Updated: FDA’s top lawyer resigns
Editor's note: This article has been updated to reflect clarification from HHS about who will fill the role of chief counsel.The US Food and Drug Administration’s (FDA) top lawyer, Chief Counsel Stacy Cline Amin, resigned from the agency, effective Monday, according to an email to agency staff from FDA Commissioner Stephen Hahn.
However, the announcement as to who would succeed Cline Amin was met with confusion as the Department of Health and Human Services (HHS) separately announced that James Lawrence, deputy general counsel at HHS, would fill the role as chief counsel. Hahn’s email said that agency veteran Mark Raza, who has served as principal deputy chief counsel since 2011, would serve as Cline Amin’s replacement on an acting basis. A senior HHS official told Focus on Tuesday that Lawrence would fill the role of chief counsel until the presidential transition on 20 January.
Cline Amin, who was appointed to her position by President Donald Trump in 2018, also served as deputy general counsel for HHS and previously served as senior associate counsel to the president. Before her stint at the White House, Cline Amin was the chief counsel on the Senate Health, Education, Labor and Pensions Committee and counsel for the House Energy and Commerce Committee.
“During a time of unprecedented challenges at the FDA, Stacy has played a critical role in nearly every aspect of our COVID-19 pandemic response efforts, including record numbers of emergency use authorizations (EUAs), guidances, warning letters and enforcement actions. Most notably, she helped establish the guidelines that the FDA would follow to ensure our scientists could conduct independent, transparent, and science-based reviews of vaccine safety and efficacy. In addition, Stacy was a key leader to the teams responsible for the first two COVID-19 vaccine EUAs last year,” Hahn wrote.
Her departure comes less than two weeks before the presidential transition on 20 January and just days after Politico and the New York Times reported that White House Deputy Chief of Staff Chris Liddell issued a memo ordering political appointees to submit their resignations by the inauguration.