Outgoing FDA chief: The agency fought 'substantial' pressure under Trump
The coronavirus pandemic revealed a “clash of cultures” between the White House pressing for faster progress on vaccines and treatments and the Food and Drug Administration’s efforts to stick to the science, outgoing Commissioner Stephen Hahn told POLITICO.
“I heard loud and clear from the White House — President Trump and others — that they wanted FDA to move faster,” Hahn said in an interview Tuesday, less than 24 hours before President-elect Joe Biden is scheduled to take office.
President Donald Trump never directly confronted Hahn about his repeated accusations that career scientists were holding back progress to hurt his political chances, but the White House did press for more rapid decisions related to Covid-19 vaccines and therapies, Hahn said. Besides calling to speed up the vaccine race, Trump and surrogates like trade adviser Peter Navarro repeatedly pushed FDA to authorize malaria pill hydroxychloroquine to treat the virus. The FDA did, and revoked the decision months later after the drug was proven ineffective.
“With time, particularly over mid- to last summer and then into fall, there was a substantial amount of pressure,” said Hahn, who took the helm at FDA a little over a year ago.
Crunch time
By early fall, coronavirus cases were swinging upward again while drug manufacturers worked their way through critical final trials of vaccine candidates. The Nov. 3 presidential election was also approaching, with Trump repeatedly promising that a vaccine would be available before the national vote.
When Hahn and FDA vaccine chief Peter Marks laid out beefed-up requirements for vaccine authorization in October, they virtually ended any chance of a vaccine before Election Day. By that time, public confidence had plummeted: Nearly two-thirds of Americans believed that FDA would speed decisions because of Trump's pressure, according to a September Kaiser Family Foundation poll.
Culture clash
Trump ran a very “results-oriented” administration that sometimes put a false dichotomy between speed and accuracy in decision-making, Hahn said. “So that was a little bit of a clash of cultures that affected many of the conversations.”
The clashes were not exclusive to the White House, according to the cancer doctor, a former top executive at MD Anderson. A string of last-minute policies from FDA’s parent, the Department of Health and Human Services, also left Hahn intermittently battling his boss, HHS Secretary Alex Azar.
“It’s fair to say there’s been ups and downs in the relationship,” said Hahn, who criticized Azar’s decision late Friday to establish term limits for dozens of health directors across agencies, including top FDA officials such as Marks and drug chief Janet Woodcock, set to be acting commissioner under Biden’s presidency.
Down to the wire
Minutes after Hahn spoke with POLITICO, the Agriculture Department released another policy backed by HHS that had been a bone of contention for officials at FDA, who argued it would strip the agency of key oversight on genetically modified animals.
Hahn later tweeted his consternation with the agreement, which he had refused to approve, and which HHS Assistant Secretary Brett Giroir ultimately signed. "FDA does not support the Memorandum of Understanding...[and] has no intention of abdicating our public health mandate," Hahn wrote. "We’ll continue to stay focused on executing our vital public health mission entrusted to us by the American people."
The slew of surprise policies has left Hahn calling for more FDA independence, though he hasn’t settled just yet on what form that should take. Seven former commissioners have called for the agency to be taken out of HHS' purview.
“There’s a lot of different models out there, but I think given what we’ve seen over the last year, particularly in the public health emergency, really bring this issue into the fore,” Hahn said. "Our rallying cry and our north star has always been science and data."
The outgoing FDA chief has not said where he will land after he leaves the agency.
