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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

FDA faults quality control at Lilly plant making Trump-touted COVID drug

By Dan Levine and Marisa Taylor

(Reuters) – U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President Trump as “a cure” for the disease, according to government documents and three sources familiar with the matter.

The Lilly antibody therapy, which is experimental and not yet approved by regulators as safe and effective, is similar to a drug from Regeneron Pharmaceuticals that was given to the president during his bout with COVID-19.

Trump, who credits the Regeneron drug with speeding his recovery, has called for both therapies to become available immediately on an emergency basis, raising expectations among some scientists and policy experts that the administration will imminently release an Emergency Use Authorization (EUA) for the drug. The president’s push is key to his efforts to convince voters he has an answer to the pandemic that has killed more than 215,000 Americans.

But the findings by the U.S. Food and Drug Administration inspectors at the Lilly manufacturing facility, which have not been disclosed previously, could complicate the drugmaker’s bid for a so-called emergency use authorization (EUA) from the federal agency, two of the sources and two outside legal experts told Reuters. That’s because U.S. law generally requires compliance with manufacturing standards for authorization of a drug.

The three sources who spoke to Reuters requested that their names be withheld so they could speak freely without fear of retaliation.

Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant’s various manufacturing processes had been deleted and not appropriately audited, government inspection documents show.

“The deleted incidents and related audit trail were not reviewed by the quality unit,” the FDA inspectors wrote. Because the government inspection documents reviewed by Reuters were heavily redacted by the FDA it was not possible to see the inspectors’ more specific findings.

Following its November inspection, the FDA classified the problems as the most serious level of violation, resulting in an “Official Action Indicated” (OAI) notice.

That “means that the violations are serious enough and have a significant enough impact on the public health that something needs to be fixed,” said Patricia Zettler, a former associate chief counsel at the FDA who is now a law professor at Ohio State University.

Separately, Lilly said on Tuesday it had paused its clinical trial for the COVID drug in hospitalized patients “out of an abundance of caution” over a potential safety concern. The company did not release information on what the problem was and declined to say how the news might affect their EUA request.

In response to Reuters’ questions on Monday about the manufacturing issues, Lilly confirmed the OAI notice but declined to provide details on what prompted the FDA action. The drugmaker said it has launched a “comprehensive remediation plan,” has increased staffing at the site and was working “aggressively” to address all concerns raised during

Trump sparks new FDA concerns with praise of ‘miracle’ treatment

President Trump’s public praise for an experimental coronavirus antibody treatment is putting new pressure on the Food and Drug Administration (FDA) to quickly give emergency clearance to a drug he has touted as a “miracle.”



a person sitting on a table: Trump sparks new FDA concerns with praise of 'miracle' treatment


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Trump sparks new FDA concerns with praise of ‘miracle’ treatment

Doctors think the drugs show promise as a potential treatment of COVID-19, though Trump has created confusion by quickly elevating them to a cure.

“They call them therapeutic, but to me it wasn’t therapeutic,” Trump said in a video he tweeted on Wednesday, five days after receiving the experimental treatment from the biotech company Regeneron.

Trump said that he felt better immediately after taking the drugs.

“I call that a cure,” he said. “It’s a cure.”

But by placing himself in the middle of the drug evaluation process, Trump is once again igniting concerns that politics is encroaching on science at a crucial time.

The pressure threatens to undermine confidence in government regulators and turn the science of drug evaluation into yet another political dispute, confusing Americans and sowing distrust about helpful therapies.

Former FDA Commissioner Scott Gottlieb said the agency should grant emergency authorization to antibody treatments like the one Trump took, and people shouldn’t be so quick to attack such a promising therapy.

“I hope people don’t shoot at these drugs because there’s this political veneer over access to this. We should just look at the scientific merits,” Gottlieb said Friday on CNBC.

Gottlieb also said the safety bar for antibody treatments is lower than it is for vaccines because the science for antibodies is better understood.

“These drugs, based on the data we’ve seen publicly, probably meet the bar for an emergency use authorization. They’re different from a vaccine, a vaccine you’re going to have a much higher threshold for safety,” Gottlieb said.

Two companies have filed for emergency use authorization for antibody drugs in the past week: Regeneron and Eli Lilly. The treatment from Eli Lilly consists of a single monoclonal antibody, while the treatment from Regeneron consists of a cocktail of antibodies.

Monoclonal antibodies are lab-generated versions of one of the human body’s main defenses against pathogens.

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Doctors and health experts think antibody drugs could be a bridge to a COVID-19 vaccine, but have cautioned that the results to date are very preliminary and longer studies are needed.

“I think there’s an efficacy signal here. But it’s a very selective part of the patient population,” said Jesse Goodman, a professor at Georgetown University who was FDA’s chief scientific officer during the Obama administration.

Regeneron issued a press release touting its preliminary results, but has not publicly released any data. According to the company, a high dose of its drug led to reduced levels of the virus in non-hospitalized patients with mild to moderate symptoms.

Eli Lilly’s submission was based on studies showing that its antibody

FDA Panel: All Thumbs Down for Amphetamine Product Meant to Deter Abuse

An FDA advisory committee voted unanimously Thursday that the risks of a novel amphetamine designed to deter abuse outweighed the benefits, concluding it may in fact be misused and could be even more dangerous than conventional stimulant medications for attention deficit-hyperactivity disorder (ADHD).

The panel also voted 19-2, with two abstentions, that drugmaker Arbor Pharmaceuticals did not adequately address the safety of AR19 (amphetamine sulfate), with many panelists noting that the drug appeared safe when administered orally, but that high levels of talc and polyethylene oxide in the drug’s composition could be toxic if taken through snorting or injection.

The joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee also concluded with a 15-8 vote that Arbor did not adequately demonstrate AR19 would deter intravenous use, and voted 19-4 that it did not adequately demonstrate it would deter intranasal use.

In fact, the product’s ability to deter manipulation was “slim to nonexistent,” while the risks of the excipients were “too high and uncharacterized” to establish safety, said panel member Steven B. Meisel, PharmD, of M Health Fairview in Minneapolis.

The immediate release, pellets-in-capsule drug contains the same active ingredient as Arbor Pharmaceuticals’ currently-approved ADHD amphetamine Evekeo, but with physical and chemical barriers to deter non-oral intake.

Many panelists agreed that an abuse-deterrent amphetamine would be beneficial. But the likely impact on abuse would be relatively small, they said.

Moreover, the vast majority of amphetamine abuse occurs through the oral route, and non-oral misuse often starts with oral misuse, said Sonia Hernandez-Diaz, MD, MPH, DrPH, of the Harvard T.H. Chan School of Public Health in Boston. AR19 was not proposed to deter oral abuse.

“I think this approach would make sense if manipulation were working very well and [AR19] was the only amphetamine on the market,” Hernandez-Diaz added.

The conclusions of the panel may come as no surprise after the skeptical review FDA staff gave the product received in advance of Thursday’s meeting. Agency scientists wrote that it was feasible to extract a minimum reinforcing dose (10 mg amphetamine per mL over 1 minute) suitable for injection when using higher doses of AR19.

Arbor’s own studies aimed at determining whether manipulation could allow the drug to be snorted showed that ordinary household tools couldn’t significantly reduce particle size. But with modifications, one tool was able to crush AR19 particles down to snortable size.

Philip Posner, PhD, the panel’s patient representative from Gainesville, Florida, voted yes to both the intranasal and intravenous deference questions. He argued the evidence showed users would be far less likely to abuse AR19 compared to other stimulants on the market.

“When you compare this product with everything else that’s on the market, or that students can get elsewhere, I think they’re going to take the easy way out,” Posner said. “They’re not going to go through the excess work of emptying capsules, crushing tablets, and putting them in powder form to snort.”

That view failed to persuade Karim Anton

Regeneron asks for emergency FDA approval for COVID-19 antibody treatment

Oct. 8 (UPI) — Biotechnology company Regeneron has requested emergency use authorization from federal regulators for a COVID-19 antibody treatment.

The REGN-COV2 treatment is a combination of two antibodies that’s designed to “block infectivity” of the SARS-CoV-2 virus that causes COVID-19.

“The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population,” the company said in a statement.

Regeneron, which asked the Food and Drug Administration for the emergency authorization, said it has doses available for 50,000 patients and will have enough for another 300,000 in the coming months.

“If [emergency use authorization] is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution,” the company added.

President Donald Trump took a dose of the Regeneron cocktail last week after he tested positive for COVID-19, even though it hasn’t been approved by the FDA.

Regeneron said if its request is approved, it will distribute the treatment in the United States and partner Roche will distribute overseas.

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Regeneron Asks FDA for Emergency Use Authorization of Coronavirus Therapy Used to Treat President Trump | Health News

Regeneron announced Wednesday night that it has asked the Food and Drug Administration for emergency use authorization for the experimental coronavirus antibody therapy used to treat President Donald Trump after he tested positive for the virus.

The biotechnology company said in a statement that it made that emergency use request for its REGN-COV2 investigational antibody combination for COVID-19. If the emergency authorization is granted, the government has committed to making it available to Americans at no cost and would be responsible for its distribution, the statement said.

Enough doses are currently available for 50,000 coronavirus patients, and the company expects to have 300,000 doses within the next several months.

Cartoons on the Coronavirus

The experimental treatment is still in large-scale clinical trials but has been available for compassionate use, something the FDA approves on a case-by-case basis, such as the case with the president.

REGN-COV2 is a combination of two monoclonal antibodies designed specially to block SARS-CoV-2, the virus that causes COVID-19. Regeneron scientists sorted through thousands of human antibodies, including from people who recovered from COVID-19, to choose ones that fought the virus most effectively.

Scientists chose two virus-neutralizing antibodies, scaled them up and put them into a medication in hopes that it could treat virus symptoms and possibly be used as a preventative measure.

The president received an 8 gram dose of the treatment on Friday at Walter Reed National Military Medical Center following his coronavirus diagnosis. Trump called the treatment “unbelievable” and said he “felt good immediately.”

Early data from the company’s clinical trials have shown that the treatment is effective and safe, with few side effects.

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Regeneron requests EUA from the FDA for coronavirus treatment

Regeneron’s stock price rose over 4% in premarket trading Thursday after the company submitted an “emergency use authorization” request to the U.S. Food and Drug Administration for its Covid-19 antibody treatment.

Its REGN-COV2 monoclonal antibody coronavirus therapy is what President Donald Trump took last week after being diagnosed with Covid-19. He has since described it as a “cure” even though there’s no such scientific proof. 

The biotech company published a statement Wednesday noting that “if an EUA is granted the  government has committed to making these doses available to the American people at no cost and would be responsible for their distribution.”

The treatment is now available for about 50,000 patients, Regeneron said, “and we expect to have doses available for 300,000 patients in total within the next few months.”

REGN-COV2 is a combination of two monoclonal antibodies and was “designed specifically to block infectivity” of the virus that causes Covid-19.

Trump was given an 8 gram dose of the antibody cocktail early in the course of his infection, despite it not being authorized by the FDA. 

Regeneron said preclinical studies have shown that REGN-COV2 reduced the amount of virus and associated damage in the lungs of non-human primates. The company has recently partnered with Roche to increase the global supply of REGN-COV2, if approved.

“If REGNCOV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. (beyond the initial U.S. Government supply) and Roche will develop, manufacture and distribute it outside the U.S.,” the company said.

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Trump returns from Walter Reed, White House backs FDA vaccine guidelines

The White House has reportedly backed away from a battle with the U.S. Food and Drug Administration (FDA), which has been advancing a timeline for a coronavirus vaccine that suggested an approval wouldn’t happen before Election Day.

The FDA has said it will need two months of observation in late-stage trials of any coronavirus vaccine in order to consider an emergency use authorization — an objective that conflicted with President Donald Trump’s desire to have an inoculation by early November. However, the White House signed off on the new guidelines Tuesday afternoon, backing away from a potential standoff that had worried health experts.

Trump, fresh from a stint in the hospital after being diagnosed with COVID-19, re-ignited the political debate over a vaccine timeline, putting him at odds with the FDA. In a video Monday evening, Trump also said that “vaccines are coming, momentarily” — even as FDA guidelines suggest a release wouldn’t happen until well after Election Day.

Trump said as much late Tuesday on Twitter, tagging FDA Commissioner Stephen Hahn while posting, “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!”

The White House was previously citing pharmaceutical companies’ objections to the two-month period.

Pfizer (PFE) CEO Albert Bourla said Tuesday the company has not been in touch with the White House on the topic and “we believe (FDA)’s independence is today more important than ever as public trust in (COVID-19) vaccine development has been eroded by the politicization of the process.”

In interviews in the past 24 hours, FDA’s top vaccine official, Dr. Peter Marks said a minimum of 7 weeks would be acceptable.

“We’ve made it clear we want to see a median of two months of follow-up for any of the vaccines…while it would be nice to have much more, we have to balance the safety we get up front with the need to try to save lives,” Marks said in an interview with the Journal of the American Medical Association.

He added that an emergency use authorization of a vaccine is likely by the end of the year, since it only takes weeks to review an EUA filing, compared to months of review for a full license approval.

But even that EUA filing could remain a question. Moncef Slaoui, head of Operation. Warp Speed, said during a symposium co-hosted by Johns Hopkins University and the University of Washington that he has advised companies not to file for an EUA until they have enough vaccine to distribute.

A critical date will come on October 22, the date established by a key FDA advisory body to determine official guidelines, even though Trump could still override any decision made then.

“Data from Phase 3 studies that includes a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” according to the Vaccines and Related

Regeneron asks FDA for emergency authorization of its Covid-19 antibody therapy that was given to Trump last week

Regeneron says it has applied to the US Food and Drug Administration for emergency use authorization for its experimental monoclonal antibody therapy, the same antibody cocktail given to President Donald Trump Friday after he was diagnosed with the virus.



a woman preparing food in a kitchen: New York state based biotech company, Regeneron is working on an antibody therapy to treat, and possibly prevent, Covid-19.


© Regeneron
New York state based biotech company, Regeneron is working on an antibody therapy to treat, and possibly prevent, Covid-19.

The biotechnology company confirmed it had submitted the application for the authorization in a statement on its website Wednesday night.

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“Under our agreement with the U.S. government for the initial doses of REGN-COV2, if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution,” the statement said. “At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months.

Regeneron’s experimental antibody treatment is still in large-scale clinical trials, but has been available for compassionate use, something the FDA has to approve on an individual basis, like it did for the President.

The antibody therapy is a combination of two monoclonal antibodies that is designed specifically to block infectivity of SARS-CoV-2, the virus that causes Covid-19, according to the company’s statement.

A cocktail antibody therapy uses two or more lab-engineered antibodies. Regeneron’s cocktail includes a monoclonal antibody that targets the spike protein the virus uses to drill into healthy cells, and another antibody that targets a different part of the novel coronavirus. With two, the hope is to trap and shut down viral replication.

“When you weigh the potential benefit versus the risks, the downsides are very low here because we have not seen any safety concerns,” Regeneron CEO Dr. Leonard Schleifer told CNN in an interview after Trump received an 8 gram dose of the treatment.

Early data from the company’s antibody trials released recently showed it worked fairly safely with few side effects.

“This class of drugs is an extremely safe class,” Schleifer said.

Dr. Richard Besser, a former acting director of the US Centers for Disease Control and Prevention who now heads the Robert Wood Johnson Foundation, said it makes sense that a treatment that gives a patient antibodies would help the immune system, but he said peer review will find any holes or pitfalls.

“I would withhold judgment on this until we see the data,” Besser said. “You know these early results that keep coming out from companies in press releases strike me as being … much more about the stock price than they are about science.”

But Dr. Thomas Frieden, also a former CDC director, disagreed with Besser.

Although Regeneron’s antibody therapy is unproven, it is “a promising treatment,” Frieden told CNN.

“There’s a report that only fewer than 300 patients have received it,” he said. “It seems to be most effective early in the disease, especially before patients make antibodies of their own.”

“We don’t know if it’ll be

Eli Lilly Seeks FDA Approval On Coronavirus Treatment, Potentially Easing Rush For A Vaccine

KEY POINTS

  • Eli Lilly’s three trials over the summer yielded positive results in patients with mild- to moderate-cases of coronavirus
  • The company could have nearly 1 million doses ready for distribution by the end of 2020 with FDA approval
  • Temporary protections provided by the antibody treatment could potentially give pharmaceutical companies more time to develop stronger vaccines

Pharmaceutical company Eli Lilly & Co. asked the U.S. Food and Drug Administration Wednesday to authorize the use of a potential coronavirus treatment that’s shown promising results during clinical trials.

Eli Lilly asked the FDA to authorize the drug’s emergency use after results for their first three clinical trials all came back positive in people with mild- to moderate-cases of coronavirus. If approved, Eli Lilly said it could have 100,000 doses ready to go within a month and 1 million ready by the end of 2020.

However, it would not be used on more severe cases, since it has not proven to be as effective in treating those cases.

The drug, codenamed LY-CoV555, is in an antibody drug Eli Lilly has been developing with Canadian pharmaceutical company AbCellera Biologics Inc. AbCellera started by taking blood samples from one of the first coronavirus patients in the U.S. to recover when it began working with Eli Lilly. The two then started developing an antibody drug treatment based on the antibodies found in the patient’s blood sample.

Trials began in June, when hospitalized patients being treated for coronavirus were dosed randomly with either the drug or a placebo to measure the drugs effectiveness. After results showed the drug helps treat the virus, phase 2 trials were conducted among vulnerable populations who were randomly administered a placebo or one of two potential drugs, including alternate antibody treatment LY-CoV016.

The most recent trials were conducted in nursing homes and, as before, showed the drug helped treat the symptoms of coronavirus and could temporarily protect against it. The latter half of the results would be important because it could ease the pressure on other pharmaceutical companies to develop a full vaccine.

One company which would benefit from this, in that regard, is AstraZeneca Plc. U.S. trials for AstraZeneca’s potential vaccine have been on hold since September after one patient was diagnosed with unexpected neurological symptoms after being inoculated. Trials have continued overseas.

That said, AstraZeneca may still rush to get a vaccine out as its pledge not to profit from it runs through July 2021. Under its current contractual agreement, Astrazeneca could declare the pandemic over by then and begin profiting off its distribution. The period could be extended if AstraZeneca acts “in good faith” if the pandemic is not considered over.

The company said it expects to receive an update about possibly resuming its U.S. trials in the next two weeks.

Nita Patel, director of antibody discovery and vaccine development at Novavax, lifts a vial containing the company's experimental Covid-19 vaccine Nita Patel, director of antibody discovery and vaccine development at Novavax, lifts a vial containing the company’s experimental Covid-19 vaccine Photo: AFP / ANDREW CABALLERO-REYNOLDS

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