“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.
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.
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.