Tomorrow is Election Day. If you haven’t already, please vote. With so many races predicted to be close, your vote matters more than ever. Over the last 20 months, the Trump Administration has proven hostile to policies and programs generally favored by the public health, medicine, bioscience, and scientific research (here) communities.  Unlike many past battles on similar issues, Congress has been largely ineffective in countering the onslaught of program cuts and adverse policies emanating…

In a new MedPage Today op-ed, Steven Grossman and Michael Miller, MD, look past the November midterms to what vaccine advocates should expect in 2027. Pro-vaccine coalitions made real gains this year, coordinating legal challenges to the reshaped ACIP and pushing back on state efforts to expand school vaccine exemptions. But a stronger pro-vaccine presence in Congress may not be enough: with HHS Secretary Kennedy expected to stay and revive previously blocked policies, and a White House that…

In a new MedPage Today op-ed, Steven Grossman explains why he supports Heidi Overton, MD, PhD, the administration’s nominee for FDA commissioner. At her Senate HELP Committee confirmation hearing, Overton kept to a clear principle: anything the FDA has deemed safe and effective stays that way until the agency reviews contrary evidence, and its decisions must follow the law. That led her to affirm the safety of FDA-approved vaccines, including MMR. Grossman acknowledges real gaps, including no…

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…