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FDA Chief Counsel Steps Down, Deputy to Become Acting Head (2)

Jan. 11, 2021, 5:12 PMUpdated: Jan. 11, 2021, 8:27 PM

The FDA’s top attorney, Stacy Cline Amin, will step down effective Monday, the agency’s head announced.

Cline Amin has served as chief counsel for the Food and Drug Administration since September 2018, coming to the agency after a year as senior associate counsel in the White House and after counsel positions in both the House and Senate committees with jurisdiction over the FDA’s work. Mark Raza, who has been the principal deputy chief counsel since 2011, will take over as acting chief counsel.

The announcement is unlikely related to the attack on the U.S. Capitol last week, as Cline Amin is a Trump administration appointee who was largely expected to resign before Jan. 20. She offered valedictory remarks as early as October.

“I am so honored that I had the opportunity to lead the amazing group of lawyers at FDA,” Cline Amin said at the Food and Drug Law Institute’s annual conference after acknowledging that meeting would likely be her final public appearance. “I’ve said it before, and I really mean it, that they are the most talented dedicated group of people that I have ever worked with.”

The FDA’s top legal appointment has fluctuated between career staff and political appointees. The incoming Biden administration could opt to bring in its own chief counsel or do what the Obama administration did in 2012, when it elevated career attorney Liz Dickinson from acting to permanent chief counsel.

“I do think the depoliticization and independence of FDA is likely to be a theme in the new Administration more generally, Dan Kracov, co-chair of Arnold & Porter’s life sciences and health-care regulatory practice and chairman of the FDLI’s board, said in an email.

Dickinson will remain in her role as senior deputy chief counsel, FDA Commissioner Steve Hahn said in a memo provided to Bloomberg Law.

“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,” Hahn said.

“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,” he said.

In her more than two-year tenure, Cline Amin oversaw the agency’s legal work on high-profile issues such as the agency’s authority to regulate e-cigarettes, a government shutdown, and the FDA’s response to the pandemic.

“When I accepted this job, I really thought I’d be working in relative obscurity out of an operating division in an agency in White Oak, Maryland,” Amin said at the conference, referring to the FDA headquarters about 10 miles from Washington. “But that has turned out not to be further from reality.”

Jennifer L. Bragg, an FDA attorney with Skadden, Arps, Slate, Meagher & Flom LLP and former chairwoman of FDLI’s board, told Bloomberg Law it was a pleasure to work with Cline Amin.

“Stacy should be congratulated for her hard work and stewardship of the Office of Chief Counsel,” Bragg said in an email.

(Updated with comment from Kracov in the sixth paragraph)

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloombergindustry.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Karl Hardy at khardy@bloomberglaw.com

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