in his confirmation hearings that he makes decisions based on data, science and the law and that he has depended on the FDA for the entirety of his career to provide him with confidence in the treatments he’s prescribed. The support he has received comes from a broad range of FDA stakeholders who are supportive of his medical prowess and acumen in making decisions based on the data.

He will inherit an agency that seems to have a rapidly growing list of major public health issues to deal with. The current crises – lung disease and injury associated with vaping, e-smoking and generic drug contamination concerns – are headline-generating but not the only issues facing the agency. The FDA faces questions from Congress and consumers on the regulatory framework and their actions (or lack of) with Purdue that may have contributed to the easy access to opioids. That history continues to be part of the story as we grapple with the ongoing opioid epidemic.

On a product level, there are massive issues of product safety and efficacy that will be thrust on Dr. Hahn and the FDA. What is the real utility of real-world evidence (RWE) for supporting product approvals? Our industry has invested heavily in tools, methods, and studies to collect real-world evidence and our understanding of many products is vastly improved because of this effort. However, a study using RWE is rarely as prospective or controlled as the traditional adequate, well-controlled trials that most products are approved upon. On a more tactical level, Dr. Hahn’s commitment to data and science will be tested right away as Biogen seeks approval of aducanumab on the strength of a limited subset analysis of data from their unsuccessful Phase 3 program. There very well might be data that shows disease modification in certain patients with Alzheimer’s Disease, so perhaps the science is telling us one thing while the overall data tells a different story.

The scientific, medical and compliance professionals at the FDA have always risen to the challenges of protecting public health, although it seems decisive leadership is necessary given the breadth of urgent issues the agency must weigh in on. Surely the learning curve of running a massive government agency will be steep for Dr. Hahn, however, it seems that he will have no choice but to dive right in—it’s sure to be an exciting ride!