HHS to support more healthcare products manufacturing

HHS will fully establish a program to provide loans, grants and other types of funding to expand the U.S. health resources industrial base, the White House announced today.

The news was part of a package of actions the Biden administration is taking to support American manufacturing and boost supply chains.

During the COVID-19 pandemic, HHS created a Defense Production Act office to use the Korean War–era law to break through bottlenecks in the supply chain and spend funds to combat shortages of needed medical supplies. Now, HHS will fully establish a DPA Title III Program.

Today’s announcement out of the White House also included news that the Treasury Department will deploy $10 billion of American Rescue Act funds under a new and improved State Small Business Credit Initiative (SSBCI). The move will leverage the funds into more than $70 billion in additional lending and investment for small businesses, including small manufacturers.

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HHS to support more manufacturing of APIs, other healthcare products

HHS will fully establish a program to provide loans, grants and other types of funding to expand the U.S. health resources industrial base, the White House announced today.

The news was part of a package of actions the Biden administration is taking to support American manufacturing and boost supply chains.

The White House briefing statement said: “The United States remains critically dependent on imports for a range of key pharmaceutical products and active pharmaceutical ingredients—the primary ingredients of generic drugs.”

During the COVID-19 pandemic, HHS created a Defense Production Act office to use the Korean War–era law to break through bottlenecks in the supply chain and spend funds to combat shortages of needed medical supplies. Now, HHS will fully establish a DPA Title III Program.

“This program will ensure timely availability of essential domestic industrial resources; establish the necessary authorities and mechanis…

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President Biden reboots Cancer Moonshot project

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In 2016, then-Vice President Joe Biden announced a Cancer Moonshot initiative to speed the development of new therapies to treat cancer.

Biden is now launching a new initiative committed to improving the cancer survival rate by at least 50% by 2047. The plan also aims to improve the quality of life for patients with cancer.

“We can end cancer as we know it,” Biden said in an announcement introducing the initiative.

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

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Addressing vulnerabilities in the medical product supply chain

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While the medical product supply chain has always been subject to vulnerabilities, those weaknesses were laid bare early in the COVID-19 pandemic. Drug and medical device supply chains have historically been susceptible to factors such as a lack of supplier redundancy, components, active pharmaceutical ingredient (API) or finished product manufacturers. But pandemic-driven sourcing and workplace disruptions magnified these pain points, resulting in the ongoing problems that have persisted for the past two years.

Although the root causes are complex and the possible solutions numerous, important developments at the U.S. Food and Drug Administration (FDA) have led to increased transparency about drug and medical device shortages. Although this transparency is a promising starting point for formulating short- and long-term supply chain solutions, strong policy development, planning and …

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President Biden reboots Cancer Moonshot project 

Image courtesy of Wikipedia

In 2016, then-Vice President Joe Biden announced a Cancer Moonshot initiative to speed the development of new therapies to treat cancer.

Biden is now launching a new initiative committed to improving the cancer survival rate by at least 50% by 2047. The plan also aims to improve the quality of life for patients with cancer.

“We can end cancer as we know it,” Biden said in an announcement introducing the initiative.

Biden named Dr. Danielle Carnival as the White House Cancer Moonshot coordinator. Carnival is currently the senior advisor to the director of the White House Office of Science and Technology Policy.

One of the short-term goals of the initiative will be to bolster cancer screening rates, which have plummeted during the pandemic.

Biden seeks to form a Cancer Cabinet with officials from a range of government offices.

Biden als…

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US buys 10 million additional courses of Pfizer’s COVID-19 pill Paxlovid 

As COVID-19 infections in the U.S. hit new highs, President Joe Biden announced that the country would buy at least 20 million courses of Pfizer’s (NYSE:PFE) COVID-19 pill Paxlovid. 

The government had planned on purchasing half as much of the drug, which won regulatory authorization in late December for certain patients with a high risk of developing severe COVID-19. 

Biden also vowed that it had offered Pfizer additional resources to accelerate the manufacture of the drug. 

The federal government is ready to use the Defense Production Act to spur quicker production of the drug.  

Pfizer plans on providing roughly 10 million treatment courses to the government by the end of June. It plans on providing the additional 10 million courses by September 30. 

Pfizer has previously announced that Paxlovid had an efficacy rate of 89% in a study focused on its potential to reduce hospitalization or death from COVID-19. The Phase 3 study involv…

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Biden announces plans to buy, distribute 500M at-home, rapid COVID-19 tests

[Photo by Martin Sanchez on Unsplash]The White House today announced a COVID-19 response plan that includes a large effort to increase at-home rapid testing.

President Joe Biden’s plan includes the opening of new federal testing sites to increase capacity and the distribution of 500 million at-home, rapid tests to Americans.

The Biden administration plans to purchase a half-billion rapid tests this winter with intentions to distribute them for free to those who want them. The initial delivery is slated to begin in January 2022, with the administration planning to put up a website for Americans to request their at-home tests.

Additionally, according to a news release, new federal testing sites will be set up around the U.S., with the first set to go up in New York City this week.

Biden also said the plan includes utilizing the Defense Production Act to accelerate production, making sure the U.S. is “producing as many tests as quickly as po…

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OSHA suspends enforcement of COVID-19 vaccine mandate

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The Biden administration will not proceed with enforcing its vaccine mandate for businesses with at least 100 employees given a recent decision by the U.S. Court of Appeals for the Fifth Circuit.

The administration had planned on putting the Occupational Safety and Health Administration (OSHA) in charge of administering the COVID-19 vaccine mandate. While a statement on the OSHA website proclaims that it “remains confident in its authority to protect workers in emergencies,” the agency agreed it would suspend enforcement of the emergency temporary standard (ETS) that would have required many U.S. employees to be fully vaccinated or face regular testing. However, OSHA could change course in the event of a further court order.

The U.S. Court of Appeals for the Sixth Circuit will hear the challenge to the OSHA-specific vaccine mandate.

For the time being, however, OSHA h…

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States sue to block COVID-19 vaccine mandate

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The attorneys general in 26 U.S. states are opposing the Biden administration’s plan to force many employers to require their workers to obtain vaccination against COVID-19.

While the majority of states were Republican-led, Kansas, Louisiana and Kentucky were three Democratic-leaning states that joined the litigation.

White House spokeswoman Karine Jean-Pierre said in a media briefing that the vaccine mandates have a firm legal footing.

The vaccination mandate threatens penalties of almost $14,000 per infraction.

The federal government intends to begin enforcing the rules on January 4.

The rules are more stringent for healthcare facilities receiving funding from Medicare and Medicaid. In such facilities, eligible staff must receive at least one vaccine dose before providing healthcare, treatment or other services by December 5.

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Biden’s COVID-19 vaccine mandate goes into effect

President Biden first signaled his intent to require many American workers to obtain full vaccination against COVID-19 in September. 

Now, a significant number of employers must ensure their workers are either vaccinated or tested weekly for COVID-19 by January 4 as the rules become official. The requirements will apply to employers with at least 100 employees, translating to approximately 84 million workers. 

At present, roughly two-thirds of Americans have received at least one dose of a COVID-19 vaccine, and just over 58% of the U.S. public is fully vaccinated, according to CDC. In addition, about one in ten people have received a booster dose. 

Several other countries have substantially higher vaccination rates, including the United Arab Emirates, Portugal, Spain, Israel, Singapore, Japan and Canada. 

The federal requirements also enable workers to receive paid time off to obtain vaccine doses and sick time to deal with side effects.  

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White House reveals plan to vaccinate children aged 5 to 11 

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The White House says that vaccination will be readily available and free of charge for children between the ages of five and 11, assuming the FDA and CDC authorize them.

The authorization of a vaccine for that age group would make 28 million additional Americans eligible for vaccination.

Pfizer recently asked FDA to extend emergency use authorization (EUA) to its vaccine, which it jointly developed with BioNTech.

An FDA advisory committee will convene on October 26 to discuss Pfizer’s request to amend the EUA. While some members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) have signaled concern about the risk of myocarditis linked to mRNA vaccines in children in the past, clinical trial data suggest the vaccines are safe and effective in five- to eleven-year-olds.

The White House said it would begin dispensing shots with…

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Why is the vaccination rate in the U.S. stalling?

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In a recent press briefing, White House press secretary Jen Psaki touched on the flatlining COVID-19 vaccination rates in the U.S. 

Despite a series of vaccine mandates, the daily rate of new COVID-19 vaccinations is the lowest it’s been since mid-January, according to CDC data. 

Daily U.S. vaccination rates have returned dipped below 500,000 doses per day, which had been a lower threshold in July.  

“We did expect that rates of newly vaccinated would decline over time as they have in other countries with more mature vaccination programs,” Psaki said. 

Jen Psaki. Image courtesy of Wikipedia.

There have also been similar declines in vaccination rates in countries with advanced vaccination programs. Examples include the United Kingdom, Israel and Canada. “As a greater percentage of the population is vacci…

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