Firing Dr. Makary Solves No Problems….BUT Opens the Door for More Orderly Management and Decision-Making
No matter what you think of Dr. Makary or his time in office, his firing (or forced resignation) doesn’t change the fundamental difficulties of being FDA Commissioner under President Trump and HHS Secretary Kennedy. His departure gives the appearance of change, but leaves untouched the fundamental tension between FDA’s statutory, functional, and moral responsibilities and the goals, governing style, and legacy of this Administration.
Dr. Makary’s temporary successor, Kyle Diamantas, faces the same impossible situation. However, he will probably have the opportunity to implement more orderly management structures and decision-making processes, both of which would be welcome improvements.
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.
FDA Matters does not report the news….we provide analysis of what’s behind the news.
FDA Matters advocates for a more effective, efficient, and fair FDA.
FDA Matters has been featured in:
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…
Spotlight: Advanced Research Projects Agency for Health (ARPA-H)
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…
Squaring the Circle: The Seemingly Impossible Task of Fixing the US Food Supply
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….