MICHAEL VARRONE draws on over two decades of experience at the U.S. Food and Drug Administration (FDA) to advise clients through critical issues of FDA compliance, enforcement, and regulation. His ability to adeptly navigate regulatory complexities, as well as his unique perspective into the intricate relationships between key federal authorities, allows him to provide crucial insight into the issues that arise across the full spectrum of policies and products regulated by the FDA.
During his tenure at the FDA, Mike served in several leadership roles, including Acting Deputy General Counsel in the Department of Health and Human Services (HHS) Office of the General Counsel, Health Policy Advisor to the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP), and Senior Counsel in FDA’s Office of the Chief Counsel. As Acting Deputy General Counsel of HHS, Mike gained insight into the relationships between FDA and HHS as well as the White House, the U.S. Department of Justice (DOJ), and the Centers for Disease Control and Prevention. His oversight of FDA legal matters for the Department encompassed many critical areas, including food safety and pre-market review of drugs, devices, and tobacco products. Mike played a critical role in shaping FDA-related policy and legislation for the U.S. Senate during the COVID-19 pandemic. In this role, he helped craft provisions in the Coronavirus Aid, Relief, and Economic Security (CARES) Act related to interruptions and permanent discontinuances in drug manufacturing, risk management plans for drugs, reporting of manufactured drugs, and medical device shortages.
Within the FDA’s Office of the Chief Counsel, Mike was a trusted legal advisor to FDA officials and adeptly handled a variety of federal court cases and administrative actions. Mike advised both FDA executives and field employees on compliance-related matters across the spectrum of products regulated by the FDA. Most recently, he led FDA officials in developing policies for oversight tools, including Remote Regulatory Assessments of foreign and domestic manufacturing establishments, for all FDA-regulated products. Mike also regularly taught courses to FDA employees related to drugs, medical devices, and dietary supplements.
His federal court cases comprised criminal and civil enforcement actions and defensive litigation arising under the Administrative Procedure Act. Mike’s criminal enforcement actions included investigating and prosecuting individuals and entities for violations of the laws governing the manufacturing, labeling, and distribution of human and animal drugs, medical devices, biological products, food and dietary supplements, and cosmetics. Mike was designated by the U.S. Department of Justice (DOJ) a Special Assistant United States Attorney in several districts for the investigation and prosecution of criminal cases under the Federal Food, Drug, and Cosmetic Act and related laws. He also directed the Health Care Fraud and Abuse Control (HCFAC) Program for FDA’s Office of the Chief Counsel and assisted in resolving any civil False Claims Act cases related to his prosecutions involving food, drugs, and medical devices. His civil enforcement actions included bringing seizures and injunctions in federal court for violations of the current Good Manufacturing Practices (cGMP) regulations for drugs and violations of the Quality Systems (QS) regulation for medical devices.
Mike has distinguished himself as a respected legal advocate and advisor in food and drug law. His hallmark contributions to the field of food and drug law have earned him various honors, including the “FDA Award of Merit,” the “FDA Commissioner’s Award of Excellence,” and the “FDA Outstanding Service Award,” Special Commendation from the DOJ’s Civil Division, and the “Gaston L. Gianni Better Government Award” from the Council of the Inspectors General on Integrity and Efficiency.
*Admitted only in Missouri; practicing law in the District of Columbia under the supervision of principals of the firm who are members in good standing of the D.C. Bar.