Pharmaceutical Online

Scott Gottlieb was unusually effective as a commissioner, and future commissioners would do well to learn from his playbook, Catalyst President Nancy Bradish Myers writes in a guest column published in Pharmaceutical Online.

Ms. Myers explores the unique skills Gottlieb brought to the position. For example, in addition to being a master communicator, his ability to operate in Washington, D.C. and leverage unconventional connections enabled FDA to gain support for new initiatives and clear hurdles to get things done quickly, she says.

However, she notes that according to those inside the FDA, his true “special sauce” was his ability to master issues quickly, “get it,” and approve recommendations for what needed to be done — and then, most importantly, offer effective support to make changes. He also encouraged center directors to be creative and use new twists to solve old problems.

Looking at the potential impact of his departure on the agency, Ms. Myers notes that once the direction of such a large agency is set, change will is likely to occur gradually. But among the first changes that may be likely is a slowdown in the frequency and boldness of announcements from the commissioner’s office. The future of some of the issues he has taken political risks in advancing, such as the crisis of teen use of vaping/JUULing products, will depend largely on who is nominated and eventually confirmed as his successor.

Ms. Myers notes that the biggest surprise is how sad thought-leaders within the agency will be to say goodbye. Overall, Gottlieb will be seen a strong Commissioner. The bar has been raised.