Over the last two years, few FDA topics have consumed more sustained attention than the mass compounding of commercially available drugs.  GLP-1 (glucagon-like peptide-1 receptor agonists) drugs have been the focus of most of the public discussion. However, our concerns about mass compounding are categorical rather than specific to GLP-1s. They are also reinforced by a recent FDA statement (here) that reflects the agency’s mounting concerns on this topic.   Here is why:  Not All Types of…

Dear FDA Matters readers: This column is the second in a new series that puts a spotlight on causes and organizations that affect FDA and the FDA stakeholder community. The first (here) was on the Advanced Research Projects Agency-Health (ARPA-H). Another spotlight column is in process, and more will follow.  If you are aware of a cause or an organization that you feel could benefit from a spotlight column, please reach out to me. Thanks,Steven Early in my career, the leading animal rights…

FDA Commissioner Makary has embraced the cause of faster review times for drugs and biologics, an area that holds great promise for bringing innovative drugs to patients more quickly.1 While laudable and likely to succeed, faster drug review times are just one way to address the broader and more important question: “What can the FDA do to help innovative medicines reach patients faster?”   This column looks at ways to lower regulatory risks, improve the agency’s interactions with industry and…

Dear FDA Matters readers: This column is the first in a new series that puts a spotlight on causes and organizations that affect FDA and the FDA stakeholder community. I have a second spotlight column in process and am open to recommendations for future topics. Steven ———– ARPA-H is a relatively new federal agency within HHS, intended to support breakthrough biomedical research, particularly for projects that are not a good fit for traditional public and private…

There are so many interlocking and competing interests in food that it is hard to reach agreement on goals, let alone a plan for a future food system that is more coherent, effective, and better suited to each of our individual needs, desires, and situations. Nonetheless, what America needs is a US food supply that 1/ maximizes health, safety, affordability, and accessibility, and 2/ leaves everyone at least moderately satisfied that we have improved the food supply and their lives in…

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)…