Trump’s HHS claims absolute authority over the FDA, clearing path to a vaccine EUA
The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.
In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.
Azar’s signature is now required on all new rulemaking, which are typically signed by agency lawyers and bureaucrats.
“This was simply pushing a reset button,” claimed Azar’s top aide Brian Harrison to the Times. “This is good governance and should have no operational impact.”
It’s not immediately clear what the impact on this order will have on the agency’s day-to-day operations — especially on routine matters where it has long enjoyed political independence. An agency official not authorized to speak with the media told the Times they’re still “deciphering what Mr. Azar’s memo would mean for their work.”
The move comes just days after a group of high-profile FDA career servants — including Peter Marks, Jeff Shuren, and Janet Woodcock — wrote in a USA Today op-ed that “we will work with agency leadership to maintain FDA’s steadfast commitment to ensuring our decisions will continue to be guided by the best science.”
By taking authority that was once the clear domain of professional staff, the new memo is in line with the centralization of power across the federal government in the hands of Trump loyalists. And critics note that it blazes a path where the FDA could be side-stepped for an emergency use authorization on an early coronavirus vaccine. Eric Topol, director at the Scripps Research Institute, spelled out on Twitter a potential scenario with Pfizer’s candidate:
10. What if the FDA says NO, the data from 32 infections isn't enough? Clearly at that juncture there would be very limited data for the vaccine's safety.
The HHS can override that an issue the vaccine approval.
And we've already seen @HHSgov do that with FDA LDTs weeks ago.
— Eric Topol (@EricTopol) September 19, 2020
The power grab by Azar has evidently driven at least one established career servant to the exits. On Thursday, Politico reported that the FDA’s principal associate commissioner for policy, Lowell Schiller, left the agency last week. Schiller, a Scott Gottlieb hire, signed nearly every FDA notice on the federal register and played a central role in writing the FDA’s Covid-19 guidance. (Update: Politico now reports the departure was unrelated to the memo.)
After the Times published its story, an HHS spokesperson took to Twitter to again refute any suggestion that the FDA’s work would be slowed down but did not address concerns that the new memo could be used to overrule decisions by FDA staff. “The memo maligned in this story is a good governance, housekeeping action, which will not slow down the important work of the FDA or any HHS division,” the tweet said. Later on Sunday, the agency put out a FAQ-style response to news stories on the memo but did not provide the memo’s actual text.
The HHS memo is one of the most far-reaching actions in a decades-old quest by hard-right American conservatives to cripple the regulatory powers of professionals in executive-branch agencies. Despite being a congressionally delegated authority, President Trump and his political allies routinely frame the issue of as one of federal employees acting like “unaccountable bureaucrats.” Last year, while Trump was signing executive orders aimed at pairing back rulemaking across several agencies, his prepared remarks stated that “all too often guidance documents are a back door for regulators to effectively change the laws and vastly expand their scope and reach.”
Scott Gottlieb, a conservative who won wide praise across the political spectrum for his tenure as Trump’s first FDA commissioner, fought the encroachment on the agency’s rulemaking ability throughout his entire tenure. He used the powers as a cudgel against tobacco and vaping industries, and according to the Times report, even signed one of the last orders on it, hoping that his signature, rather than a lower-ranking staffer’s, would give his measure staying power on the books.
Azar, who has now asserted himself as the ultimate rule maker at the FDA, is Trump’s second HHS secretary, taking office in 2018. He was named president of the US division of Eli Lilly in 2012 and served on BIO’s board. He departed Lilly in 2017 when CEO David Ricks revamped the org chart.