Ex-FDA employees express worries to Congress over politicization of vaccines

Experts and former Food and Drug Administration officials say they worry President Trump is undermining public confidence in the COVID-19 vaccine approval process, potentially leading people to reject the vaccine when one is available. 

The experts, appearing before a Congressional panel Tuesday, said they still have faith in the government’s career officials and scientists responsible for determining whether a potential COVID-19 vaccine is safe and effective, but that Trump and his political appointees are making it harder to gain public trust. 

“This is a very robust process that’s hard for any political influence to disrupt,” Mark McClellan, a former FDA commissioner under former President George W. Bush, told the House Oversight and Investigations Subcommittee on Tuesday. “What we are more concerned about is the impact of political influence on confidence.” 

Polls show Americans are increasingly skeptical about taking a COVID-19 vaccine, citing worries about political interference. Trump has attacked the FDA’s plan to issue tougher standards on emergency vaccine approval as a “political move.” The FDA has approved the emergency use of potential COVID-19 treatments before evidence showed they were effective. 

These actions “are eroding the public’s confidence,” McClellan and six other former FDA commissioners wrote in a Washington Post op-ed published Tuesday.

“A safe and effective vaccine will not be enough; people will also have to choose to take it,” the commissioners wrote. “This depends on widespread confidence that the vaccine approval was based on sound science and not politics.”

The commissioners went on to say they still have confidence in the integrity and “high-quality scientific work” of FDA career staff, who will decide whether a vaccine is approved using strict standards for evidence. 

“But the perception of political influence matters. With more than 750 Americans on average dying a day from COVID-19, the FDA must be supported to play its unique and essential role,” they wrote. 

Drug manufacturers have also issued a rare joint pledge that asks the FDA to only approve a vaccine that rigorous trials show is safe and effective. 

Other experts told Congress on Wednesday it should be scientists at the FDA and Centers for Disease Control and Prevention (CDC) who are out front talking about potential COVID-19 vaccines, especially when it comes to the timeline.

Trump has repeatedly said a vaccine will be ready in weeks, maybe even before Election Day, although experts say that is highly unlikely. 

“I think all political leaders need to stop talking about things like timelines. Politicians don’t know what the scientific timeline is and unfortunately, the political appointees have not been very helpful either,” said Ashish Jha, dean of the School of Public Health at Brown University. 

“If the career scientists at the FDA or the ones at the CDC get to do their job, and we hear from them directly, that they believe that the process has had high integrity, I think that would be enormously helpful and would go a long way to offering assurance to the American people that this is a process with integrity. … We need to make sure that their words and voices carry the day and not those of political leaders,” he said.

Paul Offit, who serves on the FDA vaccine advisory committee, which reviews and evaluates data for safety and effectiveness of vaccine candidates, told the panel politics does not enter into the committee’s recommendations. He appeared frustrated as he recounted the public’s drop of trust in the FDA.

“I don’t understand why we’re having this meeting, to be honest with you,” he said.

“We shouldn’t need this meeting because we should trust the FDA. We don’t trust the FDA largely because of what has happened with the administration pushing the FDA to do things that shouldn’t have been doing. That’s why people are upset about this.”