Naomi J. L. Halpern

Practice Areas

Naomi Halpern’s practice involves advising clients on a broad range of regulatory issues involving the Food and Drug Administration (FDA) with respect to pharmaceuticals (including branded and generic prescription and over-the-counter drugs), medical devices, foods, cosmetics and dietary supplements. She also advises on the laws and regulations relating to consumer products administered by the US Consumer Product Safety Commission (CPSC).

Client Work

Naomi counsels clients on issues relating to all phases of product development and approval, from the investigational stage to regulatory compliance and post-marketing, as well as on rulemaking and enforcement proceedings. She also has experience in evaluating and advising with respect to marketing strategies for new products (including review and counseling on advertising and promotional materials and strategies), reporting and recordkeeping requirements, clinical trial requirements, recalls and market withdrawals, drug and device listing and registration, user fees and orphan therapy issues.

Additionally, she counsels clients and has significant experience with laws and regulations of the CPSC, as well as with both federal and state laws related to medical privacy.

Previous Work

Prior to joining Arent Fox, Naomi was a partner in the Washington office of a New York-based law firm specializing in intellectual property and regulatory law and counsel at a Washington-based boutique law firm specializing in FDA and USDA law.

Professional Activities

Naomi is a member of the American Bar Association and the Administrative Law and Regulatory Practice Section. She is also a member of the Editorial Advisory Board for the Update Magazine, published by the Food and Drug Law Institute.

Publications, Presentations and Recognitions

Naomi has published the following articles:

• “180-Day Exclusivity: Forfeiture Decisions by FDA.” FDLI Update: Food and Drug Law, Regulation and Education (September/October 2009).
• “Update on Statutory Requirements for Handling Citizen Petitions Seeking To Delay Generic Approvals.” FDLI Update: Food and Drug Law, Regulation and Education (July/August 2008).
• “Implications of DHHS Medical Privacy Rule for Pharmaceutical and Medical Device Manufacturers.” FDLI Update: Food and Drug Law, Regulation and Education (November/December 2002).
• “Medical Privacy Compliance and Healthcare Marketing.” Medical Marketing & Media (May 2002). Co-authored this publication with Karen Harned.
• “FDA Regulation of Telemedicine Devices.” Food and Drug Law Journal (1997). Co-authored this publication with Peter Reichertz.

Bar and Court Admissions

District of Columbia Bar
Maryland Bar

Education

The George Washington University Law School, JD, with honors, 1992

• Member of The George Washington University Law Review

University of Michigan, BA with high honors and with distinction, 1985

Life Beyond the Law

When not working, Naomi spends most of her time with her family. She and her husband enjoy taking their children to their baseball and basketball games, as well as ice skating, fencing and music lessons. Additionally, she and her family volunteer frequently at the DC Central Kitchen, the Interfaith Works Clothing Center and at the Manna Food Center. In any remaining spare time, Naomi enjoys reading, gardening and playing with her Cavalier King Charles spaniel.