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…

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…