Essays · The Hillman Letter
Long-form writing on FDA regulatory strategy, frontier therapeutics, family office capital, and healthcare compliance. Thirty years of operating experience translated into essays you can read in twenty minutes. Seven essays published. New essays weekly.
The designation is wasted if the role is fuzzy, the file is a theory, and the opinion is asked to outrun the operating record.
The Department of Justice recovered 6.8 billion dollars under the False Claims Act in fiscal year 2025, the highest single year total in the statute's history.
The Paradigm Peptides sentencing was not a peptide story.
Full archive on thehillmanletter.substack.com.
The False Claims Act, Anti-Kickback, Stark, HIPAA, EKRA, and qui tam whistleblower exposure, and the infrastructure that turns statutory knowledge into a defensible compliance record.
The FTC just handed the telehealth industry an inspection checklist.
The pattern was the same across five programs. In case you are running one of the next ones.
The Dallas-Fort Worth biotech ecosystem has been compounding for three decades.
Why most exosome programs pick the wrong FDA pathway, and what the BLA route actually demands.
A ten-year venture fund has to return capital on a schedule. The FDA does not care about your schedule.
Every enforcement action I have served on involved a pattern visible eighteen to thirty-six months before.
Five lessons I would tell my younger self if I could.