Expertise in all things FDA
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Expertise in all things FDA
Overview
Andrew Hull represents companies and individuals facing government investigations, enforcement actions, whistleblower complaints, and inspections, and counsels clients on risk mitigation and readiness for such actions. Most recently an Assistant U.S. Attorney, he uses his experience investigating and prosecuting violations of the FDC Act, the Controlled Substances Act, the False Claims Act, and other federal healthcare laws to now defend clients facing criminal, civil, and administrative enforcement actions. As a litigator, Mr. Hull’s civil and criminal trial practice in federal court and before DEA’s Office of Administrative Law Judges enables him to expertly advise clients through the entire course of a federal investigation and to zealously defend them in court, should it come to that. He has negotiated dozens of complex settlements using his in-depth knowledge of the life sciences and healthcare space and government regulation at DOJ, FDA, DEA, HHS, and CMS to obtain successful resolutions.
As a counselor, Mr. Hull uses his enforcement and litigation experience to advise clients on compliance with FDA and DEA requirements across the food, drug, and device supply chains, including training for inspection-readiness, developing best-in-class compliance programs, and responding to administrative actions.
As an Assistant U.S. Attorney in the Western District of Michigan, Mr. Hull was the Affirmative Civil Enforcement Coordinator and the Healthcare Fraud Coordinator in the office’s Civil Division, spearheading a large volume of False Claims Act qui tam investigations and other enforcement actions. He also worked on numerous parallel criminal-civil healthcare prosecutions and tried multiple criminal cases to jury verdict. Prior to his time as a federal prosecutor, Mr. Hull was an associate at Hyman, Phelps & McNamara. Mr. Hull started his legal career as a law clerk to DEA Chief Administrative Law Judge John J. Mulrooney, II, a position he was awarded through the Department of Justice’s Attorney General’s Honors Program.