FDA Chief Counsel Stacy Cline Amin Guided Agency Through COVID-19 EUAs And Guidances
Executive Summary
Amin leaves after two-year stint, but Trump administration chaos continues as HHS names a different replacement chief counsel than FDA did earlier in the day. James Lawrence is tapped to be FDA's top lawyer and will presumably help speed a number of regulatory changes at the agency.
Stacy Cline Amin stepped down as chief counsel of the US Food and Drug Administration on 11 January, ending a two-year tenure assisting the agency with a range of legal issues, including its response to the COVID-19 pandemic.
FDA Commissioner Stephen Hahn announced her departure in an email message to staff, noting that she played a critical role in nearly every aspect of the agency’s pandemic response efforts, including its record number of emergency use authorizations (EUAs), guidances, warning letters and enforcement actions.
Raza Briefly Named Acting Chief, Then Lawrence Tapped From HHS
Amin was named to the chief counsel position in September 2018. She moved to FDA from the White House, where she served as special assistant and senior associate counsel to the president. Prior to joining the White House in early 2017, she worked as chief counsel to the US Senate Health, Education, Labor and Pensions (HELP) Committee and as counsel to the House Energy and Commerce Committee. (Also see "From White House To White Oak: US FDA Taps Stacy Cline Amin For Chief Counsel Post" - Pink Sheet, 7 Sep, 2018.)
Stacy Cline Amin
Hahn’s morning email announcing her departure said that Mark Raza, who has been principal deputy chief counsel since 2011, would serve as acting chief counsel. But near the end of the day, HHS tweeted that James Lawrence, currently a deputy general counsel at HHS, will serve as FDA’s new chief counsel.
HHS Chief of Staff Brian Harrison said in a statement that Lawrence, “an experienced Food and Drug attorney, has been a trusted advisor on food and drug issues and instrumental in numerous recent actions which will positively impact the FDA’s public health mission.”
Lawrence joined the HHS Office of General Counsel as senior counsel in May. He was previously a partner at Michael Best & Friedrich LLP, and was a summer law clerk at FDA in 2011, according to his LinkedIn profile.
He will presumably be active in the typical last-minute rush of any outgoing administration to finalize regs and policies. (Also see "Some Long-Standing FDA Regs Face Mandatory Review Or Rescission Under New HHS Rule" - Pink Sheet, 8 Jan, 2021.)
For example, the same day the department announced Lawrence’s move, it noted, “As part of HHS's ongoing review of regulatory flexibilities enacted since COVID-19, we are making permanent FDA’s waiver of premarket review requirements on certain devices.”
HHS also announced a new policy on disclosure of drug review times that would require FDA to publish annual data on the total days elapsed between filing and approval of NDAs and ANDAs and “the total days in excess of 180-days.”
Today, the HHS Office of the General Counsel announced that James Lawrence, Deputy General Counsel, will serve as the new Chief Counsel at the FDA.
— HHS Office of Public Affairs (@SpoxHHS) January 11, 2021
Statement from HHS Chief of Staff Brian Harrison: pic.twitter.com/Ky6Qn9xIPs
Lawrence holds a noncareer appointment, so Raza, who joined the Office of Chief Counsel in 1990 and currently leads the OCC COVD-19 emergency response team, will presumably eventually become acting chief counsel again after the new administration takes office on 20 January.
Hahn said that Raza would work closely with Liz Dickinson, who will remain senior deputy chief counsel. Dickinson was named acting chief counsel in August 2011 and then took the role on a permanent basis in March 2012. (Also see "FDA Looks Inside For Chief Counsel, Taps Elizabeth Dickinson" - Pink Sheet, 5 Mar, 2012.)
Dickinson held the post until July 2017, when Rebecca “Becky” Wood took over. Wood left the following July.
A Legacy Of Emergency Use
Hahn’s email noted that Amin “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 said. Pfizer Inc./BioNTech SE’s COVID-19 vaccine was granted emergency use authorization on 11 December and Moderna, Inc.’s COVID-19 vaccine received EUA on 18 December.
The guidelines were critical as the agency faced public doubts about its independence given President Trump’s pressure on FDA leaders, and Hahn specifically, to rapidly review COVID-19 vaccines, at one point pushing for their availability prior to the election.
Hahn was also subject to strong criticism from former FDA commissioners and public health experts over the rollout of EUA for convalescent plasma and for overstating its benefit at a White House press briefing. (Also see "Plasma Authorization Raises Fears Of Politically-Influenced COVID-19 Vaccine Decisions, Compromised FDA" - Pink Sheet, 24 Aug, 2020.)
Amin defended the agency’s issuance of the EUAs for convalescent plasma and for chloroquine and hydroxychloroquine, the latter of which were later revoked, at the Food and Drug Law Institute’s virtual annual conference in October. She also praised Hahn for his fortitude and “moral strength” during the crisis. (Also see "FDA Chief Counsel Defends COVID-19 EUAs, Praises ‘Moral Strength’ Of Commissioner Hahn" - Pink Sheet, 8 Oct, 2020.)
From E-Cigarettes To Biologics Transition
Hahn also spoke highly of Amin.
“On a personal note, I will always be grateful to Stacy for her rigorous legal analyses and thoughtful advice and counsel that she has provided me during my tenure. It is Stacy’s combination of integrity and intelligence, however, that most characterizes her time as Chief Counsel at the agency,” Hahn stated. “It is this integrity and commitment to the law that allowed us to navigate some very difficult times.”
In addition to her COVID-19 work, Hahn noted that Amin was instrumental in advancing FDA’s policies around food safety, e-cigarettes and the foundational Tobacco Control Act rules, medical device safety and innovation, the biologics transition, human gene therapy and regenerative medicine, animal and plant biotech, compounding and opioids.
The biologics transition was the agency’s change in the regulation of insulins, human growth hormone and certain other proteins from drugs to biologics, as mandated under the Biologics Price Competition and Innovation Act. (Also see "Transition Day In The US: 96 Drugs Make The Move To Biologics Regulation" - Pink Sheet, 23 Mar, 2020.)
Cline cited this as one of top ten non-COVID-19 developments of the past year at the FDLI conference. (See sidebar for the top ten list).