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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

Supreme Court puts on hold Trump administration request to reimpose medication abortion restrictions

“While COVID-19 has provided the ground for restrictions on First Amendment rights, the District Court saw the pandemic as a ground for expanding the abortion right recognized in Roe v. Wade,” wrote Justice Samuel A. Alito Jr., who was joined by Justice Clarence Thomas.

Alito said the court has “stood by” while officials imposed restrictions on religious activities and “drastically limited speech, banning or restricting public speeches, lectures, meetings, and rallies.”

The court’s action in this case cannot be squared with that, Alito wrote.

Chuang ruled in July that requiring an in-person visit to obtain the medications needed to induce abortion was unduly burdensome. There is no requirement that a woman take the medication in a clinic setting, and most take the pills that end a pregnancy in its early stages at home.

At the request of abortion providers and the American College of Obstetricians and Gynecologists, Chuang imposed a nationwide injunction against the Food and Drug Administration directive.

After a panel of the U.S. Court of Appeals for the 4th Circuit refused to put Chuang’s order on hold, acting solicitor general Jeffrey B. Wall went to the Supreme Court.

Instead of agreeing with the government’s petition, the court’s order issued Thursday night directed Chuang to “promptly consider a motion by the government to dissolve, modify, or stay the injunction, including on the ground that relevant circumstances have changed.”

The case took on added significance because it was the first abortion order issued after the death of Justice Ruth Bader Ginsburg, the court’s most outspoken advocate for abortion rights.

The unsigned order and compromise decision may indicate the court was deadlocked, although only Thomas and Alito declared their views.

Wall told the court that, even in the pandemic, the government had not changed its views on how the drugs should be dispensed.

“The FDA has made, and continuously adhered to, the judgment that these requirements mitigate serious health risks associated with the drug, which can increase if the patient delays taking the drug or fails to receive proper counseling about possible complications,” Wall wrote.

Abortion providers told the court that there was no reason an in-office visit was necessary.

The rules “force patients seeking early abortion care and their health care providers to unnecessarily risk exposure to a life-threatening disease by mandating that patients travel to a health center for the sole purpose of picking up a pill and signing a form,” Julia H. Kaye of the American Civil Liberties Union wrote in a brief to the court.

Medication abortions require taking two drugs, mifepristone and misoprostol, up to 10 weeks into a pregnancy. They have been in use since 2000, and in 2016 the FDA eliminated the requirement that the first drug be administered in a hospital, clinic or doctor’s office. FDA experts said it was just as safe for a woman to take the medications at home.

But the FDA did not relax the requirement that women pick up the pills in person and sign for

As Trump hails Regeneron treatment, his administration tries to block the science it used

President Donald Trump has been celebrating the dose of experimental monoclonal antibodies he was given last Friday, saying he thinks it helped him vanquish his coronavirus infection in record time.



a sign on the side of a building: A logo sign outside of the headquarters of Regeneron Pharmaceuticals, Inc., in Tarrytown, New York on November 21, 2015. Photo by Kristoffer Tripplaar *** Please Use Credit from Credit Field ***


© Kristoffer Tripplaar/SIPA/Sipa USA/AP
A logo sign outside of the headquarters of Regeneron Pharmaceuticals, Inc., in Tarrytown, New York on November 21, 2015. Photo by Kristoffer Tripplaar *** Please Use Credit from Credit Field ***

“It was incredible the impact it had,” he said in a video he tweeted Thursday.

What he didn’t say is that the treatment was developed using technology his administration has worked for four years to ban.

It has to do with abortion politics, and the science of using human tissue to test and to make medicines. Regeneron’s therapy indirectly relied on tissue taken from an abortion.

Trump’s base, of course, is strongly against abortion rights and his administration acted quickly to reverse many Obama era policies — including policies that moved forward scientific research involving human fetal tissue.

Especially involved are human embryonic stem cells, made using days-old embryos, usually taken from fertility clinics. They’re left over from when couples make extra fertilized eggs and then do not need them. In the past, this tissue was also sometimes taken from abortions.

People against abortion rights oppose both uses, as does the Trump administration. The US Department of Health and Human Services has stopped the National Institutes of Health from obtaining any more fetal tissue for research and has set up a board that has virtually stopped it from funding any academic groups that use it.

The federal government cannot stop private industry from using fetal tissue and Regeneron supports its use.

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While Regeneron did not directly use human fetal cells to make the monoclonal antibody treatment given to Trump, it did use cells derived from an abortion in the Netherlands back in 1972 to make the targets for its antibodies — the mimics of the coronavirus’ spike protein.

Monoclonal antibodies home in on specific targets. To fight coronavirus, they are engineered precisely to attack the spike protein used by the virus to grapple onto cells. To make sure their antibodies were working right, Regeneron needed to use laboratory facsimiles of this spike protein, and for that, they used the fetal cells.

Scientists have used this batch of cells, called the HEK-293 cell line, for close to 50 years for all sorts of experiments. It’s one reason these embryonic stem cells are so valuable. They have a kind of immortality and flexibility that other cells do not. It’s why scientists fight so hard to keep access to this research, despite the efforts of anti-abortion activists.

“Research using such stem cells allows Regeneron to model complex diseases, test new drug candidates and can help unlock new scientific insights that ultimately could lead to the discovery of new treatments for people with serious diseases,”

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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The post NIH whistleblower quits, says administration ‘ignores scientific expertise’ appeared first on TheGrio.

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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 Will Cease Federal Funding to Hospitals That Do Not Report COVID-19 Data | Top News

(Reuters) – The U.S. Department of Health and Human Services will halt some federal funding to hospitals that do not comply with its requirements for reporting data on COVID-19, senior administration officials told reporters on a Tuesday call.

Starting Wednesday, hospitals will be given 14 weeks to provide daily reporting to HHS on COVID-19 cases and deaths, as well as other information such as influenza cases and use of personal protective equipment, the officials said.

Hospitals that fail to comply will lose access to reimbursement from Medicare and Medicaid, federal insurance programs for seniors, the disabled, and people with low incomes, they said.

The data will help coordinate the federal government’s response to COVID-19, including helping allocate supplies of antiviral drug remdesivir, and distribute its stockpile of personal protective equipment, such as surgical masks, said Deborah Birx, the White House Coronavirus Task Force coordinator.

HHS is requiring that hospitals provide daily influenza case reporting because of the likelihood flu season will intersect with the ongoing COVID-19 pandemic, the officials said.

“It is not certain what will happen this fall and winter, however the CDC is preparing for there to be COVID-19 and seasonal flu activity at the same time,” said Centers for Disease Control and Prevention director Robert Redfield.

Earlier this year, the U.S. government struggled to provide sufficient personal protective equipment to hospitals inundated with COVID-19 patients. It has also played a role in allocating Gilead Sciences Inc’s remdesivir to hospitals after U.S. regulators approved the antiviral drug in May for emergency use in some COVID-19 patients.

HHS took over responsibility for collecting hospitals’ COVID-19 data from the Centers for Disease Control and Prevention in July. News reports suggested the Trump administration move was aimed at bypassing the CDC, speculation the CDC director has rejected.

(Reporting by Carl O’Donnell; Editing by David Gregorio)

Copyright 2020 Thomson Reuters.

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