Robert A. Dormer
Robert A. Dormer is one of three founding members of Hyman, Phelps & McNamara, P.C. He has been an integral part of the firm's growth and expansion in all areas of FDA law. He advises clients on a wide range of issues throughout the product lifecycle including development and approval, compliance, and enforcement.
From 1976 to 1979, Mr. Dormer served in FDA's Office of Chief Counsel. He was an Associate Chief Counsel for Enforcement and Associate Chief Counsel for Radiological Health. Mr. Dormer was responsible for counseling what was then known as the Bureau of Radiological Health, which is now part of FDA's Center for Devices and Radiological Health. He also represented the FDA in civil and criminal litigation throughout the country. Prior to joining the FDA, he served as an attorney for the White House Special Action Office on Drug Abuse Prevention.
Mr. Dormer regularly counsels pharmaceutical clients on Hatch-Waxman patent and exclusivity issues, orphan drugs, and biosimilar regulation and policy. He also has extensive expertise with post-marketing issues such as advertising and promotion, and good manufacturing practices for drugs and medical devices.
Mr. Dormer is the author of three book chapters on food and drug law as well as numerous published articles. He regularly speaks on food and drug law at legal and regulatory conferences and provides expert testimony.
Prescription Drugs & Biologics
• Develops strategies around patent and exclusivity matters, including Hatch-Waxman and Orange Book listings.
• Assists with INDs, NDAs, and ANDAs.
• Advises clients on user fees and GAIN exclusivity.
• Reviews materials regarding advertising and promotion for prescription drugs.
• Provides counsel on REMS.
• Develops strategies for 510(k) clearance and PMA approval.
• Advises on compliance with post-market regulations, including establishment registration and listing, adverse event reporting, labeling and advertising, Part 806 reporting, and QSR requirements.
• Advises clients on requirements pertaining to labeling and advertising claims in print and electronic media.
• Counsels clients on FDA and state inspections, specifically QSR and GMP.
• Manages responses to warning letters, and FDA Form 483s.
• Advises on enforcement matters, including responses to FDA Form 483s, warning letters, voluntary product recalls, consent decrees, preliminary injunctions.
• Conducts due diligence reviews for companies engaged in mergers, acquisitions, and other corporate matters.
• Assists companies with FDA-related aspects of commercial agreements, including supply, distribution, and manufacturing agreements.
• American Bar Association
• Federal Bar Association
• Member, Editorial Advisory Board, Medical Product Outsourcing
• Army veteran, 1968 - 1970
Awards & Recognition
• The Washingtonian, Top Lawyers: Food and Drug, 2014
• Super Lawyer, Washington, D.C., Food & Drugs, 2007 - 2015
• LMG Life Sciences, Life Science Stars, 2013
• The International Who's Who of Business Lawyers (Life Sciences), 2008-2014
• LMG Life Sciences, Life Science Stars, 2014
• Super Lawyer, Washington, D.C., 2014
• The International Who's Who of Business Lawyers (Life Sciences), 2014 - 2015
Articles / Publications
FDA Amendments Act - HPM Issues Detailed Summary and Analysis,
District Court Rules on Simvastatin 180-Day Exclusivity,
May 5, 2006
FDA's Unauthorized User Fee Money Grab,
August 12, 2005
see more speaking engagements
American Society of Gene & Cell Therapy Annual Meeting, May 13-16, 2015
Evidentiary Criteria for Accelerated Approval of New Medicines
Florida Medical Manufacturers Consortium, May 4-5, 2015
5/4 Panel Member: "Current Trends in FDA Inspection & Enforcement"
Florida Medical Manufacturers Consortium (FMMC) Annual Florida Medical Device Symposium, May 19 - 20, 2014
Co-presenter for session International Regulatory Updates: Asia & Japan
Florida Medical Manufacturers Consortium (MMC) Medical Device Symposium, May 6 - 7, 2013
Best Practices in dealing with FDA Inspections Webinar, March 20, 2013
Every Breath You Take . . . FDA is Watching You!,
March 5, 2014