Dan Orr is senior counsel at Wilson Sonsini Goodrich & Rosati, where he 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, has more than 20 years of experience concerning regulation of drugs, biologics, and medical devices.
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 is practicing virtually in Pennsylvania, where he is licensed.
Dan Orr is senior counsel at Wilson Sonsini Goodrich & Rosati, where he 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, has more than 20 years of experience concerning regulation of drugs, biologics, and medical devices.
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 is practicing virtually in Pennsylvania, where he is licensed.
- J.D., Vanderbilt University Law School
- M.A., University of Pennsylvania
- B.A., University of PennsylvaniaWith Distinction
- B.S., City University of New York
Cum Laude
- Adjunct Professor of Law, Drexel University, Thomas R. Kline School of Law
- Editorial Board, Food and Drug Law Journal, Food & Drug Law Institute
- Lifetime Member, Food & Drug Administration Alumni Association
- Member, Food and Drug Law Institute
- FDA Group Recognition Award, Biosimilar Education & 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
- Bar of the District of Columbia
- State Bar of New Jersey
- State Bar of New York
- State Bar of Pennsylvania
- U.S. Supreme Court
- U.S. Patent and Trademark Office
- J.D., Vanderbilt University Law School
- M.A., University of Pennsylvania
- B.A., University of PennsylvaniaWith Distinction
- B.S., City University of New York
Cum Laude
- Adjunct Professor of Law, Drexel University, Thomas R. Kline School of Law
- Editorial Board, Food and Drug Law Journal, Food & Drug Law Institute
- Lifetime Member, Food & Drug Administration Alumni Association
- Member, Food and Drug Law Institute
- FDA Group Recognition Award, Biosimilar Education & 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
- Bar of the District of Columbia
- State Bar of New Jersey
- State Bar of New York
- State Bar of Pennsylvania
- U.S. Supreme Court
- U.S. Patent and Trademark Office
Representative Experience
- 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.*
- Represented a Fortune 500 manufacturer in FDA dispute resolution concerning pediatric studies for a biologic with over $1 billion in annual sales.*
- 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 animal drug 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.*
*Denotes experience at another firm prior to joining Wilson Sonsini.
Representative Experience
- 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.*
- Represented a Fortune 500 manufacturer in FDA dispute resolution concerning pediatric studies for a biologic with over $1 billion in annual sales.*
- 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 animal drug 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.*
*Denotes experience at another firm prior to joining Wilson Sonsini.
Select Publications
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Co-author, “Clarifying FDA and USDA Jurisdiction over Animal Biological Products,” Wilson Sonsini Alert, September 29, 2025
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Co-author, “FDA’s Release of Complete Response Letters Raises Questions Related to Intellectual Property,” Wilson Sonsini Alert, September 26, 2025
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Co-author, “FDA Announces Rare Disease Evidence Principles to Accelerate Treatments for Ultra-Rare Genetic Diseases,” Wilson Sonsini Alert, September 23, 2025
- Co-author with J. Trinh and E. Yin, “How Courts Reviewed FDA Action Before Chevron and May Again After Loper Bright,” 79 Food & Drug Law Journal (in press)
- “Congress Must Fix the Inflation Reduction Act Before Millions Lose Treatment for Rare Diseases,” Yale Law & Policy Review Inter Alia, December 2023
- “How to Pick a Winning Patent,” 21(2) UCLA Journal of Law & Tech, 2017
- “International Discovery Agreements Can Facilitate the Transfer of Data from the European Union,” 200 New Jersey Law Journal 167, 2010
- Co-author with C. Guthrie, “Anchoring, Information, Expertise, and Negotiation: New Insights from Meta Analysis, 21(3) Ohio State Journal on Dispute Resolution 597, 2006
- Co-author with J. Ferrigno-Stack,“Childproofing on the World Wide Web,” 41 Jurimetrics Journal 465, 2001
Select Speaking Engagements
- Panelist, "The End of Chevron Deference: Navigating Federal Administrative Law in the Wake of Loper Bright," Seton Hall Law Review Symposium, February 2025
- Discussant, “Regulating on Shifting Sands: Analyzing the Impact of Recent and Upcoming Federal Court Decisions on FDA’s Authority,” Food and Drug Law Journal Symposium, November 2023
- Panelist, “How to Navigate the FDA Approval Process and Other Regulatory Issues,” SCBIO, December 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)
Select Publications
-
Co-author, “Clarifying FDA and USDA Jurisdiction over Animal Biological Products,” Wilson Sonsini Alert, September 29, 2025
-
Co-author, “FDA’s Release of Complete Response Letters Raises Questions Related to Intellectual Property,” Wilson Sonsini Alert, September 26, 2025
-
Co-author, “FDA Announces Rare Disease Evidence Principles to Accelerate Treatments for Ultra-Rare Genetic Diseases,” Wilson Sonsini Alert, September 23, 2025
- Co-author with J. Trinh and E. Yin, “How Courts Reviewed FDA Action Before Chevron and May Again After Loper Bright,” 79 Food & Drug Law Journal (in press)
- “Congress Must Fix the Inflation Reduction Act Before Millions Lose Treatment for Rare Diseases,” Yale Law & Policy Review Inter Alia, December 2023
- “How to Pick a Winning Patent,” 21(2) UCLA Journal of Law & Tech, 2017
- “International Discovery Agreements Can Facilitate the Transfer of Data from the European Union,” 200 New Jersey Law Journal 167, 2010
- Co-author with C. Guthrie, “Anchoring, Information, Expertise, and Negotiation: New Insights from Meta Analysis, 21(3) Ohio State Journal on Dispute Resolution 597, 2006
- Co-author with J. Ferrigno-Stack,“Childproofing on the World Wide Web,” 41 Jurimetrics Journal 465, 2001
Select Speaking Engagements
- Panelist, "The End of Chevron Deference: Navigating Federal Administrative Law in the Wake of Loper Bright," Seton Hall Law Review Symposium, February 2025
- Discussant, “Regulating on Shifting Sands: Analyzing the Impact of Recent and Upcoming Federal Court Decisions on FDA’s Authority,” Food and Drug Law Journal Symposium, November 2023
- Panelist, “How to Navigate the FDA Approval Process and Other Regulatory Issues,” SCBIO, December 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)
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