With President Trump’s nomination of Dr. Heidi Overton as FDA Commissioner and the pending confirmation hearing, it’s worth asking for clarification about what qualifications are required to meet the weighty responsibilities of the position. Are there any positions, policies, or approaches to the job that are disqualifying?  In the initial wave of reaction to Dr. Overton’s nomination, it became clear that many people have lots of questions and concerns. A likely flashpoint is her stance…

A Larger Context for Readers Monitoring FDA’s Review of Unapproved Peptide Drugs For more than a century, FDA has been working towards ensuring that drugs are consistently manufactured at scale to FDA standards. As a result, consumers can be largely assured of drugs that are safe, effective, and identical to the FDA-approved original, generic, or biosimilar product.   My most recent column on the topic (here) compared the situation to a large jigsaw puzzle with a few pieces missing, yet the…

Initial FDA approval gets all the glory in the world of drugs and biologics. However, that approval has limited value if patients cannot rely upon receiving the original FDA-approved drug product (or an FDA-approved generic or biosimilar).  For over one hundred years, the U.S. Food and Drug Administration (FDA) has followed the precept that unsafe medicines are most often the result of improper and inconsistent manufacturing and inadequate quality control. The modern framework—spanning…

Around DC, there are a lot of smart people talking about the race to fill the job of FDA Commissioner. To me, it’s more of a slog than a race; certainly, more of a marathon than a sprint. It’s highly unlikely that anyone will be nominated soon, and no one will be confirmed quickly.  In my column on May 15, 2026, column (here), I observed that:   Dr. Makary’s departure doesn’t change the fundamental difficulties of being FDA Commissioner under President Trump and HHS Secretary Kennedy. His…

Drew Armstrong at Endpoints News brilliantly titled his summary of the Makary era: “An Impossible Job, Done Badly.” (here)  I could not agree more.  Unfortunately, nothing about the “impossible job” of FDA leadership has been made any easier or better by Dr. Makary’s departure. The hot, divisive, ongoing issues (e.g., vaccine policy, tobacco, drug approval standards, and mifepristone) have not suddenly disappeared. In addition, by compelling Dr. Makary to authorize flavored vaping, President…

Dear FDA Matters readers: FDA Matters’ newest feature puts a spotlight on causes and organizations that affect FDA and the FDA stakeholder community. Two prior Spotlight columns are here and here. More will follow. If you are aware of a cause or an organization that could benefit from a spotlight column, please reach out to me. Thanks. Steven —————– Last Fall, I wrote an FDA Matters column titled “FDA is the Department of Homeland Security for Food and…

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…