D. Kyle Sampson

Kyle Sampson counsels boards, C-suite executives, General Counsel, and Chief Compliance Officers in the biotechnology, pharmaceutical, and life sciences industries on their most complex regulatory, compliance, and enforcement challenges. He draws on decades of experience in both private practice and senior government service to help clients navigate the intersection of law, regulation, and policy.

Kyle advises pharmaceutical, biologics, medical device, cosmetics, and dietary supplement companies on the full specturm of FDA-regulated activity -- from product development and approval through manufacturing, distribution, labeling, and marketing. He helps companies build and strengthen compliance programs addressing off-label promotion, the anti-kickback statute, and healthcare fraud and abuse. He regularly trains senior leaderhsip and commercial teams on regulatory obligations, and when compliance issues suface, he leads internal investigations and develops remediation strategies designed to minimize enforcement risk.

Kyle represents FDA-regulated companies in high-stakes enforcement proceedings, including FDA inspections, Warning Letters, injunctions, consent decrees, criminal investigations, debarment proceedings, and civil seizures. He also advocates for clients before FDA, the Drug Enforcement Administration, the U.S. Department of Justice, State Attorneys Genral, and members of Congress -- drawing on relationships and experience devleoped during his years in government.

Before entering private practice, Kyle held senior appointed positions at the White House, the Justice Department, and the U.S. Senate, giving him first-hand knowledge of how federal agencies and lawmakers approach regulatory and enforcement priorities. That background enables him to anticipate government action, shape compliance strategy, and position clients for the best possible outcome when they face regulatory scrutiny.