In the early morning hours of January 13, STAT broke the story of Dr. Pazdur’s remarks at the JP Morgan conference in San Francisco. Read the entire story here. The full video is here. Pazdur speaks, people listen. And they should. The headline gives you the gist: “Pazdur warns that politics, ‘chaos’ are damaging FDA.” My latest column (below) was sitting on an editor’s desk. It anticipates what Dr. Pazdur said….and it provides a broader context for the concerns every FDA stakeholder…

We need government food policies that are understandable, sensible, feasible, flexible, actionable, and beneficial. Against that standard, the new 2026-2030 Dietary Guidelines for Americans (DGAs), released January 7, 2026 (here),  are not particularly useful. Many of the findings are unclear and probably not actionable, the message is garbled, and the inverted food pyramid is inexplicable. Worst of all, the DGA’s are not responsive to the most important realities of hunger in America….

A year ago, I launched FDA Matters (www.fdamatters.com) to help the FDA stakeholder community better understand the FDA. My analysis and commentaries have focused on the policy, organizational, and political challenges faced by the agency. Here are some highlights from my 2025 columns that seem particularly pertinent as we begin a new year. FDA’s Credibility Is Tied to Its Reputation for Science-Based Decisionmaking “Science is a discipline. As such, it has rules that must be followed for…

This week’s FDA Matters column, entitled “The Midterms Are Coming. Vaccines May Play a Role” is coauthored with Dr. Michael Miller and can be found here. It is a “call to action” to ensure that candidates understand that opposition to vaccines is harmful to their community. In the winter months ahead, we expect ongoing outbreaks of vaccine-preventable diseases. That is likely to stimulate public and media attention to the preventable morbidity and mortality associated with measles, whooping…

One of FDA Matters’ recurring themes is the importance of FDA inspections and enforcement activities (here, here, and here).   Product approvals get most of the public attention, but the agency would quickly fail without a robust, committed inspection staff. They need more resources–now and in the future–to maintain their vigilance. For those interested or affected by inspections, I highly recommend reading former FDA Associate Commissioner Michael Rogers’ article (here),…

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…

FDA Matters subscribers often start their week with my Q&A Monday column. To join them, you can subscribe (free) at www.fdamatters.com. A substantial amount of new information surfaced during the often quiet Thanksgiving week, so I wanted to share an edited and updated version of yesterday’s (December 1) Q&A column. This column addresses four issues: Commissioner Makary’s standing with the White House and HHS and what would likely happen if he quit or was pushed out, food policy…

This week, many of us will be sitting down to a Thanksgiving dinner and talking about the parts of our lives for which we are grateful. Consider adding thanks to FDA and its more than 15,000 diligent and dedicated staff. And a special thanks to the inspectors and compliance staff who never get sufficient credit for their difficult, invisible, and potentially dangerous work overseeing nearly 300,000 FDA-regulated facilities, including farms, food and medical ingredient processing plants, and…