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Trump's attacks on FDA criticized; Supreme Court health law fight after election


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Trump's attacks on FDA criticized; Supreme Court health law fight after election

Lawmakers on Capitol Hill, former government officials, drug industry representatives and top scientists condemned President Donald Trump's weekend attacks on the U.S. Food and Drug Administration, saying his attempts to undermine the agency will harm public health efforts in the midst of the COVID-19 pandemic.

Trump's Aug. 22 tweet calling the FDA a "deep state" agency where scientists were "hoping to delay" approvals of drugs and vaccines until after the Nov. 3 U.S. election was "very dangerous," said House Speaker Nancy Pelosi, D-Calif.

"Even for him, it went beyond the pale in terms of how he would jeopardize the health and well‑being of the American people and accuse the FDA of politics when he is the one who has tried to inject himself in the scientific decisions of the Food and Drug Administration," Pelosi told reporters Aug. 22.

White House Chief of Staff Mark Meadows confirmed Trump had intended to put pressure on the FDA with his tweet.

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

He made similar remarks on "Fox News Sunday."

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Meadows said the White House has "looked at a number of people that are not being as diligent as they should be" in moving quickly on drugs and vaccines for COVID-19.

Meadows alleged, without evidence, that an effort to slow down COVID-19 vaccines and treatments was coming not just from scientists at the FDA but also from the U.S. National Institutes of Health and other federal agencies — a claim Trump repeated during an Aug. 23 news conference.

Employees who have disagreed with Trump have been "relocated," Meadows acknowledged, possibly referring to whistleblower Rick Bright, who was ousted in April as director of the Biomedical Advanced Research and Development Authority and moved to a lower-level job at the NIH — an abrupt transfer he is fighting.

"To threaten FDA and NIH officials with relocation if they fail to 'see the light' is dangerous," said Rep. Rosa DeLauro, D-Conn.

Hours after Meadows' remarks on ABC and Fox, Trump revealed the FDA had granted emergency use authorization, or EUA, for convalescent plasma to treat COVID-19 patients — a decision many in the scientific community viewed as controversial.

'Esprit de corps'

Venture capitalist Scott Gottlieb, Trump's first FDA commissioner, said he rejected the idea the agency's scientists were attempting to slow-walk or speed up their work on COVID-19 drugs and vaccines for political reasons.

The FDA's decisions are guided by a "foundational truth," Gottlieb said Aug. 23 on CBS' "Face the Nation." "It's a part of the esprit de corps of the staff of that agency."

"One of the great things about FDA is that decisions are made by full-time civil servants without conflicts," Robert Califf, who served as FDA commissioner at the end of the Obama administration, tweeted Aug. 22. "They work for the public health."

"Everyone is eager to deliver the treatments we need to eradicate this pandemic as quickly as possible, but we can only move as fast as the science allows us," Rich Masters, spokesman for the Biotechnology Innovation Organization, told S&P Global Market Intelligence. "We are confident everyone is moving as fast as possible to ensure any vaccine or new therapy is both safe and effective for patients to use."

The Pharmaceutical Research and Manufacturers of America had no comment.

'Incalculable' damage

SNL ImageHolly Fernandez Lynch, assistant professor of medical ethics at the University of Pennsylvania
Source: University of Pennsylvania

The damage from Trump's attacks on the FDA is "incalculable" in terms of making the agency "even more political than it has to be and causing the public to question whether the agency can be trusted," said Holly Fernandez Lynch, assistant professor of medical ethics at the University of Pennsylvania.

Patti Zettler, associate professor of law at The Ohio State University, said Trump was "way off base," noting COVID-19 product development "has, in reality, been extraordinarily fast so far."

"I can't underscore enough how worrying this kind of political pressure on FDA is," Zettler told S&P Global Market Intelligence.

Zettler was among over 50 legal experts from a number of academic institutions who urged Congress in an Aug. 18 report to ban the FDA from using an EUA for COVID-19 vaccines.

While some market watchers have speculated Trump would try to press the FDA to grant an EUA for experimental COVID-19 vaccines from Moderna Inc. or Pfizer Inc. before the Nov. 3 election, the Financial Times reported Aug. 23 the administration was eyeing using the action for a shot being developed by AstraZeneca PLC and the University of Oxford — a claim the administration denied.

Supreme Court November arguments

Meanwhile, the U.S. Supreme Court will not hear oral arguments in a Republican lawsuit challenging the constitutionality of the Affordable Care Act until a week after the election.

The case will go before the justices on Nov. 10, according to a notice issued by the court Aug. 19.

At stake are a number of programs and protections created by the ACA — former President Barack Obama's signature legislative achievement.

Most notably, Americans with preexisting medical conditions could be put at risk of losing their insurance coverage, since those safeguards against discrimination were put into place under the ACA.

Trump has vowed for four years to dismantle the law.