Short Takes and Updates February 6, 2026
This week, we cover:
1. Drug ads at the Super Bowl and whether FDA will intervene against mass compounding of FDA-approved medicines
2. How prediction markets may affect FDA
3. How AI can be used to cut months off the validation of new biopharma manufacturing facilities.
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:
Flood the Zone, Year 2: Predictions for 2026
For most of us, 2025 was a revelation. Things that we thought impossible (for example, abolishing federal employee unions) proved remarkably easy to do by fiat. Little or no deference was granted to rules and procedures that we all imagined would stand in the…
What Dr. Pazdur Said….What I Heard: The Threat of “CDC-ification” Is Real
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:…
New Dietary Guidelines? Let’s Talk About Food Access and Affordability Instead
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….
The Past Is Prologue: Three Insights from 2025 That Will Impact 2026
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…
The Midterms Are Coming. Vaccines May Play a Role.
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…
“Me, FDA, and Maybe the Mafia”–A Tribute to the FDA Inspectors Who Keep Us Safe
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…