Morrison & Foerster announces the arrival of Stacy Cline Amin as a partner in its Life Sciences + Healthcare practice. Ms. Amin will be based in Washington, D.C. and will co-lead the FDA Regulatory and Compliance practice. She joins Morrison & Foerster after a decade serving at the highest levels of government, where she most recently served in a dual role as Chief Counsel of the Food and Drug Administration and Deputy General Counsel of the U.S. Department of Health and Human Services.
In this senior advisory role, Ms. Amin led the FDA’s Office of the Chief Counsel and served as a trusted strategist and advisor to the FDA Commissioner, the Center Directors and other FDA leaders, and the Secretary of HHS. She played a critical role in nearly every aspect of the FDA’s COVID-19 pandemic response effort, including record numbers of emergency use authorizations, guidances, and enforcement actions, and served as one of the key leaders of the teams that issued the first two COVID-19 vaccine authorizations. During her two-and-a-half year tenure at the FDA, Ms. Amin navigated difficult regulatory issues and litigation challenges across the agency’s entire portfolio, including civil and criminal enforcement matters, human gene therapy and regenerative medicine, in vitro diagnostics, medical device safety and innovation, digital health, animal and plant biotech, and food safety modernization.
Prior to Ms. Amin’s role as FDA Chief Counsel, she served in the White House Counsel’s Office as a Senior Associate Counsel to the President, as the Chief Counsel of the Senate Health, Education, Labor & Pensions Committee, and as a Counsel on the House Energy & Commerce Committee. In these roles, she helped steer landmark legislation and regulatory change, with a focus on FDA, precision medicine, and digital health, and led high-stakes government investigations. Ms. Amin’s oversight efforts supported a number of legislative accomplishments, including passage of the Drug Quality and Security Act of 2013, the Cybersecurity Act of 2015, and the 21st Century Cures Act of 2016.
“Stacy brings exceptional healthcare and life sciences experience to the firm, having served in senior level positions in FDA, HHS, and the Executive and Legislative branches,” said Morrison & Foerster Chair Larren M. Nashelsky. “Her highly strategic regulatory and healthcare enforcement experience adds significant depth and breadth to our life sciences, healthcare, and FDA practices. Most recently, she played a key role in establishing the guidelines the FDA followed to ensure scientists could conduct independent, science-based reviews of the safety and efficacy of COVID-19 vaccines, and in managing the exceptionally complex legal issues in the face of this unprecedented global pandemic. Stacy will be an invaluable addition to our COVID-19 Task Force.”
Morrison & Foerster Global Litigation Department co-chair Bradley D. Wine added: “We are excited to have Stacy join our FDA Regulatory and Compliance practice, enhancing our ability to offer unparalleled FDA regulatory, investigations, litigation, and enforcement counseling to our clients, making Morrison & Foerster a best-in-class destination for clients navigating complex and mission-critical issues before the FDA.”
Michael Ward, Global Head of Morrison & Foerster’s Life Sciences + Healthcare practice, said: “Now could not be a better time for Stacy to join our dynamic, global Life Sciences + Healthcare practice to co-lead our FDA practice with Bethany Hills. Stacy brings an impressive breadth of expertise in life sciences and healthcare legal and regulatory issues that will serve our clients in major life sciences hubs around the world, such as San Francisco, Boston, San Diego, Tokyo, and Berlin.”
Ms. Amin’s arrival also highlights the continued expansion of the firm’s Washington, D.C. office and its litigation and regulatory capabilities. Since the start of 2021, the firm has added five former senior government officials as partners in Washington, D.C., including Ms. Amin, Brian Kidd, Brandon Van Grack, Alexander Okuliar, and David Shaw.
“After having spent a career serving across all branches of the U.S. Government, I’m excited to help clients in the life sciences and healthcare industries navigate their most difficult regulatory, compliance, and litigation challenges,” said Ms. Amin. “Morrison & Foerster’s unparalleled expertise at the intersection of health, life sciences, and technology and its commitment to exceptional client service is what attracted me to the firm. Together with my colleagues in the Life Sciences + Healthcare practice, I look forward to supporting our clients achieve their goals and improve the lives of people everywhere.”
Ms. Amin earned her B.A., summa cum laude, from George Washington University, and her J.D., cum laude, from Harvard Law School. Following law school, she clerked for the Hon. John R. Gibson in the U.S. Court of Appeals for the Eighth Circuit. Ms. Amin is admitted to the D.C. bar.