How A Rapid, Well-Messaged US FDA Offense Is Driving Spectators To Their Feet And Twitter Accounts

Consultant Nancy Bradish Myers examines why US FDA seems to be accomplishing so much under Commissioner Gottlieb’s leadership and how this could inform future leadership selections.

Commissioner Gottlieb speaking at RAPS 2017
What is the "secret sauce" to Commissioner Gottlieb's success?
About The Author

Nancy Bradish Myers, JD, president of Catalyst Healthcare Consulting, is a Washington, DC-based attorney with deep expertise in health-care law and regulation, policy development, and government relations. She served as senior policy counsel in the Office of the FDA Commissioner, as well as special assistant/senior strategic advisor to the FDA acting deputy commissioner for operations. She has been closely involved in drug, biotechnology and medtech regulatory issues for more than 25 years.

“How is FDA doing under Commissioner Scott Gottlieb?” is a question that, as a regulatory policy and strategy consultant, I am asked regularly. With amazing frequency, the questioner follows up with a twinkle in the eye and a statement that is similar to a rock-star groupie suggesting, “Isn’t he dreamy?”

So, let me tell you, most FDA watchers who long to hear from the agency early and often, and who...

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