Can the Midterms Save Vaccines? Don’t Count on It.
n 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.
FDA Matters provides short-form analysis of FDA policy and regulatory issues. We know you are busy, so we publish 1 to 2 columns per week, each a 3-5 minute read.
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Leading FDA Is an Impossible Job Right Now. Heidi Overton Could Still Do It Well.
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…
Chairman Cassidy: Please Ask Dr. Overton About FDA Decision-Making
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…
The FDA’s Century-Long Campaign to Assure Safe Manufacturing (Part 2)
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…
The FDA’s Century-Long Campaign to Assure Safe Drug Manufacturing (Part 1)
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,…
A Marathon, Not a Sprint: The Long Road to Becoming the Next FDA Commissioner
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…
Firing Dr. Makary Solves No Problems….BUT Opens the Door for More Orderly Management and Decision-Making
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…