Nationally Recognized FDA Life Sciences Lawyer To Join Skadden DC

Skadden is pleased to announce that William (Bill) McConagha has joined the firm’s Health Care Litigation and Enforcement practice as a partner in the Washington, D.C. office. A 17-year veteran of the Food and Drug Administration (FDA) and, most recently, a partner in the food and drug practice at another major global law firm, Mr. McConagha advises pharmaceutical, medical device, biotech, food and tobacco companies on government and internal investigations, FDA regulatory requirements, litigation, FDA enforcement issues and corporate transactions. His practice focuses on a broad range of FDA requirements as well as pharmaceutical and device quality issues, with a particular emphasis on current good manufacturing practice-related compliance matters. Mr. McConagha’s addition comes on the heels of another former FDA lawyer and regulator, Karen Corallo, joining the practice in March 2019.

“With FDA enforcement increasing its focus on product quality, data integrity and quality of the supply chain, Bill’s extensive experience guiding companies through complex FDA compliance issues, coupled with his years of government service, positions him well to advise clients on enterprise-critical litigation as well as their strategically important FDA work,” said Jennifer Bragg, a partner in Skadden’s Washington, D.C. office and a former associate chief counsel at the FDA. Ms. Bragg also serves as chair of the board of directors of the Food and Drug Law Institute.

Prior to his transition to private practice in 2012, Mr. McConagha served in a variety of capacities at the FDA, including as assistant commissioner; a senior attorney in the Office of Chief Counsel (OCC); and a health policy adviser to the Senate Committee on Health, Education, Labor and Pensions (HELP). As assistant commissioner, Mr. McConagha managed the FDA’s advisory committee process, and at HELP he played a key role in drafting and negotiating the Food Safety Modernization Act of 2011 and the FDA Safety and Innovation Act of 2012. During his tenure in the FDA’s Office of Chief Counsel, Mr. McConagha handled enforcement and defensive litigation; prosecuted criminal cases as a special assistant U.S. attorney; advised the FDA’s Office of Criminal Investigations; and provided regulatory counsel on a range of issues to the Center for Drug Evaluation and Research, Office of Regulatory Affairs, Office of Combination Products, Office of Policy and four FDA commissioners.

“The quality and breadth of Skadden’s health care capabilities — litigation, regulatory, enforcement and transactional — are superb,” said Mr. McConagha. “I look forward to working alongside such highly skilled attorneys and utilizing the firm’s unparalleled global platform in servicing clients.”

In addition to being recognized in legal directories for his FDA and life sciences work in private practice, Mr. McConagha received numerous awards during his tenure at the FDA, such as the Secretary’s Award for Distinguished Service, Department of Health and Human Services; Excellence in Legal Services, Office of the General Counsel, Department of Health and Human Services; and Director’s Award for Outstanding Service, FDA’s Office of Criminal Investigations.

A graduate of Carleton College (magna cum laude), Mr. McConagha earned his J.D. from Georgetown University Law Center (cum laude). He has also been an adjunct professor at American University’s Washington College of Law.