How The FDA Remade Drug Development

My new article in Asterisk Magazine

I have a new piece out in Asterisk Magazine: “Reputation (FDA’s Version)”

It’s a review of Daniel Carpenter’s epic 2009 history of FDA pharmaceutical regulation, “Reputation and Power”. I walk through the history of the FDA as told through Carpenter’s book and reflect on my own experiences at the agency, which I joined right around the time the book was published.

Cover of Reputation and Power by Daniel Carpenter (Princeton University Press, 2010)

In the piece, I trace the FDA’s history as it evolved from a small office charged with policing misbranded drugs to its current role as a globe-spanning gatekeeper and regulator of the entire pharmaceutical industry. Carpenter’s central insight - which resonated with me the most - is the FDA’s conceptual power: its ability to shape our basic understanding of pharmaceutical development and what it means for a drug to be “safe and effective”. Over decades, FDA shaped the template for how drugs are developed: from pre-clinical development through a series of “phased” clinical trials, culminating in FDA review and approval. The book - and my review - walk through how that happened.

If that sounds interesting to you, do read the whole thing. You’ll learn much more about FDA’s conceptual power, how it evolved, and how a relatively small agency came to obtain so much power in the first place. It’s a great read for anyone who’s interested in FDA, drug regulation, or how regulators shape the industries they regulate.

I’m grateful to the Asterisk team - and Clara and Jake in particular - for their thoughtful review and edits.