Labor unions, environmental groups demand federal action on PPE

(Photo by SJ Objio on Unsplash)

A group of labor unions and environmental organizations is petitioning the Trump Administration to mandate production of personal protective equipment (PPE) using the Defense Production Act.

The petition, submitted Aug. 11 to the U.S. departments of Health and Human Services and Homeland Security, dovetails with the FDA’s issuance on Monday of its first list of PPE shortages, which includes surgical gowns, gloves, testing supplies and ventilation-related products for the sickest patients. PPE shortages have plagued the U.S. since the COVID-19 pandemic spread to this country.

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HHS puts $6.5M more toward COVID-19 testing

The U.S. Department of Health and Human Services (HHS) said today it will provide a total of $6.5 million to help two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional diagnostic tests for COVID-19 per month.

The investments in Aegis Sciences (Nashville, Tenn.) and in Sonic Healthcare USA (Austin, Texas) will provide laboratory equipment supplied by Beckman Coulter and Thermo Fisher Scientific (NYSE:TMO) and increase staffing and infrastructure to boost testing nationwide by an  additional 1 million tests each week by early October, according to the agency.

Aegis will add laboratory staff and begin construction on new lab space at its Nashville testing facilities to meet its goal of processing more than 60,000 test samples per day beginning in September. Aegis has agreed to partner with the Office of the Assistant Secretary for Health to perform testing of samples from select locations with vulnerable populations, accor…

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Ventec to take over ventilator production at GM plant

(Image courtesy of Ventec)

Ventec Life Systems and General Motors have delivered more than 20,000 ventilators they built together at a GM plant, and GM plans to turn over production to the medtech company once their federal contract is completed, Ventec announced this week.

Production of Ventec’s V+Pro critical care ventilators at the Kokomo, Ind., GM plant began in April, with delivery to the Strategic National Stockpile to help COVID-19 patients. GM and Ventec have a $489.4 million contract from the U.S. Department of Health and Human Services to ship  30,000 machines by the end of August.

As demand for critical care ventilators continues with the spread of COVID-19, GM has agreed to hand off control of production at the Kokomo plant to Ventec, which said it will continue expanded production at its headquarters in Bothell, Wash.

“During this pandemic, ven…

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Report: Will Dr. Hahn crack under political pressure?

Many jobs have come with increased stress levels during the coronavirus pandemic, from ICU staff to Walmart greeters. Now officials who’ve been keeping tabs on FDA commissioner Dr. Stephen Hahn are wondering whether he can weather the strain of defending science while working for the Trump administration, according to a New York Times report.

Hahn has been squeezed between expressing his professional opinions and toeing the administration line on topics such as hydroxychloroquine and COVID-19 vaccines. (Hydroxychloroquine may cause a heart rhythm disorder or drug-induced sudden cardiac death, according to the Centers for Disease Control and Prevention (CDC).) He has gamely fielded questions raised about statements made by President Trump — including on whether the coronavirus is deadly and the possibility of a vaccine being will be ready by Election Day, November 3, 2020.

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More than $500m wasted on Philips ventilator contract, House report says

Philips Trilogy EVO portable ventilator (Image courtesy of Philips)

A Congressional report today accused the Trump administration of bungling plans to obtain ventilators early in the coronavirus pandemic and claimed that federal officials squandered more than $500 million in a contract with Philips (NYSE:PHG).

The House Subcommittee on Economic and Consumer Policy began an investigation in April into a federal contract with Philips to determine why the country lacked enough ventilators during the initial months of the coronavirus pandemic. According to the report:

The Obama administration contracted with Philips in 2014 to supply the nation’s stockpile with 10,000 ventilators by June 2019. That administration later gave Philips an extension through October 2019. Philips delayed delivery through 2017 and 2018, and the Trump administration mismanaged Philips’ repeated failures to meet contractual require…
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HHS seeks 20m point-of-care COVID-19 antibody tests per month

(Image courtesy of The White House)

The federal government wants U.S. diagnostics companies to develop rapid point-of-care COVID-19 antibody tests — using only materials made in the USA.

The Department of Health and Human Services (HHS) on Thursday issued the call for submissions from companies that can quickly begin production of more than 20 million such tests per month. The tests must be suitable for use by non-professionals, accurate and low-cost.

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HHS taps Pfizer to produce millions of COVID-19 vaccine doses

[Photo by Fusion Medical Animation on Unsplash]

Two U.S. government agencies today announced an agreement with Pfizer (NYSE:PFE) for production and delivery of 100 million doses of a COVID-19 vaccine.

The U.S. Dept. of Health and Human Services, along with the U.S. Defense Dept., agreed to the large-scale production and U.S. delivery deal once Pfizer’s vaccine is successfully manufactured and approved. In addition to the 100 million doses initially agreed upon. the U.S. government will be able to acquire an additional 500 million doses.

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340 organizations ask Congress for telehealth to stay

Today, 340 companies signed a letter sent to Congress to urge leaders to make COVID-19-related telehealth flexibilities permanent.

Representing all 50 states, Washington, D.C., and Puerto Rico, the signees are seeking to stop the potential for telehealth flexibilities to disappear, should Congress fail to act before the COVID-19 public health emergency expires, according to a news release.

At the beginning of the pandemic, Congress waived statutory barriers to allow for expanded access to telehealth, offering federal agencies the flexibility to allow healthcare providers to deliver care virtually. The letter says that those flexibilities will immediately go away if Congress doesn’t act.

The 340 stakeholders who signed the letter urged Congress to remove obsolete restrictions on the location of the patient so care can be accessed at home, maintain and enhance Dept. of Health & Human Services (HHS) authority to determine appropriate providers for…

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HHS spending $347m to boost supply of COVID-19 vaccine, treatment vials

The U.S. Dept. of Health & Human Services (HHS) and Dept. of Defense (DoD) announced a joint effort to increase manufacturing for vials earmarked for COVID-19-related drugs and vaccines.

The Biomedical Advanced Research and Development Authority (BARDA), as part of HHS, collaborated with DoD to provide funding for U.S.-based companies Corning Inc. and SiO2 Materials Science.

Under the Trump Administration’s “Operation Warp Speed,” HHS and DoD plan to scale up domestic manufacturing capacity for the vials that could be needed for vaccines and drugs in response to the ongoing COVID-19 pandemic, as well as future public health emergencies, according to a news release.

BARDA is partnering with and offering $204 million to Corning in return for manufacturing capacity expansion to produce an additional 164 million Valor glass vials each year if needed. Corning will accelerate manufacturing at its facilities in Durham, N.C., Big Flats, N.Y…

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