FDA pushes back on Trump administration attempt to rebrand ‘emergency authorization’

While Congress mandated earlier this year that Medicare cover the cost of administering a licensed vaccine, the requirement did not include drugs authorized under emergency-use designations. That’s raised the prospect that millions of people could be forced to pay out of pocket unless Congress were to adopt a quick fix.

HHS officials over the past month thought they found a solution, with Charrow arguing that the FDA should make clear that emergency authorization of a Covid-19 vaccine is equal to a “pre-licensure,” and should be covered by Medicare as a result, the officials said.

But Hahn firmly opposed the idea, amid concerns that failing to stick to the FDA’s technical language would erode the agency’s credibility and open it up to accusations that it’s allowing politics to influence its role in the Trump administration’s vaccine hunt.

“Hahn is hell bent against any modification of definitions, because it would be viewed as a politicization of science,” one senior administration official said, adding that while Hahn has so far rebuffed the proposal, some believe the White House could still get involved and demand changes.

Of particular concern, the official said, is that referring to a Covid-19 vaccine as having won a “pre-licensure” would be conflated with the shot being fully licensed by the FDA – a level of regulatory approval that signals the vaccine has met significantly higher standards for safety and effectiveness, and one the agency does not expect to grant to any vaccine candidates any time soon.

President Donald Trump has already spent months contradicting his own health officials involved in the complicated vaccine development process, claiming repeatedly that a viable vaccine is just around the corner and could be delivered faster than the end-of-year target agreed upon by the officials.

Suddenly changing how the FDA labels an eventual coronavirus vaccine could further muddle the situation, FDA officials worried, sparking confusion and deepening distrust of its work toward authorizing a vaccine.

In a statement, an FDA spokesperson pointed to “important substantive differences” between an emergency use authorization and the more stringent process required to seek full licensure of a vaccine.

“There is no such thing as ‘pre-licensure’ or ‘pre-approval’ under the laws FDA administers,” the spokesperson said.

An HHS spokesperson said that its Centers for Medicare and Medicaid Services is still exploring coverage options for vaccines authorized under an emergency use designation. And two administration officials downplayed the “pre-licensure” concept as an “academic discussion” about safety and effectiveness that never rose to the level of HHS Secretary Alex Azar.

But in talks with Hahn over the past several weeks, HHS officials presented the “pre-licensure” relabeling as the simplest and quickest way to close the Medicare coverage loophole, officials familiar with the conversations said.

The move would also prevent the Trump administration from having to rely on Congress to pass a legislative fix – a path that could get bogged down in gridlock on Capitol Hill.

“They’re trying to get creative – Congress is in disarray and they want a solution

NIH whistleblower quits, says administration ‘ignores scientific expertise’

Dr. Rick Bright says if we don’t figure out the coronavirus now we could have a challenging winter.

Dr. Rick Bright has officially quit his position at the National Institutes of Health.

Not only has the immunologist quit, he says it’s because the Trump administration didn’t listen to the scientific evidence available to stop the spread of the coronavirus, per The Guardian. He also says his plan to develop a testing infrastructure for the country was ignored.

Read More: Cynthia Bailey defends having 250 guests at wedding despite COVID-19

The doctor used to lead a team at the Biomedical Advanced Research and Development Authority, a department of the U.S. Health and Human Services. The agency, responsible for helping fight public health conditions such as bioterrorism attacks and pandemics, is currently working on a coronavirus vaccine.

Bright was transferred this spring and believes it’s retaliation for refusing to sign on to the decision to give New Yorkers hydroxychloroquine, the malaria drug Trump claimed as a COVID-19 remedy. He also claims senior NIH executives ignored his suggestion to provide healthcare workers with N95 respirator masks around the time the pandemic started.

Dr. Richard Bright, former director of the Biomedical Advanced Research and Development Authority, testifies during a House Energy and Commerce Subcommittee on Health hearing to discuss protecting scientific integrity in response to the coronavirus outbreak on Thursday, May 14, 2020. in Washington, DC. Warning that COVID-19 could make ‘2020 will be the darkest winter in modern history,’ Rick Bright, former director of the Biomedical Advanced Research and Development Authority has filed a federal whistleblower complaint alleging he was fired for opposing the use of a drug promoted by President Donald Trump as a potential coronavirus treatment. (Photo by Greg Nash-Pool/Getty Images)
Dr. Richard Bright, former director of the Biomedical Advanced Research and Development Authority, testifies during a House Energy and Commerce Subcommittee on Health hearing to discuss protecting scientific integrity in response to the coronavirus outbreak on Thursday, May 14, 2020. in Washington, DC. Warning that COVID-19 could make ‘2020 will be the darkest winter in modern history,’ Rick Bright, former director of the Biomedical Advanced Research and Development Authority has filed a federal whistleblower complaint alleging he was fired for opposing the use of a drug promoted by President Donald Trump as a potential coronavirus treatment. (Photo by Greg Nash-Pool/Getty Images)

He went public with the complaint he filed in May about his COVID-19 warnings being ignored.

“I was pressured to let politics and cronyism drive decisions over the opinions of the best scientists we have in government,” Bright said on a call per CNN, after filing the complaint.

When he testified before Congress in May, Bright said the US could undergo the darkest winter of modern history if it did not formulate a strategy to combat the virus.

Read More: Cuomo orders lockdown for parts of NYC after COVID-19 uptick

Dr. Bright’s attorneys Debra Katz and Lisa Banks said in a statement, “Dr. Bright was forced to leave his position at NIH because he can no longer sit idly by and work for an administration that ignores scientific expertise, overrules public health guidance, and disrespects career scientists, resulting in the sickness and death of hundreds of thousands of Americans.”

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New England Journal of Medicine editorial takes aim at Trump administration: “This election gives us the power to render judgment”

The New England Journal of Medicine made a rare political move Wednesday, publishing an editorial by dozens of U.S. editors who denounced the Trump administration’s handling of the coronavirus pandemic and said this election “gives us the power to render judgment.” 

The editorial, titled “Dying in a Leadership Vacuum,” does not explicitly endorse former Vice President Joe Biden, but the editors’ message is clear — the current leadership must change.

“Our current leaders have undercut trust in science and in government, causing damage that will certainly outlast them. Instead of relying on expertise, the administration has turned to uninformed ‘opinion leaders’ and charlatans who obscure the truth and facilitate the promulgation of outright lies,” the editorial says. 

“Anyone else who recklessly squandered lives and money in this way would be suffering legal consequences,” the editorial added. “Our leaders have largely claimed immunity for their actions. But this election gives us the power to render judgment.”

The editorial notes that, while some deaths in the U.S. were inevitable, tens of thousands could have been saved with a better response.

Meanwhile, President Trump is claiming personal victory over the virus, saying he feels great as he presumably continues to still be shedding the virus. The president said it was a “blessing from God” that he contracted COVID-19, so he can encourage greater access for the experimental drugs he used.

“I feel great. I feel like, perfect,” the president said in a four-minute video posted to Twitter. “I think this was a blessing from God, that I caught it. This was a blessing in disguise. I caught it, I heard about this drug, I said let me take it, it was my suggestion. I said, let me take it. And it was incredible the way it worked, incredible. And I think if I didn’t catch it, we’d be looking at that like a number of other drugs. But it really did a fantastic job. I want to get for you what I got. I’m going to make it free, you’re not going to pay for it.”

Meanwhile, “isolation carts” have been set up in the West Wing, where staff can pull personal protective equipment in order to interact with the president.

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Trump administration pressured CDC to play down risks of reopening schools: report

Top officials at the White House pressured leaders at the Centers for Disease Control and Prevention (CDC) to downplay the risk of the coronavirus to children as President TrumpDonald John TrumpCensus Bureau intends to wrap up count on Oct. 5 despite judge’s order Top House Republican calls for probe of source of NYT Trump tax documents New Yorkers report receiving ballots with wrong name, voter addresses MORE‘s administration pushed to reopen schools this fall, according to a new report. 

Citing documents and interviews with current and former government officials, The New York Times reported Tuesday the push included an effort to find data suggesting the pandemic was weakening and the coronavirus did not threaten children. 

A former member of Vice President Pence’s staff, who has since resigned, told the Times she was asked on more than one occasion by Marc Short, Pence’s chief of staff, to convince CDC leaders to find and present proof that the virus has little effect on children. 

The new Times report comes on the heels of a CDC study this week reporting teenagers are twice as likely to contract coronavirus as younger children. Separately, a study commissioned by the American Academy of Pediatrics and the Children’s Hospital Association found a dramatic rise in coronavirus cases among children in recent weeks. 

Earlier this summer, the CDC was forced to revise its guidance for school reopenings after Trump pushed back on them, saying they were too “expensive” for districts and “tough.” 

“The president said today we just don’t want the guidance to be too tough,” Pence said at a news conference in July. “That’s the reason why, next week, CDC is going to be issuing a new set of tools, five different documents that will be giving even more clarity on the guidance going forward.”

On Monday, NBC News reported CDC Director Robert Redfield was overheard on a phone call disparaging Scott Atlas, a new member of the White House coronavirus task force, whom he accused of feeding Trump bogus science about the pandemic. 

“Everything he says is false,” Redfield said of Atlas. 

Neither the White House nor the CDC immediately responded to a request for comment. 

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The Health 202: The Trump administration is urging schools to reopen with help from rapid coronavirus tests

President Trump announced yesterday from the White House Rose Garden that his administration is shipping 150 million rapid diagnostic tests to states. The money can be used to test people at K-12 schools, nursing homes, home health-care workers and historically Black colleges and universities, along with however else states want to use it. The administration had previously announced the deal to purchase the tests from Abbott Laboratories but provided more details about where the tests will be directed and how they can be used.

“In the coming weeks this will be more than double the number of tests already performed,” Trump said, noting that around 100 million coronavirus tests have been conducted in the United States since the start of the pandemic. 

“The support my administration is providing would allow every state on a regular basis to test every teacher who needs it,” he added.

Vice President Pence urged governors to send the tests to K-12 schools.

One hundred million of the tests are going to states, which will receive a supply based on their population size and can use the tests wherever governors see fit. 

“Given the extraordinary capacity we have in testing today, we expressed a hope to all the governors today they would particularly use them to open up America’s schools and keep them open,” Pence said.

The rapid antigen tests, which are the size of a credit card, don’t require samples to be shipped away to labs. Instead of taking days or weeks to process, they deliver results in 15 minutes after an individual swabs their nose and places the sample in a few drops of testing chemicals.

Health and Human Services Secretary Alex Azar:

Brett Giroir, assistant secretary for health at the Department of Health and Human Services, demonstrated the test before guests and media assembled in the Rose Garden. He said the United States now has the capability to process 3 million coronavirus tests a day, half of them rapid antigen tests.

Fears about young children rapidly spreading the virus haven’t yet materialized.

It’s just about a month into the academic year and cases are likely to rise throughout the world during the winter months but there have been some early encouraging signs that schools aren’t top breeding grounds for coronavirus infections.

“Public health experts have found little evidence that the virus is spreading inside [school] buildings, and the rates of infection are far below what is found in the surrounding communities,” Laura Meckler and Valerie Strauss reported. “This early evidence, experts say, suggests that opening schools may not be as risky as many have feared and could guide administrators as they chart the rest of what is already an unprecedented school year.”

Brown University researchers found low levels of infection among students and teachers, after working with school administrators to track coronavirus cases. They found just 0.23 percent of students had a confirmed or suspected case of the coronavirus over a two-week period in September. Among teachers, it was 0.49 percent.

Medicine Administration And Why It Is So Vital

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