Dept. of Health & Human Services (HHS) Archives

HHS, DOD invest more than $562M to increase COVID-19 test manufacturing

U.S. Department of Health and Human Services (HHS)

The U.S. Dept. of Health & Human Services (HHS) and Defense Dept. (DOD), awarded more than $562 million for COVID-19 test manufacturing.

As part of the American Rescue Plan to boost manufacturing of key products that increase domestic testing supply, the more than $562 million went to a dozen U.S. companies to support the production of supplies including pipette tips, protective packaging, swabs and reagents, according to a news release.

HHS and DOD’s investments follow President Joe Biden’s announcements of efforts to make COVID-19 testing more available to Americans, including a $3 billion investment into rapid testing to increase the supply of at-home tests by four times by December.

Here are the companies that received awards as part of the $562 million investment from the U.S. government:

Nalge Nunc (Thermo Fisher Scientific subsidiary) – 192.5 million for domestic manufac…

New BD syringe manufacturing lines are up and running in Nebraska

BD (NYSE:BDX) announced today that it increased its manufacturing capacity and domestic supply for syringes and needles.

Franklin Lakes, N.J.-based BD’s new syringe and needle manufacturing lines, which were completed on an accelerated timeline, represent BD’s partnership with Department of Health and Human Services’ (HHS) Assistant Secretary for Preparedness and Response (ASPR).

Get the full story at our sister site, Drug Delivery Business News.

Biden administration invests $3B to accelerate development of next-gen COVID-19 treatments

President Joe Biden [Image courtesy of the White House]President Joe Biden’s administration will spend $3 billion in American Rescue Plan money to accelerate the discovery, development and manufacturing of antiviral medicines against COVID-19, HHS announced today.

Not only will the Antiviral Program for Pandemics seek to boost the availability of medicines to prevent serious COVID-19 illness and save lives, but it will pursue sustainable discovery and development platforms that could produce antivirals against future viruses that threaten to spark pandemics.

Get the full story on our sister site Drug Discovery & Development.

HHS wants investors to help prevent next pandemic

U.S. Department of Health and Human Services (HHS)

The U.S. Department of Health and Human Services (HHS) is turning to venture capital to speed the development of medical devices to stave off or fight public health emergencies.

HHS’s Biomedical Advanced Research and Development Authority (BARDA) plans to provide the nonprofit Global Health Investment Corporation (GHIC) with a minimum of $50 million over five years, with potential for up to $500 million over 10 years. GHIC will start a global health security fund with matching capital from other investors to identify, nurture and commercialize breakthrough technologies to aid the U.S. in responding effectively to future health security threats, according to HHS.

Get the full story on our sister site, Medical Design & Outsourcing.

Senate confirms new CMS leader

The U.S. Senate today confirmed President Joe Biden’s selection to lead CMS, Chiquita Brooks-Lasure, with a 55-44 vote in favor.

Brooks-Lasure will be the first Black woman to hold the position, according to Senate Majority Leader Chuck Schumer (D-N.Y.) on Twitter. She previously served in the U.S. Dept. of Health and Human Services during the Obama administration, during which time she helped to implement the Affordable Care Act, which she will now oversee as the Biden administration seeks to expand it.

“As we recover from the pandemic and build a stronger health care system, [CMS] needs experienced, steady leadership,” HHS Secretary Xavier Becerra wrote in a Tweet. “Chiquita Brooks-LaSure is that leader. Her confirmation as the first Black woman to lead CMS is historic, and I look forward to swearing her in this week.”

According to a report from The Hill, GOP lawmakers had opposed Brooks-Lasure’s nomination after the…

HHS shoots down ‘flawed’ plan to let some devices skip review

HHS Secretary Xavier Becerra (Image from Gage Skidmore on Flickr)

The Biden administration has nixed what it described as a “flawed” Trump-era decision to exempt certain medical devices — including infusion pump controllers and fetal monitors — from regulatory review.

HHS published the original notice in the Federal Register on Jan. 15, shortly before President Joe Biden was set to take office, without speaking with the FDA before doing so, according to an FDA notice set to appear in the Federal Register tomorrow.

Get the full story on our sister site, Medical Design & Outsourcing.

Companies, docs alarmed by proposed 510(k) rollback

Medical associations and device companies have largely come out against a Trump administration proposal to permanently exempt certain medical devices and software from the FDA 510(k) clearance process.

HHS used Trump’s waning days in office to propose permanently exempting 83 Class II devices and one unclassified device from the clearance review process. The list includes home ventilators, cardiopulmonary bypass pressure gauges, fetal cardiac monitors, long-term extracorporeal support systems, certain imaging software, ethylene oxide sterilizers and aerators, and certain masks (including N95 respirators), gloves and gowns. The agency also listed seven types of patient examination gloves that it has decided to immediately stop reviewing for 510(k) clearance. The notice was published on Jan. 15, 2021, in the Federal Register.

Get the full story on our sister site, Medical Design & Outsourcing.

Xavier Becerra confirmed as HHS secretary

Image from Gage Skidmore on Flickr

The U.S. Senate narrowly voted to confirm Xavier Becerra as the secretary of the U.S. Dept. of Health & Human Services (HHS) today.

Becerra received the nomination for the position from President Joe Biden in December 2020. Today, the Senate voted 50-49 in favor of Becerra, who will have to resign his seat as the attorney general of California. He will succeed Alex Azar, who held the position during the Trump administration until his resignation just days before Biden’s inauguration.

Get the full story at our sister site, Medical Design & Outsourcing.

Biden to put $12B toward COVID testing

(Image courtesy of the White House)

The Biden administration today pledged $10 billion for school COVID-19 screenings and $2.25 billion for screenings and diagnostic testing among underserved populations.

The money is part of the $1.9 trillion American Rescue Plan Act that Biden signed into law last week.

The Department of Health and Human Services will divvy up the $10 billion among the states to fund screening tests of teachers, staff and students to help schools to reopen safely for in-person instruction. Screening tests are used to test asymptomatic people for COVID-19. The money will be deployed quickly to help schools reopen for the remainder of this year, according to an HHS news release.

Get the full story on our sister site, Medical Design & Outsourcing.

Feds to spend $1.6B to expand COVID testing, domestic manufacturing

(Image from the CDC)

The Biden administration announced plans today to expand COVID-19 testing across the country, boost domestic manufacturing of tests and testing supplies and increase virus genome sequencing to detect virus variants.

The departments of Health and Human Services and Defense will jointly invest $650 million to expand testing for K-8 schools and underserved congregate settings, such as homeless shelters, directly through new regional coordination “hubs.” The move will also include working with laboratories, including at universities, to collect specimens, perform the tests and report results to the relevant public health agencies for up to 25 million additional tests per month.

Get the full story on our sister site, Medical Design & Outsourcing.

Retractable Technologies lands $54.2M federal contract for syringes

Retractable Technologies (NYSE:RVP) announced that it received a government contract worth more than $54.2 million for its syringes.

Little Elm, Texas-based Retractable Technologies’ contract and purchase order was made by the U.S. Health & Human Services Dept. (HHS) with a base price of $54,217,800 for a five-month period between Feb. 15, 2021, and July 14, 2021.

Get the full story at our sister site, Drug Delivery Business News.

Feds order 200M more vaccine doses from Pfizer, Moderna

[Photo by Daniel Schludi on Unsplash]U.S. government agencies announced that they purchased a total of 200 million additional doses of COVID-19 vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA).

The orders of 100 million doses from each of the only two FDA-authorized vaccines in the U.S. were made by the U.S. Health & Human Services Dept. (HHS) and the Defense Dept. (DoD). The U.S. has now purchased a total of 600 million doses, according to a news release, with the totals of the two-dose vaccines allowing for the vaccination of 300 million people.

Each company is set to deliver 300 million doses in regular increments through the end of July 2021 while leveraging U.S.-based manufacturing capacity to produce in bulk.

“As the President directed, we are expanding our supply of COVID vaccines to protect people as quickly as possible,” Acting HHS Secretary Norris Cochran said in the release. “These purchases will allow us to accelerate our vaccination …