WASHINGTON—Julie Dohm has joined Covington's Food, Drug, and Device practice in Washington.
Dr. Dohm focuses on regulatory matters for pharmaceutical and biotechnology clients. She has handled cases on a wide range of regulatory topics such as preemption, drug promotion, drug shortage, import-export, exclusivity, and generic drug approval standards.
Prior to joining the firm, she served as the Senior Science Advisor for Compounding, Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). Dr. Dohm was responsible for the overall leadership of the FDA’s compounding initiative, including implementing legislation, overseeing inspections, preparing regulatory and enforcement actions, developing policy, and conducting stakeholder outreach.
Before assuming her compounding role, Dr. Dohm was in FDA’s Office of Chief Counsel. As a civil litigator, she represented the FDA with the Department of Justice in affirmative, defensive, and third-party litigations at the trial and appellate levels, including at the U.S. Supreme Court. She also served as a drugs counselor, advising CDER on legal issues relating to generic drugs and biosimilars.
"Julie is a rising star in the drug regulatory field and adds important strength to the firm's next generation of senior drug regulatory lawyers," said Denise Esposito, co-chair of Covington’s Food, Drug, and Device group. "She brings strong FDA experience, grounding in a range of important drug regulatory issue areas, and a valuable scientific background that is of critical importance to our pharmaceutical industry practice."
"I am excited to join Covington and its life sciences practice, which is regarded as one of the most preeminent in the life sciences industry," said Dr. Dohm. "I look forward to applying my expertise to a wide range of regulatory, transactional, investigation, and litigation matters."
Dr. Dohm received her B.S. in biochemistry from the University of Chicago, her Ph.D. in biology from Johns Hopkins University, and her J.D. from the University of Pennsylvania Law School. After law school, she served as a law clerk to the Hon. Alvin A. Schall of the U.S. Court of Appeals, Federal Circuit, and Hon. Roger W. Titus, U.S. District Court, District of Maryland.
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