WASHINGTON, D.C.—Womble Bond Dickinson attorney Dan Orr was quoted in The Pink Sheet article “US Biosimilars: FDA Seeks To Build On Record Number Of Approvals, But Shutdown May Blunt Progress” (subscription required) about the impact of the partial government shutdown on the U.S. Food and Drug Administration.       

The shutdown “will delay everything FDA does significantly,” Dan said. “Part of that is there's tremendous confusion among the FDA staff as to what they can work on and what they can’t work on during the shutdown.”  Dan also explained that the shutdown consumes managerial attention and resources from FDA’s policy priorities, and would make it difficult for the agency to meet a March 23, 2020, statutory deadline to publish certain biologics regulations in final form.

Dan Orr is a Partner in the Washington, D.C. office of Womble Bond Dickinson.  He advises clients concerning regulatory and patent issues in the pharmaceutical, biotech, and medical device sectors.  Before joining WBD in January 2018, Dan was a Regulatory Counsel in FDA’s Center for Drug Evaluation & Research where he solved regulatory problems in a portfolio of drugs and biologics with combined annual sales of more than $37 billion.  

The Pink Sheet is a leading trade publication that covers policy and regulatory issues for the global biopharma industry.