Scott Gottlieb, a man who had the job he wanted more than any other, resigned at Commissioner of the Food and Drug Administration. The reason, reportedly, is the long commute between Washington, D.C. and his home in Connecticut.
It is a good excuse but still seems somehow odd. The Commissioner is in the midst of several major policy initiatives like expanded access to biosimilars, improved generic approval rates, modernization of medical device standards, among other things. Several drug policies like an end to rebates originated in work Gottlieb did at the American Enterprise Institute.
In the fullness of time, we will know what policy disagreement or other factors led to his departure. In the meantime, we are left to evaluate the impacts.
- First and foremost, the loss of a major agency head generally results in inertia. Significant policy initiatives are usually placed on hold until Congress confirms a successor. Strategic changes already institutionalized like improved generic access will continue to be implemented. However, new policy development will likely wait. Development of twin regulatory regimes - for dietary supplements and higher concentration drugs - for CBD products, for example, is probably going to wait until a new Commissioner is approved. Last month Gottlieb had indicated that a public meeting would be held in April. That event and all the internal decision making leading up to and following public input could be delayed.
- Initiatives that use the bully pulpit and the charisma of an agency leader may also suffer. Gottlieb has made smoking cessation a priority by emphasizing use of smokeless tobacco delivery systems. He has also vigorously addressed use of all tobacco products – combustible and smokeless – by minors, taking a particularly tough stance against JUUL.
- Unlikely to be affected is the Trump Administration’s policy on drug prices. Although many facets of the safe harbor rule represent Gottlieb’s policy view, Secretary Azar and CMS Administrator Verma, have and will continue to lead the charge.
What remains to be seen is who shall be nominated to replace Gottlieb and how that person’s views might differ from the Commissioners.
Call with questions.
Emily Evans
Managing Director – Health Policy
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