This week’s FDA Matters column is entitled: “RFK Jr.’s Anti-Vaccine Stance Infiltrated FDA. Trump Is Reining It In.” It was published in MedPage Today at https://www.medpagetoday.com/opinion/second-opinions/120041?trw=no. They subtitled the article: “Here’s what the Moderna flu shot debacle was really about” Here is a paragraph from article. I encourage you to read the column in its entirety: The handling of the Moderna flu shot application was in no way consistent with the way FDA…

This week, we cover: FDA’s new “one pivotal trial” policy NIH Director, Dr. Bhattacharya’s appointment to be acting Director of CDC An activist HHS Secretary is a new thing. FDA’s New “One Pivotal Trial” Policy For many years, FDA’s policy has been “two studies are needed for approval of a new drug, but we will listen to any reasonable argument that one is sufficient.” Commissioner Marty Makary and CBER Director Vinay Prasad are changing this to: “only one study is required unless we tell you…

A cornerstone of my predictions for 2026 (here) was that: anything that touches upon public health (especially vaccines) or diet and nutrition was likely to have a particularly difficult and unpredictable year, and food and medical product safety programs and product reviews that do not involve public health or diet and nutrition, will be largely unchanged and largely predictable, albeit conducted with less staff, with longer and more frequent delays, and with a lot of frustration at FDA and…

FDA Matters doesn’t cover the news….we provide analysis of what’s behind the news. This week, we cover: drug ads at the Super Bowl and whether FDA will intervene against mass compounding of FDA-approved medicines; how prediction markets may affect FDA; and how AI can be used to cut months off the validation of new biopharma manufacturing facilities.   Super Bowl: Who Will Win the Pharma Ad Wars? Will Hims & Hers Be Flagged by FDA for Unsportsmanlike Conduct? On Sunday, February 8, at…

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 way…or at least provide a significant speed bump to slow things down. The Trump “secret sauce” is to “flood the zone” with actions and proposals that combine the Administration’s obsession with norm-breaking (often for its own sake)…

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),…