Trump turns up pressure on FDA

President Trump is ratcheting up pressure on the Food and Drug Administration (FDA) to approve treatments and a vaccine for the coronavirus.

The agency on Sunday announced an emergency use authorization for convalescent plasma to treat COVID-19 patients, following extraordinary sustained attacks on the agency by Trump.

The president on Saturday accused the “deep state” at the FDA of slowing the development of treatments and vaccines before the November election.

“Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!” Trump tweeted.

Trump appeared to reiterate that belief during a Sunday news conference, telling reporters that he thought some health officials were allowing decisions to be “held up” for “political reasons.”

“I think there are people in the FDA and actually in your larger department that can see things being held up and wouldn’t mind so much. That’s my opinion, very strong opinion,” Trump said.

The campaign being waged against public health officials has alarmed outside experts, who fear politicizing the FDA could undermine confidence in the agency or worse, result in an unproven vaccine being pushed out to the public just before Election Day.

“The FDA was once again bullied into doing something that initially it wasn’t going to do,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Offit said Trump’s tweet attacking the FDA “was exactly what you most fear.”

“You get the sense he is trying to get a vaccine or vaccines approved before Nov. 3, which I think scares people. It should scare people. It makes you think that these vaccines may not be adequately tested,” Offit added.

The plasma announcement marked a turnaround for the agency, coming just days after officials at the National Institutes of Health (NIH) staged a rare intervention to stop the FDA from issuing the emergency use authorization.

Former FDA Commissioner Scott Gottlieb, who left the agency last spring, tweeted he was “confident in the science part” of the convalescent plasma authorization.

But Gottlieb took issue with the announcement itself.

“The way the public part was handled will erode precious public confidence. You earn public confidence in small drops, and you lose it in buckets,” Gottlieb said.

The authorization announcement also came on the eve of the Republican National Convention, a move that could give Trump some momentum heading into the four-day event.

“You saw convalescent plasma. You saw remdesivir. You’ll soon see vaccines pouring out years ahead of what they would have been under a ‘more traditional’ administration, where they would have taken years to come up with this stuff,” Trump said Monday.

He then thanked FDA Commissioner Stephen Hahn by name for deciding to issue the emergency use authorization.

The plasma authorization is the latest instance of public health officials seemingly making a decision related to COVID-19 after public pressure from the White House.

Many outside observers felt the FDA bowed to political pressure earlier this year when it issued an emergency use authorization for hydroxychloroquine, an anti-malaria drug that Trump, his allies and members of the administration continue to promote as a cure for COVID-19 despite insufficient medical evidence to support the claim.

In another instance, the White House reportedly pressured the Centers for Disease Control and Prevention to change its guidance on reopening schools in order to emphasize the importance of children returning to classrooms while downplaying potential risks.

Howard Koh, a public health expert at Harvard University’s T.H. Chan School of Public Health and a former assistant secretary for health in the Obama administration, said the wall between public health and politics is being threatened.

“It’s been extraordinary to see the president explicitly undermine his own agencies,” Koh said. “All that does is sow confusion for the public when the public expects the government to be working together.”

White House chief of staff Mark Meadows on Sunday confirmed that Trump has been applying pressure to the FDA but said it was being used as a positive motivation.

The president “had to make sure that they felt the heat,” Meadows said during an interview on ABC’s “This Week.”

“If they don’t see the light, they need to feel the heat because the American people are suffering. This president knows it, and he’s going to put it on wherever — the FDA or NIH or anybody else — to make sure that we deliver on behalf of the American people,” Meadows said.

Meanwhile, Hahn has taken pains to show the FDA is completely independent from political persuasion, especially when it comes to a potential coronavirus vaccine, and will not be cutting any corners.

In recent weeks, Hahn has penned op-eds in The Washington Post and the Journal of the American Medical Association promising he would listen to an outside panel of experts and would not authorize any vaccine unless it was safe and effective.

But it’s not clear whether he will be successful in convincing an increasingly skeptical public to take a vaccine when it becomes available.

“Perception is reality in a crisis,” said Koh. “The efforts of the agencies and all the health leaders right now has got to be to engender trust and confidence from the medical community and the public alike. Otherwise, these [interventions] are not going to be effective.”