U.S. Food & Drug Administration Regulatory Counsel Daniel Orr will return to private practice at Womble Bond Dickinson, giving firm clients an insider’s perspective on drug and biotech regulatory and policy issues.
Orr will join the firm’s D.C. office where he will counsel clients on FDA regulatory matters. He will work with Womble Bond Dickinson clients on regulatory and policy issues in the pharmaceutical and biotech sectors, such as exclusivity for drugs and biological products, life-cycle management, product classification, and biosimilars-related issues.
Since joining the FDA in 2013, 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 also advised CDER concerning implementation of the Biologics Price Competition and Innovation Act (BPCI Act), and was the lead Regulatory Counsel for multiple biosimilar approvals as well as approvals of new drugs, biological products, and generic drugs. He assisted CDER concerning a number of novel regulatory issues such as reference product exclusivity, patent disputes under the BPCI Act, and life-cycle management for non-biologic complex products
“The competition for experienced FDA counsel is fierce right now, and in Dan, we have one of the best,” said Kurt Weaver, leader of Womble Bond Dickinson’s Food, Beverage & Agriculture Team. “He understands first-hand how the FDA views drug safety and other pharmaceutical and biotech regulatory issues, and that insight will prove invaluable to our clients.”
Chris Douglas, leader of the firm’s Mass Torts Team, said, “The pharmaceutical and food industries are among the most highly regulated—and those regulations frequently result in conflict and litigation. Dan will help clients both avoid costly disputes and favorably resolve litigation when it does arise.”
“Helping clients navigate federal regulations is a key service of our D.C. office, and Daniel will be a great resource to food, drug and agriculture clients as they interact with the FDA,” said D.C. Office Managing Partner Pam Rothenberg.