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The FDA: the agency the Trust Network kept walking into

Hamburg's meeting and the Seyfert-Margolis pilot; commissioners Califf, Gottlieb, Woodcock, McClellan; the division chiefs of CDER, CDRH and CBER

About this entry

This is Jonathan Hare's account, with its provenance shown. The person or organization named has not yet claimed or corrected it.

Organization

What this is

The Food and Drug Administration is, in this record, the agency the Resilient Network Systems work kept walking into: the Hamburg meeting and the FDA-wide pilot assigned to Vicki Seyfert-Margolis; and, in the years since, numerous meetings by Jonathan Hare and Jack Lewin with almost every commissioner — Robert Califf, Scott Gottlieb, Janet Woodcock, and many times Mark McClellan — and close work with the division chiefs of CDER, CDRH and CBER (S-192). Around it, in the same account: the Secretaries of HHS, administrators of CMS, the NIH under Francis Collins (and Florence Haseltine's NIH world), AHRQ under Carolyn Clancy, and the VA. Individuals get pages as the email archive names them; this page is the frame.

The graph

Connected from here

There is no single root. This is one view of the graph, from this node — what you see depends on where you enter and what you are looking for.

the 2009-era meeting

Peggy Hamburg: a drink at the Aspen bar, and three hours at the FDA

Met at the Aspen Health VIP bar c. 2009, before knowing who she was; her food-safety emergency became the FDA meeting where Eric Haseltine said RNS was the only viable approach he had seen

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the pilot

Vicki Seyfert-Margolis carried the pilot — the FDA's innovation scientist

Hamburg's senior advisor for science innovation and policy; assigned the FDA-wide pilot; later a patient-data founder

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commissioner

Robert Califf ran the FDA twice — Duke's trial engine built him

Founder of the Duke Clinical Research Institute; commissioner 2016–17 and again from 2022; the evidence-infrastructure commissioner

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commissioner

Scott Gottlieb, the commissioner who moved fastest — and writes it all down

FDA 2017–19; AEI; the Pfizer board; the most public explainer of drug regulation of his generation

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CDER; acting commissioner

Janet Woodcock ran drug regulation itself for three decades

CDER's long-serving director; acting commissioner 2021; the institutional memory of American drug review

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commissioner

Mark B. McClellan, whom I know well — Brookings, then Duke-Margolis, and many meetings since

FDA commissioner and CMS administrator in the 2000s; Brookings; founding director of the Duke-Margolis Center — met at Aspen Health c. 2009, and many times since with Jack Lewin

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the meetings

Jack Lewin: founding chair of the EP3 Foundation, and the path to Bertolini — now leading Hawaii

The physician-executive whose reach runs from Aetna's CEO to a $120m statewide transformation

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the pilot's subject

Resilient Network Systems: Esther Dyson, the ODNI, and the IRS deployment

The trust network, and the intelligence years

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Provenance

Where this came from

Everything above is a distillation. The primary source is published in full, so that any claim on this page can be walked back to what was actually said — and where the two differ, the source governs.

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What is missing, and how to fix it

This entry is deliberately incomplete. The gaps below are the things only certain people can settle — and settling one is a contribution like any other: recorded, timestamped and attributed to whoever made it.

If you were there

Correct anything wrong, add what only you know, or claim this entry as your own. Write to evidence@qpncatalyst.io and Jonathan directly (both are on the button) — a timestamped confirmation comes back with your submission attached, as your own independent record. No account, no permission, no institutional standing required.

Public contributions earn Publicity Premium; bringing others who were there earns Cascade Premium. Everything is valued retrospectively as outcomes verify, so nothing has to be priced up front.

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Where this leads

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