Pharmaceutical Regulation, Compliance & Policy, Part 2: Navigating the New Enforcement Environment – FDA Watch
In this second part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with John Claud, Counsel at HPM; Peter Dickos, Counsel at HPM; and Andrew Hull, Director at HPM. Together, they discuss the current enforcement environment at FDA; foreign inspections of pharmaceuticals and how companies should respond to 483s; False Claims Act theories for liability, specifically in areas such as cybersecurity, tariffs, DEI compliance, and CID/subpoena responses; key considerations in determining whether to enter into a consent decree with the agency; trends in enforcement discretion; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
About Our Guests
John Claud
John Claud counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. He also advises clients on matters related to compliance with the Controlled Substances Act and DEA regulations, and matters involving drug compounding, telehealth, and telemedicine.
Claud is a 15-year veteran of the Department of Justice. Prior to joining Hyman Phelps, he most recently served as the Assistant Director of the Consumer Protection Branch, where he led the Corporate Compliance and Policy Unit. Claud has prosecuted and supervised complex criminal and civil trial litigation and investigations under the Food, Drug and Cosmetic Act, Federal Trade Commission Act, Consumer Product Safety Act, and Federal data privacy laws. He also held leading roles in DOJ’s response to three recent and significant national health crises, including the COVID -19 pandemic. Claud is also an accomplished trial lawyer, having started his career as an Assistant District Attorney in Manhattan before joining DOJ. He is a frequent public speaker on matters of government enforcement strategies under the FDCA as well as corporate compliance best practices.
Andrew Hull
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, 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, 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, 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, Hull was an associate at Hyman, Phelps & McNamara. He 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.
Peter Dickos
Peter Dickos draws on nearly a decade of high-level government service to help clients navigate complex regulatory and litigation challenges involving the U.S. Food and Drug Administration (FDA). Prior to joining Hyman, Phelps & McNamara, Dickos served for over six years in FDA’s Office of Chief Counsel, first as an Assistant and then Associate Chief Counsel. During that time, he led and supported the agency’s litigation efforts in critical matters involving drug approvals, exclusivity disputes, enforcement, and administrative law challenges.
Dickos’ deep understanding of FDA’s internal processes and priorities enables him to deliver strategic counsel and litigation support to clients across the life sciences industry. He advises pharmaceutical, biotech, and tobacco companies on regulatory compliance, advocates for them in administrative and civil litigation, and provides proactive guidance on product development, enforcement risk, and agency engagement.
Prior to his FDA tenure, Dickos practiced at a major Washington, DC, litigation firm and clerked for the Honorable Mark R. Hornak of the U.S. District Court for the Western District of Pennsylvania. His clients benefit from his blend of government insight, litigation skill, and practical advice grounded in first-hand regulatory experience.
FDA Watch Podcast 