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, 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 traditional pharmaceutical manufacturers and compounding entities—reflects that quality failures are systemic risks that require systemic solutions.
“Regulation of US Drug Manufacturing Since 1900” can be viewed as an almost-completed jigsaw puzzle. While a few pieces may still be missing, the picture is clear: FDA has the authority and the intent to require all drug manufacturers to conform to its rules and standards. There is no room for, or benefit from, having two pathways with different ru…
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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…
Speeding Innovative Medicines to Market: Any Delay Matters to Patients
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…