Mark I. Schwartz

Mr. Schwartz advises clients on drug, biologic and device compliance, quality, chemistry, manufacturing and control issues, combination product issues, and frequently serves as an expert witness in FDA-related litigation.

Mr. Schwartz joined the firm after spending close to 13 years at the Food and Drug Administration in various senior capacities. Most recently, Mr. Schwartz was CBER’s Deputy Office Director in the Office of Compliance and Biologics Quality.

Mr. Schwartz counsels clients on general FDA compliance matters, including deviations, investigations, recalls, field alert reporting, biological product deviation reporting, QA/QC issues, data integrity issues, shortage issues, OOS, stability and batch release issues, product labeling issues, adverse event reporting, product complaints, off-label issues, and general cGMP issues (Form 483s, Warning Letters and Untitled Letters), among others.

He also counsels clients on the requirements for establishing biologic biosimilarity and interchangeability, assists with the completion of CMC sections of INDs, BLAs, NDAs, as well as advising on the regulatory criteria for performing various manufacturing changes to biologics and drugs.

Mr. Schwartz has served as an expert witness in numerous drug, biologic and combination product cases, including:

• Antrim Pharmaceuticals, LLC v. Bio-Pharm, Inc., U.S. District Court for the Northern District of Illinois, No. 16-cv-00784;
• Par Pharmaceuticals, Inc., et al. v. QuVa Pharma, Inc., et al, U.S. District Court for the District of New Jersey, No. 3:17-cv-06115;
• Chartwell Therapeutics Licensing, LLC v. Citron Pharma, LLC, S. District Court for the District of Colorado, No. 1:16-dv-03181;
• Genentech, Inc. and City of Hope v. Amgen Inc., S. District Court for the District of Delaware. C.A. No. 18-924-GMS;
• In the matter of: Certain Botulinum Toxin Products and Processes for Manufacturing or Relating to Same. Medytox, Inc., Hugel, Inc., et al., U.S. International Trade Commission (ITC) Washington, D.C., Inv. No. 337-TA-1313;
• Janssen Pharmaceuticals, Inc., v. Emergent Biosolutions, Inc., and Emergent Manufacturing Operations Baltimore, LLC, American Arbitration Association No. 1-22-0002-5304;
• Microspherix LLC v. Merck Sharp & Dohme Corporation, Merck Sharp & Dome B.V., and Organon USA, LLC, S. District Court for the District of New Jersey Camden Vicinage, C.A. No. 17-cv-3984;
• Knight Therapeutics Inc. v. His Majesty the King, Tax Court of Canada, 2021-3165(IT)G;
• Apotex Corp. v. Hospira Healthcare India Private Limited; Hospira, Inc., Supreme Court of the State of New York, County of New York, Index No. 653460/2020;
• Lindis Biotech, GMBH v. Amgen Inc., S. District Court for the District of Delaware, No. 22-cv-00035-VAC;
• UMB Bank, N.A., v. Bristol-Meyers Squibb Company, U.S. District Court for the Southern District of New York, 21-vc-04897-JMF.

Mr. Schwartz was CBER’s Deputy Director in the Office of Compliance and Biologics Quality from 2012 to 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 (managing the Center’s compliance and enforcement matters) and the Director of the Division of Inspections and Surveillance (managing the Center’s inspection and surveillance process), as did CBER’s Associate Director for Manufacturing Science. Mr. Schwartz also worked closely with the Office’s two other divisions, the Division of Manufacturing and Product Quality and the Division of Biological Standards and Quality Control.

In his capacity as the Office’s Deputy Director, he advised the Commissioner, 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  and Chemistry, Manufacturing and Control (CMC) issues involving biologics and drugs. Mr. Schwartz also represented the Agency and the Center in various outside activities, including with other federal agencies and governments.

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 reviewed BPDRs and potential recall situations. He handled 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, and he worked on numerous CMC issues on behalf of the Office.

Prior to his tenure at CBER, Mr. Schwartz was Associate Chief Counsel for Drugs and Biologics (2008-2012), Associate Chief Counsel for Biologics (2005-2008) and Associate Chief Counsel for Foods (2003-2005). As Associate Chief Counsel for Drugs and Biologics he advised the FDA Commissioner, the Chief Counsel, CDER and CBER officials on a variety of constitutional, statutory, and regulatory issues involving drugs, biologics and medical devices. Mr. Schwartz was co-team leader for the Biologics team from 2007-2013, and co-team leader for the Biosimilars team from 2010-2013. He was also on the Biosimilars Implementation Committee from 2010-2013.

While Associate Chief Counsel for Drugs and Biologics, Mr. Schwartz’s day-to-day activities included providing advice on the regulation of drugs, biologics and medical devices on matters related to: inspection, compliance and enforcement; the approval process; postmarketing safety and regulatory issues; advertising and promotional labeling; orphan drug exclusivity; accelerated approval; and combination products. Mr. Schwartz’s particular areas of interest during that period included: biosimilar and interchangeable biologics; the regulation of HCT/Ps, cell and gene therapies, vaccines, blood products and blood derivatives; Hatch–Waxman generic drug approvals; partial AUC determinations; First Amendment issues (including off-label promotion, and commercial speech versus fully protected speech); and federal preemption.

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 was a member of the Food and Drug Law Journal Editorial Advisory Board from 2008-2011.  He has also written extensively, and has published editorials in the New York Times, International Herald Tribune, Wall Street Journal, Barron’s Magazine, Bloomberg, Forbes, Christian Science Monitor, National Post, Financial Times, and Globe & Mail, among others.