Hyman Phelps and McNamara
Mark Schwartz
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(202) 737-9632
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Practice Areas
Prescription Drugs and Biologics
Medical Devices
Corporate Transactions
Drug Supply Chain and Distribution
Tissue Products

LL.M., Duke University School of Law
LL.B., Ecole de Droit de l’Université de Sherbrooke
B.S., McGill University

Bar Admissions
District of Columbia

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Mr. Schwartz advises clients on drug, biologic and device compliance, as well as on regulatory issues. He joined the firm after spending close to 13 years at the Food and Drug Administration in various capacities. 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 (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 He participated in dozens of regulatory meetings with industry, and reviewed draft guidance documents and regulations for Office clearance, and he worked on numerous CMC issues on behalf of the Office.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.

Awards & Recognition
• Director’s Distinguished Service Award as a member of the team that reviewed the applications for the vaccines Trumenba and Bexsero.
• Commissioner’s Award of Excellence for providing excellent legal counsel to high level agency officials on a wide range of complex and significant matters involving biological products.
• Outstanding Service Award for outstanding performance in providing legal services to FDA on significant and complex issues, primarily involving biologics and conventional human drugs.
• Commissioner’s Special Citation for exceptional performance and leadership in carrying out FDA’s mission to ensure the safety of vaccines and other drug products.
• Award of Merit for extraordinary and collaborative efforts in responding to the public health threat posed by potentially unsafe human tissue products in commerce.

Speaking Engagements
• Allergenic Products Manufacturers’ Association Annual Meeting (Fall 2015).
• Vaccine Roundtable Annual Meeting (Spring 2015).
• Training for ORA Investigators (Summer 2014).
• Panelist Representing Office of Chief Counsel at Part 15 hearing on Approval Pathway for Biosimilars (November 2010).
• Speaker Representing FDA at DIA’s Biosimilars conference held in London (September 2009).
• Panelist at ABA Administrative Law conference in Washington, D.C. on "Use of Journal Articles in Medical Product Promotion" (October 2008).
• Panelist at ABA Annual Law conference in New York, concerning how best to regulate biotech drug approval ("Beyond Frankenstein" - August 2008).

Articles / Publications    -    see more articles
•  Assessing the FDA's Safety Drive,  August 1, 2016

•  Too Much Precaution About Biotech Corn,  March 17, 2008

•  Consumer Drug Advertising: Can Congress Constitutionally Impose a Moratorium?,  March/April 2008

•  To Ban or Not to Ban - That Is The Question: The Constitutionality of a Moratorium on Consumer Drug Advertising,  March 2008

•  Genetically Safer: Europe Continues to Resist Genetically Modified Crops, Though They're Actually Safer Than Conventional Ones,  February 13, 2008

Speaking Engagements   
•  9th Annual Pharmaceutical & Device Manufacturing & Quality Assurance Forum, Responding to Increasing Regulatory Scrutiny & Varying Standards Interpretations, January 29-30, 2018
•  Webinar: Marketing Drugs, Medical Devices and Foods in the U.S. – What you need to know, November 8, 2017
•  Introduction to US Biologics and Biosimilars Law and Regulation, Regulation of Biological Manufacturing, October 4-5, 2017
•  9th Annual Pharmaceutical & Device Manufacturing & Quality Assurance Forum, Responding to Increasing Regulatory Scrutiny & Varying Standards Interpretations, January 29-30, 2017
•  International Pharmaceutical and Medical Device Supply Chains Imperiled Like Never Before, September 14, 2016

Blog Posts    -    see more blog entries
•  Pharmaceutical Manufacturing in Puerto Rico after Maria– Where does it go from here?,  September 28, 2017
•  A Change in Direction on Stem Cell Policy? It’s About Time,  August 28, 2017
•  Another Brick in the Wall: A New Commitment Implementing the Mutual Recognition of Inspections,  August 24, 2017
•  Word to the Wise (Drug Manufacturer): Don't Use Your Manufacturing Equipment to Produce Toxic, Non-Pharmaceutical Products,  August 8, 2017
•  cGMP Problems Shrink the DepoCyt Chemotherapy Market,  July 13, 2017