Chief Counsel, U.S. Food and Drug Administration; Deputy General Counsel, Department of Health and Human Services
Stacy Cline Amin serves as Chief Counsel of the Food and Drug Administration and Deputy General Counsel of the Department of Health and Human Services. Stacy serves as the senior legal advisor to the Commissioner, FDA leadership, the HHS General Counsel and Departmental leadership on FDA regulatory and litigation matters. Stacy leads an office of 165 lawyers and support staff that provide counseling and litigation support to the agency.
Stacy previously served as Special Assistant to the President and Senior Associate Counsel to the President, serving as the senior legal advisor on matters relating to the Department of Health and Human Services. In that role, Stacy advised on critical matters arising under the Food Drug and Cosmetic Act, helped lead the Administration's efforts to combat the opioid crisis, led multi-agency teams in the evaluation of high profile administrative actions, and successfully coordinated litigation strategy with the Department of Justice.
Prior to joining the White House, Stacy served as the Chief Counsel of the Senate Health, Education, Labor and Pensions Committee and as a Counsel for the House Energy & Commerce Committee. In Congress, Stacy frequently advised on Food Drug and Cosmetic Act issues and led bipartisan and bicameral investigations to promote patient safety and global public health. These efforts supported a number of legislative accomplishments, including passage of the Drug Quality and Security Act of 2013 and the 21st Century Cures Act of 2016.
Earlier in her career, she served as an Associate at Sullivan & Cromwell LLP and as a law clerk to the Hon. John R. Gibson on the U.S. Court of Appeals for the Eighth Circuit. She graduated cum laude from Harvard Law School and summa cum laude from The George Washington University.
Attorney General, Alaska
Stephen J. Cox serves as the 28th Attorney General of the State of Alaska, where he oversees the state’s legal affairs and serves as the chief prosecutor with oversight of all district attorneys, general counsel to the Governor and executive branch, and represents the State in all civil and criminal cases in federal and state court. He brings to the role a proven record of public service at the highest levels of the U.S. Department of Justice, combined with deep experience in Alaska’s private sector and community life.
Before his appointment, he was Senior Vice President, Chief Legal and Strategy Officer of Bristol Bay Industrial—an investment platform of the Bristol Bay Native Corporation—acting as the chief legal officer for the industrial services portfolio on behalf of the Alaska Native shareholders in the Bristol Bay region. In that role, he led legal, compliance, and strategic planning for major energy, infrastructure, and utility projects across the State and in the Lower 48.
Earlier in his career, beginning in 2011, Cox served as in-house counsel for Apache Corporation, where he was the principal attorney for Apache Alaska and focused on new ventures and exploratory work in Cook Inlet, including seismic initiatives and ongoing regulatory coordination with state agencies.
Cox is deeply rooted in Anchorage’s community and faith life. He and his family attend Holy Family Old Cathedral in downtown Anchorage and support Mission Alaska, the Dominican friars’ outreach ministry under the Western Dominican Province. He was the founding board president and chairman of a new classical school in South Anchorage.
On the national stage, Cox held senior leadership roles in the U.S. Department of Justice under the Trump Administration. As Deputy Associate Attorney General, he co-chaired the DOJ’s Regulatory Reform Task Force and the Working Group on Corporate Enforcement and Accountability, and helped implement landmark policies aimed at curbing regulatory overreach and aligning enforcement with fairness and oversight. Later, as U.S. Attorney for the Eastern District of Texas, he oversaw prosecutions and civil litigation spanning 43 counties, prioritizing healthcare fraud, elder fraud, and violent crime while ensuring enforcement remained transparent and fair.
Earlier in his career, Cox practiced complex litigation at a major international law firm, served as counselor to the Director of U.S. Immigration and Customs Enforcement, and helped lead the William H. Webster Commission, which reviewed FBI counterterrorism intelligence and operations following the Fort Hood tragedy.
He began his legal career with a clerkship for Judge J. L. Edmondson of the U.S. Court of Appeals for the Eleventh Circuit. Cox earned a B.S. in Computer Science from Texas A&M University and a J.D., summa cum laude, from the University of Houston Law Center. He and his wife, Cristina, are raising their three children in Anchorage, and have made Alaska their home.
Operating Advisor, Clayton, Dubilier & Rice
Anand Shah, MD, is an Operating Advisor at private equity firm Clayton, Dubilier & Rice. Dr. Shah develops and identifies potential investment opportunities in the healthcare industry with a focus on health care services, including the provider, payer, and HCIT sectors. He also serves as an advisor to the firm’s portfolio companies.
A nationally recognized physician leader and health policy expert, Dr. Shah has extensive healthcare experience in the senior-most levels of the U.S. government, private sector, and as a physician. He was previously the Deputy Commissioner for Medical and Scientific Affairs at the U.S. Food and Drug Administration (FDA). Dr. Shah led consensus policy development for fit-for-purpose programs including Advanced Manufacturing, the Coronavirus Treatment Acceleration Program, Covid vaccine development, digital health, consumer protection, and decentralized clinical trials. During the Covid pandemic, he led FDA’s policy development for preparedness and recovery efforts. Dr. Shah represented FDA with top-level policy makers of the White House and Cabinet, Governors and local governments, and regularly led briefings with Congressional leadership.
He previously served in two senior leadership roles at the Centers for Medicare & Medicaid Services (CMS). As Senior Medical Advisor, he was the primary counselor for agency-wide policy related to medical and scientific innovation. Dr. Shah established consensus on several critical policy initiatives including aligning payment and prevention to increase Medicare beneficiaries’ access to novel antimicrobials, expanding patients’ access to cell and gene therapies, and streamlining Medicare access to breakthrough technologies. As the Chief Medical Officer of the Center for Medicare & Medicaid Innovation (CMMI), Dr. Shah led the clinical design of novel value-based payment and service delivery models including those for primary and specialty care.
Dr. Shah specializes in the early detection, surveillance, and treatment of prostate cancer, and previously developed and led a survivorship clinic for patients on cancer clinical trials at the National Institutes of Health. His scientific track record includes publications in the New England Journal of Medicine, JAMA, Health Affairs, Cancer, and Nature Reviews Drug Discovery. Dr. Shah is an Adjunct Professor with the Department of Medical Ethics and Health Policy and an Adjunct Senior Fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania.
Dr. Shah was chief resident during his radiation oncology residency at Columbia University. He concurrently earned his MD from the University of Pennsylvania and an MPH in health care management and policy from the Harvard School of Public Health. Dr. Shah graduated with honors from Duke University with a degree in economics. He also served as a Canada-U.S. Fulbright Scholar.
Capital Conversations: COVID-19 and FDA; Medical, Legal, and Regulatory Perspectives
Stacy Cline Amin, Stephen Cox, Anand Shah
During the COVID-19 pandemic, the United States Food and Drug Administration (FDA) has sought to...