For the second time in as many years, we have been going through the ritual of getting a new FDA Commissioner appointed. The last one – Dr. Robert M Califf served from February 2016 until January of this year. Dr. Scott Gottlieb was nominated by the current Administration in March to be the new head of FDA with hearings in April. Yesterday the Senate confirmed Dr. Gottlieb as the new FDA Commissioner by a vote of 57 to 42.
An inherent component of the deliberation process is a focus on how the nominee might influence the future direction of the agency itself. During Dr. Califf’s nomination process, there were concerns raised in the Senate about ties to the pharmaceutical industry, a concern that repeated itself this time around regarding Dr. Gottlieb’s experience as a consultant and board member for several companies. The focus of concern is, of course, what influence will such ties be on the conduct of an FDA commissioner and on policy itself?
FDA Commissioners can obviously set priorities and direction in ways that will influence policy for the agency. For example, Dr. David Kessler, who served under both Presidents George H.W. Bush and Bill Clinton, had a long tenure. One of his many contributions involved efforts related to the regulation of tobacco products. Dr. Margaret Hamburg who served under President Obama took over the helm of FDA during a time when the agency had been very battered by a series of events that included high profile drug recalls. Her background and experience as the Health Commissioner for the City of New York among other things positioned her well to see to administrative reforms that restored confidence in the agency.
While the influence of an individual person obvious impact, outside events – or the demands of the time – have a much greater influence on the policies and actions of FDA. The agency is not just a big ship to steer, it is a really, really giant ship. It does not turn on a dime. It regulates not only a huge breadth – food, drugs and cosmetics – but with a very big depth. In the case of medicines, for example, this means shaping the kinds of clinical trials needed, the specific endpoints to shoot for, an enormous mechanism for approval and oversight of manufacturing as well as marketing. Change does not come easy to such a big system of regulation – it is definitely a process, not an event.
When FDA does make dramatic change, external events are the most likely driver of that process. Prior to the HIV/AIDS epidemic, approval times for drugs ran many months longer than they do today. Policymakers responded and FDA instituted reforms that resulted in Fast Track and Accelerated Approval and today the options for enhanced approval are numerous. The emergence of biosimilar medicines and the more rapid assembly of a regulatory pathway for their approval and use in Europe again moved Congress into action to create legislation that would authorize new regulations. There are numerous examples.
There are many pressing issues in medicine right now. From pricing issues (FDA does not involve itself in pricing) to the faster approval of generics to promises by the Administration to reduce the regulatory burden involved in drug approval. There are new emergent and successful classes of drugs that involve immunotherapy, personalized medicine and the press for an enhanced pursuit to find answers in cancer. These issues as well as others will undoubtedly shape the agency. But when it comes to how the FDA does its work, it is the presence of pressing issues, and the actions that policy makers take (such as passage of the 21st Century Cures Act) which will have the most lasting impact on the direction of FDA as he faces the large array of external events that will drive change over the next several years.
Other candidates under consideration for FDA Commissioner included some who did not have medical degrees. The choice of Dr. Gottlieb, who holds a medical degree, is a cancer survivor and has experience as a former FDA deputy commissioner, likely signals an acknowledgement on the part of the Administration that the complex questions of the time need experience, understanding and pragmatism to help shape the agency response in meeting the demands of today’s environment for medicine. The fact that he is doctor, patient and experienced administrator in a single person are likely the more important traits that will influence his tenure at FDA.