HHS Archives - Mediarabe

Cue Health awarded $481 mln to scale up production of COVID-19 test -HHS

October 13, 2020

Adds details of test kits

Oct 13 (Reuters) – The U.S. government has awarded diagnostic testing company Cue Health Inc $481 million to scale up the production of rapid COVID-19 molecular test, the Department of Health and Human Services said on Tuesday.

The company will raise the domestic production of COVID-19 test kits to 100,000 per day by March 2021 under the deal and deliver 6 million tests and 30,000 instruments to the government to support its response to the pandemic, the health agency said.

The point-of-care test can detect the novel coronavirus in about 20 minutes with nasal swab samples collected using a Sample Wand from the lower part of the nose, the HHS said.

The system also allows results to be sent to a mobile phone via an app.

The company’s test kit was approved by the U.S. Food and Drug Administration (FDA) in June for emergency

Cue Health awarded $481 million to scale up production of COVID-19 test: HHS

October 13, 2020

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(Reuters) – The U.S. government has awarded diagnostic testing company Cue Health Inc $481 million to scale up the production of rapid COVID-19 molecular test, the Department of Health and Human Services said on Tuesday.

The point-of-care test can detect the novel coronavirus in about 20 minutes with nasal swab samples collected using a Sample Wand from the lower part of the nose, the HHS said.

The system also allows results to be sent to a mobile phone via an app.

The company’s test kit was approved by the U.S. Food and Drug Administration (FDA) in June for emergency use in patient care settings under the supervision

HHS pushes back against Nevada’s rapid test pause for Covid-19

October 9, 2020

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The federal government is pushing back on an order from Nevada’s department of health to suspend rapid Covid-19 tests in nursing homes — suggesting the decision “can only be based on a lack of knowledge or bias,” according to a letter signed by Dr. Brett Giroir, assistant secretary for the U.S. Department of Health and Human Services.

The move comes one week after the Nevada Department of Health and Human Services mandated that long-term care facilities in the state stop using two Covid-19 antigen tests that had been supplied by the federal government.

Full coverage of the coronavirus outbreak

State health officials in Nevada said the antigen tests, which can deliver results within 15 minutes, had an unusually high number of false positives. That indicates a person is infected when in fact he or she is not.

Covid-19 antigen tests are designed to detect certain proteins on the surface of

HHS Secretary Azar says U.S. could have enough doses for every American by March

October 8, 2020

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Alex Azar, secretary of Health and Human Services (HHS), wears a protective mask during a House Select Subcommittee on the Coronavirus Crisis hearing in Washington, D.C., U.S., on Friday, Oct. 2, 2020. Azar is appearing before the committee to testify on the coronavirus crisis and the Trump administration’s portrayal of Covid-19 deaths. Photographer: Michael A. McCoy/The New York Times/Bloomberg via Getty Images

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Health and Human Services Secretary Alex Azar said Thursday the U.S. could have enough Covid-19 vaccine doses for every American as early as March, a more optimistic estimate than President Donald Trump has publicly said.

The Trump administration’s coronavirus vaccine program Operation Warp Speed expects to have up to 100 million doses by the end of the year, Azar said during a keynote speech at the Goldman Sachs Healthcare virtual event on the coronavirus. That’s “enough to cover especially vulnerable populations,” he

HHS whistleblower Rick Bright resigns from government

October 7, 2020

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“We can confirm that Dr. Bright has resigned, effective today,” an NIH spokesperson said, adding that the agency “does not discuss personnel issues beyond confirming employment.”

Bright was abruptly removed as director of the Biomedical Advanced Research and Development Authority in April and reassigned to NIH, and he alleges that he was demoted because he opposed political pressure linked to an unproven Covid-19 treatment. In his updated filing with the Office of Special Counsel, Bright said that he was assigned “no meaningful work” at NIH since Sept. 4, further alleging that NIH Director Francis Collins “declined to support” his recommendations about coronavirus testing “because of political considerations.”

Bright testified to a House panel in May that he was punished by Health and Human Services Department leaders for raising concerns about hydroxychloroquine, the drug favored by President Donald Trump to treat the coronavirus despite scant evidence. Bright also used the hearing

U.S. HHS announces further $20 billion funding to healthcare providers

October 3, 2020

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(Reuters) – The U.S. Department of Health and Human Services on Thursday announced a fresh round of $20 billion funding for frontline healthcare providers dealing with the COVID-19 pandemic.

The new allocation will take into account financial losses and changes in operating expenses caused by the coronavirus, the agency said, adding that providers that have already received relief fund payments can also apply for more funds.

Providers who have recently begun practice and behavioral health providers grappling with a surge in mental health and substance abuse issues since the virus outbreak can also apply.

The move comes as prevalence of symptoms of anxiety and depressive disorders surged in the second quarter compared to a year ago, according to a recent Centers for Disease Control and Prevention report https://www.cdc.gov/mmwr/volumes/69/wr/mm6932a1.htm.

Since the start of the pandemic, the U.S. government has announced billions of dollars in support for hospitals and medical providers to

HHS Secretary Alex Azar defends Trump’s decision not to wear a mask

October 2, 2020

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Health and Human Services Secretary Alex Azar on Friday defended the first family’s decision not to wear masks, one day after the president and first lady tested positive for the coronavirus. Azar said the first family is in a “different situation” than the rest of America.

“The first family and the protective aspect around the president is a different situation than the rest of us because of the protocols around the first family,” Azar said in response to questioning from Democratic Representative Nydia Velazquez during a House Coronavirus subcommittee hearing.

Azar made the statement after supporting mask use, adding “we recommend it.” In light of his endorsement, Velazquez asked the secretary how he is able to justify the president’s repeated decision not to wear a mask. “What is your reaction to the fact that the first family, that was sitting at the political debate — presidential debate were not

HHS Secretary Praises Department of Motor Vehicles for Their ‘Pivotal Role’ in Another Record-Setting Year in Organ Donation

September 29, 2020

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The Daily Beast

They Protested at a Police Station. They’re Charged With Trying to Kidnap Cops.

The July 3 protest in Aurora, Colorado, seemed, at least on the surface, like just another of the hundreds of racial justice protests that have swept the nation this year. Demonstrators sat outside a police station chanting and playing music. Although they said they wouldn’t leave until their demands were met, the protesters were cleared out by police around 4:30 a.m.Colorado Protest Erupts in Panic as Car Drives Into Crowd, Shots Fired But several of the protest leaders are facing felony attempted kidnapping charges for allegedly imprisoning police officers in their own precinct during the protest—charges their fellow activists are calling absurd.Lillian House, Joel Northam, and Whitney “Eliza” Lucero are among a group of Denver-area activists facing a slate of charges related to their protest activities this summer. Local prosecutors say the activists tried

HHS Issues Certification for Canadian Drug Imports

September 28, 2020

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Monday, September 28, 2020

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part plan to allow foreign prescription drugs to be imported into the United States in an effort to reduce drug prices (see here). Then in December 2019 they proposed two different pathways, the first called the “Section 804 Importation Program,” which is being implemented via notice-and-comment rulemaking, and the second called the “MMA Products Program” being implemented via an FDA guidance document. Our December 2019 blog post with a detailed explanation of the Section 804 proposed rule and draft FDA guidance document is available here.

Since those proposals were released and public comments for each solicited, the country and the world have changed drastically as a result of the ongoing

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