Dan Orr brings an insider’s perspective to helping clients solve drug and biotech regulatory challenges. Dan, a former U.S. Food & Drug Administration Regulatory Counsel, brings more than a decade of life sciences regulatory experience to the Womble Bond Dickinson team.
Dan guides clients in regulatory and policy issues in the pharmaceutical and biotech sectors, such as:
- Exclusivity for drugs and biological products,
- Life-cycle management,
- Product classification and jurisdiction, and
- FDA dispute resolution.
At the FDA, Dan advised the agency’s Center for Drug Evaluation & Research (CDER). In that role, he developed wide-ranging, national policies for drugs and biological products and resolved regulatory issues in a portfolio of products with combined annual sales of more than $37 billion. Dan was the lead Regulatory Counsel for multiple approvals of new drugs, biological products, biosimilars and generic drugs.
Dan also chaired the FDA working group for the proposed rule “Definition of the Term ‘Biological Product,” and was a subject-matter expert concerning reference product exclusivity for biological products on FDA’s Exclusivity Board.
Civic and Professional Activities
- Lifetime Member, Food & Drug Administration Alumni Association.
- Committee Member, Medical Products Committee, Food & Drug Law Institute.
- Member, American Intellectual Property Law Association.
Publications and Presentations
- 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).
- Panelist, “How to Navigate the FDA Approval Process and Other Regulatory Issues”, SCBIO, December 1, 2020
Honors and Awards
- 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.
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 FDA concerning exclusivity for a biologic with over $2 billion in annual sales.
- Defended a European pharmaceutical manufacturer in a $110 million suit that claimed the client’s manufacturing processes violated FDA’s Current Good Manufacturing Practices.
- Conducted due diligence of FDA issues for a Fortune 500 client in acquiring a portfolio of nucleic acid therapy patents.
- Obtained dismissal of four state attorney-general investigations against a national medical device manufacturer as preempted by FDA approval.
- Assisted a Chinese medical products manufacturer in reconditioning product labels to obtain release from FDA and U.S. Customs detention.
- Advised several regional physician practice groups concerning the scope of permissible “off-label” promotion for an FDA-approved medical device.
- Counseled an international pharmaceutical client concerning FDA compliance issues in acquiring a U.S. manufacturing facility.
- Renegotiated pricing of more than $12 million in brachytherapy products at arbitration on behalf of a national oncotherapy manufacturer.