Hyman Phelps & McNamara P.C. (“HP&M”) is pleased to announce that Mark I. Schwartz has joined the firm as Of Counsel. Mr. Schwartz advises clients on biologic, drug, and device compliance, as well as on regulatory issues. He joined the firm after spending close to 13 years in various capacities at the Food and Drug Administration. Most recently, Mr. Schwartz was CBER’s Deputy Director in the Office of Compliance and Biologics Quality (2012-2015), an office with approximately 140 staff members. Two of the Office’s four division directors reported directly to Mr. Schwartz, namely, the Director of the Division of Case Management and the Director of Inspections and Surveillance.
In his capacity as Deputy Director, he advised the Center Director, the Director of the Office of Compliance and Biologics Quality, as well as various offices within CBER and CDER on a variety of compliance issues involving medical products. Mr. Schwartz also represented the Office and the Center in various FDA and outside activities.
Mr. Schwartz’s day-to-day activities included the review of draft 483s, warning letters, untitled letters and NOIRs, among others, for issuance, and determinations as to whether a regulatory letter, enforcement action or other action would be warranted. Mr. Schwartz also worked on BPDRs and potential recall situations, he reviewed complaints and adverse events, and cleared all significant advertising and promotional labeling matters for the office. He participated in dozens of regulatory meetings with industry, and reviewed draft guidance documents and regulations for Office clearance.
Prior to his tenure at CBER, Mr. Schwartz was Associate Chief Counsel for Biologics and Drugs (2008-2012), Associate Chief Counsel for Biologics (2005-2008) and Associate Chief Counsel for Foods (2003-2005). Before joining FDA, Mr. Schwartz was a commercial litigator in Washington, D.C., and prior to that, in his native Montreal, Canada. He has law degrees from Duke University School of Law and l'Université de Sherbrooke (Canada), as well as a Bachelor of Science degree from McGill University (Canada).
Mr. Schwartz has been an Adjunct Professor of Food and Drug Law at both George Mason University School of Law and Howard University School of Law, and he has published op-eds and articles on FDA-related issues in the International Herald Tribune/The New York Times, Barron’s Magazine, Financial Post (Canada), the Food and Drug Law Journal and UPDATE Magazine, among others. Mr. Schwartz also served as a member of the Food and Drug Law Journal Editorial Advisory Board from 2008-2011.