FDA Is Built on Predictability and Expertise, Not Norm-Breaking

by Steven Grossman | Dec 11, 2025

Permission is granted to reprint or recirculate this column, as long as attribution is made to FDA Matters and the author.

This week’s FDA Matters column, entitled “FDA is Built on Predictability and Expertise, Not Norm-Breaking,” can be found here.

My position has been “whatever you think of the specific policies and actions that Commissioner Makary is pursuing, and 2/ whatever you think of his leadership and management styles….we must speak our truth AND YET also make clear that we support his leadership of FDA.”

Unfortunately, the situation at FDA has deteriorated over the last few weeks. The downside risk has increased greatly. To understand why, please read my column here.

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FDA Matters analyzes FDA policy and regulatory issues and advocates for a more effective, efficient, and fair FDA.

FDA Matters doesn’t cover the news….we provide analysis of what’s behind the news.

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FDA Matters provides short-form analysis of FDA policy and regulatory issues. We know you are busy, so we publish 1 to 2 columns per week, each a 3-5 minute read.

FDA Matters does not report the news….we provide analysis of what’s behind the news.

FDA Matters advocates for a more effective, efficient, and fair FDA.

FDA Matters has been featured in:

Steven Grossman

Steven A. Grossman, JD, is the founder and author of FDA Matters. Read more about Steven here.

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