Clash Over FDA’s Top Lawyer Appointees Causes Further Discord Between Agency and HHS
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The U.S. Food and Drug Administration (FDA) is experiencing abrupt and noticeable personnel changes as it continues to clash with the Health and Human Services (HHS), the department that oversees the agency and its operations.
As reported in POLITCO, the FDA on Monday went through three different top lawyer nominees after the agency’s top lawyer resigned prior to the inauguration of President-elect Joe Biden. Stacy Cline Amin stepped down as chief counsel, with the FDA announcing Mark Raza as the acting replacement for the position.
But HHS had other ideas, instead announcing in a tweet on Monday that James Lawrence would serve as the chief counsel. Lawrence moved into the department’s legal team in May of last year. According to two officials, White House Chief of Staff Mark Meadows supported the decision to appoint Lawrence as the agency’s top lawyer.
In a statement made by HHS chief of staff Brian Harrison and published in POLITICO, Lawrence "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.”
The HHS claims the FDA made too quick of a decision on naming a career civil servant for chief counsel. Amin joined the FDA in 2018 after serving in the White House for 18 months. Amin clashed with lawyers at the HHS, and some officials have suggested the departure of Amin was planned prior to Monday’s announcement.
These last-minute decisions from the HHS have reportedly annoyed health officials at the FDA. A few officials at the agency are preparing for HHS to rush in additional policy changes before President Trump leaves office, POLITCO reported on Monday. These changes in deregulatory policies, which appear to be organized by Lawrence, may “roll back” FDA’s reviews that the agency and its allies have previously opposed.
"I've been disappointed to see HHS infringing on FDA's public health prerogatives in the closing days of the administration," according to a tweet made by former Trump FDA commissioner Scott Gottlieb following the announcement of the new policies. "The way they're pursuing these unilateral actions will have long term consequences at a time when FDA's stature is critical to seeing us through this crisis."
Current FDA Commissioner Stephen Hahn has allegedly been dueling with HHS Secretary Alex Azar, primarily in regard to the speed at which COVID-19 vaccines have been reviewed, among other policy actions. Azar had reportedly discussed firing Trump-appointed Hahn prior to November’s presidential election. Previous reports in December 2020 noted that the White House was prepared to allegedly demand the resignation of Hahn if the FDA did not grant Emergency Use Authorization to the Pfizer and BioNTech COVID-19 vaccine.
Azar was confirmed as the HHS Secretary in early 2018. In September 2020, Azar assumed final authority over rules regarding food, medical devices and new treatments, with this authority encompassing COVID-19 vaccines. Changes made to how the agency handles vaccine approvals mandated that Azar would formally sign off on each new regulation. There were some concerns that this would usher in an approved COVID-19 vaccine before it was safe to use, but Gottlieb quickly disputed this fear when he appeared in CBS’ Face the Nation.
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