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 fifteen years 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 developed wide-ranging, national policies for drugs and biological products and solved regulatory problems 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's working group for the rule “Definition of the Term ‘Biological Product,” and was a subject-matter expert concerning reference product exclusivity for biological products on the agency's Exclusivity Board.

Dan’s 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. 

Civic and Professional Activities

  • 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.

Publications and Presentations

Publications

  • 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.

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 concerning exclusivity for a biologic with over $2 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. 
  • 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. 
  • Counseled 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.
  • Obtained dismissal of four state attorney-general investigations against a national medical device manufacturer as preempted by FDA approval.
  • Advised a publicly-traded pharmaceutical manufacturer in connection with removal of a boxed warning from its product label. 
  • Counseled a European pharmaceutical manufacturer concerning compliance problems detected during acquisition of two U.S. manufacturing facilities. 
  • 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.
  • Assisted 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).