HHS

HHS Releases New Actions to Expand COVID-19 Testing Across the US

by Samantha McGrail

HHS recently announced new actions to expand COVID-19 testing capacity across the US as part of President Joe Biden’s National Strategy for the COVID-19 Response and Pandemic Preparedness. The...

PhRMA Challenges 340B Drug Pricing Program ADR Rule

by Samantha McGrail

The Pharmaceutical Research and Manufacturers of America (PhRMA) recently filed a complaint stating that the 340B Drug Pricing Program administrative dispute resolution (ADR) rule is “arbitrary...

HHS Expands Workforce Authorized to Administer COVID-19 Vaccines

by Samantha McGrail

HHS recently issued a fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to add categories of qualified persons authorized to prescribe,...

Biden’s Executive Order on Expanding Access to COVID-19 Therapies

by Samantha McGrail

President Joe Biden recently signed an executive order to accelerate the development of novel COVID-19 therapies and improve access to care for all Americans.  First, Biden called on the HHS and...

US to Remain WHO Member, Join Global COVID-19 Vaccine Program

by Samantha McGrail

The US will remain a member of the World Health Organization (WHO) under President Joe Biden and will join COVAX, a global COVID-19 vaccine program led by WHO, NIAID Director Anthony Fauci, MD, said in...

Janet Woodcock Acting FDA Commissioner After Hanh’s Departure

by Samantha McGrail

Janet Woodcock will be stepping in as Acting FDA Commissioner while the Biden administration finalizes a nominee for the position. Woodcock will replace Stephen M. Hahn, MD, after he resigned last...

HHS Expands Access to Buprenorphine for Opioid Use Disorder

by Samantha McGrail

HHS recently announced that it will expand access to medication-assisted treatment (MAT) for opioid use disorder. Under the agency’s guidelines, Practice Guidelines for the Administration for...

HHS Buys 1.25M More Doses of Regeneron’s COVID-19 Antibody Cocktail

by Samantha McGrail

Roche recently announced that HHS and the Department of Defense (DoD) will purchase additional doses of Regeneron’s COVID-19 antibody cocktail, casirivimab and imdevimab. Under the agreement,...

HHS Distributes $22B to States for COVID-19 Testing, Vaccinations

by Samantha McGrail

HHS recently announced that it will provide more than $22 billion in funding to states, localities, and territories to support COVID-19 testing and vaccination.  Over $19 billion of the funding,...

Moderna Ups COVID-19 Vaccine Manufacturing Estimate to 600M in 2021

by Samantha McGrail

Moderna recently released a COVID-19 vaccine manufacturing update for its mRNA-based vaccine, mRNA-1273. The company announced that it is increasing its base-case global production estimate from 500 to...

HHS Unveils 3-Part Plan for Supporting COVID-19 Testing Efforts

by Samantha McGrail

HHS recently announced three ways the federal government will continue to support COVID-19 testing efforts by states and authorities into 2021.  The initiative builds upon over $31 billion in...

HHS Doles Out Additional $227M for COVID-19 Vaccine Preparedness

by Samantha McGrail

HHS recently announced that the CDC will award an additional $227 million for COVID-19 vaccine preparedness and response activities. Specifically, $140 million will be used for vaccine preparedness...

FDA Issues EUA for Abbott’s At-Home COVID-19 Antigen Test

by Samantha McGrail

FDA recently issued an emergency use authorization (EUA) for Abbott’s COVID-19 antigen test, the BinaxNOW COVID-19 Ag Card Home Test, for use by patients with a prescription.  The test is...

Pharma Organizations Sue HHS Over Most Favored Nation Drug Rule

by Samantha McGrail

UPDATE 12/23/2020: Judge Blake of the US District Court for the District of Maryland has granted a temporary restraining order on the Most Favored Nation rule. Top pharmaceutical organizations...

HHS Ensures Access to COVID-19 Vaccines for Tribal Health Programs

by Samantha McGrail

HHS recently announced that all tribal health programs and Urban Indian Organizations (UIOs) have chosen their preferred method for receiving a COVID-19 vaccine. Tribal health programs and UIOs have...

HHS, DoD to Increase Domestic Swab Production for COVID-19 Tests

by Samantha McGrail

HHS and the Department of Defense (DoD) recently awarded an $11.6 million contract to Puritan Medical Products Company, LLC to boost domestic production of nasal swabs used for COVID-19 tests. The...

HHS to Allocate Doses of Regeneron’s COVID-19 Antibody Therapy

by Samantha McGrail

HHS recently announced that it will allocate initial doses of Regeneron’s investigational monoclonal COVID-19 antibody therapy immediately. Weekly allocations to state and territorial health...

Trump Issues New Rules to Lower Prescription Drug Pricing

by Samantha McGrail

President Trump recently issued two regulations to lower prescription drug pricing through a slew of new initiatives at aim prescription drug spending in Medicare.  The reforms are the direct...

HHS Partners with Pharmacies to Boost Access to COVID-19 Vaccines

by Samantha McGrail

HHS recently announced the government’s partnerships with large chain pharmacies and networks to boost access to COVID-19 vaccines across the US. The partnership program will cover nearly 60...

HHS Buys 300K Doses of Eli Lilly’s COVID-19 Antibody Treatment

by Samantha McGrail

HHS announced that will allocate initial doses of Eli Lilly & Company’s COVID-19 antibody treatment after it recently received emergency use authorization from the FDA.  At the end of...