Jennifer Schwartz

Jennifer Schwartz is an associate in the firm’s Food and Drug practice group.  She advises clients on a variety of regulatory matters involving the Food and Drug Administration, including issues related to drugs, devices, dietary supplements, foods, and tobacco.  Ms. Schwartz has particular experience representing FDA-regulated manufacturers challenging FDA’s actions in Administrative Procedure Act litigation.

Ms. Schwartz also teaches a Food and Drug Law course at American University’s Washington College of Law.

Representative Matters

• Represent pharmaceutical manufacturers in litigation against FDA challenging approval of generic products.
• Assist with FDA dispute resolution proceedings on behalf of pharmaceutical manufacturers adversely affected by certain agency actions.
• Assist pharmaceutical companies in complying with FDA regulations governing prescription drug marketing and advertising practices.
• Advise pharmaceutical manufacturer on state clinical-laboratory laws.
• Advise tobacco manufacturer regarding regulation of modified risk tobacco products.
• Represented pharmaceutical manufacturer in federal investigation of sales and marketing activities.
• Drafted Warning Letter response for over-the-counter drug product.
• Drafted citizen petition to FDA on behalf of pharmaceutical company.

Previous Experience

• Pharmaceutical Sales Representative (2003-2006)

Memberships and Affiliations

• Food & Drug Law Journal, Editorial Advisory Board, Member

Publications and Speeches

• "D.C. District Court Rules FDA Has Inherent Authority to Rescind 510(k) Clearance in "Rare Situation"," Covington E-Alert (4/26/2013), Co-Author
• "IOM Committee Holds Public Workshop Regarding Front-Of-Package Labeling Systems," Covington E-Alert (4/12/2010), Co-Author