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Here are some highlights from my 2025 FDA Matters columns that seem particularly pertinent as we begin a new year. More details on each topic are contained in the full column.

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 policy and regulatory decisions to be meaningful, actionable, and effective. Data may be subject to interpretation and conclusions can vary, but the fundamentals of scientific thinking are always applicable.”

Critical Loss of Manpower and Expertise Can Be Partially Offset By The Growing Role of AI in Regulatory Science

 “AI can help bridge some--certainly not all--of the gap created by the loss of expert staff at the FDA. However, this is speculative, not proven...and the progress to date is likely real but almost certainly oversold.”

Inspection and Compliance: Harder and More Important Than Stakeholders, Congress, and the Media Realize

“Probably the single most essential service of FDA is its inspections and compliance work….Going back to the late 1800’s (the “Gilded Age” and pre-FDA), we know what happens if you do not regulate food and drugs.”

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 cough, influenza, respiratory syncytial virus, and other contagious illnesses. Some communities will be hard-hit economically because of worker absences due to personal and family illness.

Ordinarily, public health concerns don't have the immediacy or salience to affect elections. However, the state-to-state spread of this year's record measles outbreaks offer irrefutable evidence that anti-vaccine policies are not just a geographically isolated concern or a mistake with far-off consequences.

We believe vaccine policies will have concrete health and economic consequences in the short term, sufficient to make them a potential election issue in the 2026 midterms.

To understand why, please read our column at here. Other recent FDA Matters columns can be found at: https://www.fdamatters.com.

One of FDA Matters’ recurring themes is the importance of FDA inspections and enforcement activities.  Today’s column (“Me, FDA, and Maybe the Mafia”) focuses on a personal story and is dedicated to the brave inspectors and investigators who never know what they will find or who they will be dealing with during an inspection or criminal enforcement.

The story reflects FDA’s history as a struggle of competing interests. Sometimes reasonable people disagree. At other times, it is obvious that indifference or greed are the driving forces.

After all of these years, I still can’t say for sure whether my story involved reasonable people or dark forces.

My first recollection of the artificial sweetener, saccharin (distributed under the brand name “Sweet‘N Low”) was a 1977 visit to the House health subcommittee’s staff office. It was overflowing with boxes that contained letters begging Congress to prevent FDA from removing saccharin from the marketplace.

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 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 priorities and the relative lack of urgency on hunger and food safety relative to other goals,

• Dr. Pazdur disagreements with the Commissioner and why it has resulted in today’s retirement announcement, and

• CDC’s implied support of a vaccine/autism connection and how anti-vaccine efforts have now spread to FDA.