The U.S. Food and Drug Administration is being bullied by the White House and pressured to allow emergency use of products to treat COVID-19 without the data to back up those actions, an independent expert adviser to the agency said.

Prime examples of that pressure are the FDA's emergency use authorizations, or EUAs, for hydroxychloroquine and a related drug chloroquine and convalescent plasma, said Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia.

The EUAs were granted for those products before there were adequate data to show they worked in treating COVID-19, Offit said Aug. 24 on CNN's "The Lead."

Offit is a member of the FDA's Vaccines and Related Biological Products Advisory Committee.

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The FDA has scheduled a tentative Oct. 22 meeting for the panel to potentially vet experimental COVID-19 vaccines, despite the agency not yet having a clear idea if it will have any applications or phase 3 data by that date for the expert advisers to review.

Offit said he was concerned the FDA would be forced by President Donald Trump to rush a COVID-19 vaccine to the market under an EUA before the product was thoroughly vetted.

Trump and members of his administration have repeatedly talked about having a COVID-19 vaccine authorized for emergency use before the end of 2020 — potentially ahead of the Nov. 3 election.

The Trump administration "hasn't been attentive to good science," Offit said.

"You want robust, statistically solid efficacy data and if we don't have that and we bring a vaccine out too early, I think we could scare an already skittish American public," he said. "We can't mess this up."

Lacking data

The FDA revoked the EUAs for hydroxychloroquine and chloroquine in mid-June a little over two months after they were issued because data showed the drugs failed to work in COVID-19 and could harm patients, Offit noted.

The convalescent plasma EUA was granted on Aug. 23 — an action that came after Trump accused FDA scientists of slow-walking the decision to harm him politically.

But Offit said there was not adequate data to show that the plasma therapy worked in patients with COVID-19.

"The FDA's job is to make sure that they would not approve a product until it's been shown to be safe and effective and this had not clearly been shown to be effective, and everybody agreed to that a few days ago," Offit said Aug 24 on CNN. "Nonetheless, last night, there was a change of heart by the FDA without any new data. So, one can only conclude that there had to be some pressure on the FDA to do that. And looking at Donald Trump's tweets, you can only conclude that."

Trump tweeted Aug. 22 that the FDA was a "deep state" agency where scientists were "hoping to delay" approvals of drugs and vaccines until after the election.

White House Chief of Staff Mark Meadows said Trump's tweet was intended to put pressure on FDA's scientists.

"If they don't see the light, they need to feel the heat," Meadows said Aug. 23 on ABC's "This Week."

Offit said the EUA concerns him that "it sets yet another precedent to make you worried about the fact that the administration is willing to bully its science-based agencies."

Confusion

In announcing the EUA, FDA Commissioner Stephen Hahn claimed regulators had observed data that showed a "35% improvement in survival" in COVID-19 patients who received convalescent plasma.

He said that out of 100 people who were sick with COVID-19, "35 would have been saved because of administration of plasma."

But many in the scientific community were quick to point out there are no data from randomized clinical trials that show convalescent plasma is successful in treating COVID-19 and broadly criticized Hahn's claims.

The FDA commissioner later said that he had confused relative risk and absolute risk when reviewing data from an ongoing expanded access program run by the Mayo Clinic.

But Hahn waited more than 24 hours to acknowledge his mistake — an admission that came in a series of late-night tweets Aug. 24.

"I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified," Hahn tweeted. "What I should have said better is that the data show a relative risk reduction not an absolute risk reduction."

But the FDA did not issue a correction or remove erroneous information from its website or from Twitter that repeated Hahn's mix-up.

Political motivations

In an Aug. 24 op-ed in The Washington Post, Jeremy Faust, an emergency physician at Brigham and Women's Hospital and an instructor at Harvard Medical School, said the FDA had cherry-picked the data it used to base the plasma therapy EUA. He said the FDA had subverted science and had "caved" to Trump's demands.

Rep. Frank Pallone, D-N.J., chairman of the House Energy and Commerce Committee, and two subcommittee leaders also raised concerns the FDA was being politically pressured.

In an Aug. 24 letter, they called on Hahn to describe what safeguards he had in place to protect against political interference or the appearance of such activity.

Hahn pushed back at the idea the FDA was being pressured by the White House.

But on Aug. 24, the White House handpicked a senior adviser for Hahn, hiring Heartland Institute's David Gortler. It is unusual for the White House to make an FDA appointment.

The Heartland Institute has frequently targeted the FDA, calling it a "dangerous roadblock for new products entering the marketplace."