The FDA’s Century-Long Campaign to Assure Safe Manufacturing (Part 2)
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 compared the situation to a large jigsaw puzzle with a few pieces missing, yet the picture and its meaning are crystal clear.
Unfortunately, there are significant barriers to getting those last few pieces in place. For the most part, we know what needs to be done, but we may lack the public support and political will to make that happen.
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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…
Spotlight: The Partnership for Safe Medicines (PSM)
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…
Compounding, Patient Safety, and the Vital Role of FDA Enforcement
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…
Spotlight: Americans for Medical Progress/Vital Role of Animals in Research
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…