Dan Orr brings an insider’s perspective to helping clients prevent and solve problems with the U.S. Food & Drug Administration. Dan, a former FDA Regulatory Counsel, brings more than twenty years of experience to the Womble Bond Dickinson team concerning regulation of drugs, biologics, medical devices, food, and dietary supplements.
At the FDA, Dan developed wide-ranging, national policies for drugs and biologics and solved regulatory problems in a portfolio of products with combined annual sales of over $37 billion. He also served on the agency’s Exclusivity Board and is frequently sought as an expert concerning regulatory exclusivity and FDA-related patent issues.
Dan represents clients before the FDA and in related transactions and litigation, such as life-cycle management, rulemaking and petitions, compliance issues, FDA dispute resolution, and regulatory due diligence.
He also serves on the Editorial Board of the Food & Drug Law Journal. Dan’s own legal scholarship has been cited more than 150 times including in the Harvard Law Review, the Yale Law Journal, and by the National Academies of Science.
Representative Experience
Any result the lawyer or law firm may have achieved on behalf of clients in other matters does not necessarily indicate similar results can be obtained for other clients.
- Represented a Fortune 500 biopharmaceutical manufacturer before the FDA regarding exclusivity for a biologic with over $6 billion in annual sales.
- Advised a Fortune 500 client concerning life-cycle management of drugs and biologics acquired in an over $50 billion corporate merger.
- Counseled multiple national and regional laboratory clients concerning FDA regulation of laboratory developed tests.
- Assisted a publicly traded health care company to maintain FDA compliance in acquiring a national dietary supplement company.
- Represented a Fortune 500 manufacturer in FDA dispute resolution concerning pediatric studies for a biologic with over $1 billion in annual sales.
- Guided a multinational food manufacturer concerning compliance with FDA packaging regulations for imported products.
- Assisted a publicly traded client in obtaining a Regenerative Medicine Advanced Therapy designation for an orphan designated cell therapy.
- Assisted a Fortune 500 client in demonstrating clinical superiority to overcome orphan exclusivity held by a competing product.
- Defended a European pharmaceutical manufacturer in a $110 million suit that claimed the client’s manufacturing processes violated the FDA’s Good Manufacturing Practice regulations.
- Advised a publicly traded pharmaceutical manufacturer in obtaining FDA approval to remove a boxed warning from its product label.
- Counseled a European pharmaceutical manufacturer concerning compliance problems detected during acquisition of two U.S. manufacturing facilities.
- Obtained dismissal of four state attorney-general investigations against a national medical device manufacturer as preempted by FDA approval.
- Assisted a Chinese dietary supplement manufacturer in reconditioning product labels to obtain release from FDA and U.S. Customs detention.
- Guided three regional physician practice groups concerning the scope of permissible “off-label” promotion for an FDA-approved medical device.
- Aided multiple clients in responding to requests for product samples from generic and biosimilar manufacturers under the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act).
Professional & Civic Engagement
- Editorial Advisory Board, Food and Drug Law Journal, Georgetown University Law School and Food & Drug Law Institute.
- Lifetime Member, Food & Drug Administration Alumni Association.
- Member, Food and Drug Law Institute.
Thought Leadership
Publications
- Daniel E. Orr, Congress Must Fix the Inflation Reduction Act Before Millions Lose Treatment for Rare Diseases, 42 YALE LAW & POLICY REV. 1 (2023).
- Daniel E. Orr, How to Pick a Winning Patent, 21 UCLA J. OF LAW & TECH 2 (2017).
- Daniel E. Orr, International Discovery Agreements Can Facilitate the Transfer of Data from the European Union, 200 N.J.L.J 167 (2010).
- Dan Orr & Chris Guthrie, Anchoring, Information, Expertise, and Negotiation: New Insights from Meta Analysis, 21 OHIO ST. J. ON DISP. RES. 597 (2006).
- Daniel Orr & Josephine Ferrigno-Stack, Childproofing on the World Wide Web, 41 JURIMETRICS J. 465 (2001).
Presentations
- Panelist, “How to Navigate the FDA Approval Process and Other Regulatory Issues,” SCBIO, December 1, 2020.
- Guest Lecturer, “From Lab to Clinic: Early-Stage Interactions with the FDA,” Georgetown University Medical Center, September 2019.
- Instructor and Curriculum Advisor, “Introduction to Drugs and Biologics Regulation,” Food & Drug Law Institute, 2018 – 2019 (3 sessions).
- Panelist, “Regulatory and IP Issues for Immunotherapies Including CAR-T and Antibody Technologies,” American Intellectual Property Law Association, October 2018.
- Instructor, “Introduction to Drug Law,” FDA Training Academy, 2014 – 2016 (3 sessions).
Honors and Awards
- FDA Group Recognition Award, Biosimilar Education and Outreach, 2017.
- FDA Group Recognition Award, Quality Metrics, 2017.
- FDA Group Recognition Award, Approval of Glatopa, First Generic Drug to Copaxone, 2016.
- Equal Justice Medal, Legal Services Corporation of New Jersey, 2008.
