HHS

HHS, DoD Announce $12.7M Contract to Increase COVID-19 Testing

by Samantha McGrail

HHS and the Department of Defense (DoD) jointly announced a $12.7 million contract to increase domestic production for two rapid point-of-care COVID-19 tests.  The contract is with InBios...

FDA Publishes List of Essential Medicines to Address COVID-19

by Samantha McGrail

FDA recently published a list of 223 essential medicines, medical countermeasures, critical inputs to have available at all times and serve patient needs in the appropriate dosage forms. The product...

States Detail Specific Use of Abbott’s BinaxNOW COVID-19 Tests

by Samantha McGrail

Last week, states began to report what communities they will distribute Abbott’s BinaxNOW COVID-19 test to assist ongoing reopening efforts. Back in August, the Trump Administration announced it...

Eli Lilly Strikes Deal with Govt Over COVID-19 Antibody Drug

by Samantha McGrail

HHS and the Department of Defense (DoD) recently announced an agreement with Eli Lilly and Company to purchase the first doses of the company’s COVID-19 antibody therapeutic, LY-CoV555. The...

HHS Guidance Further Expands Access to COVID-19 Vaccines, Tests

by Samantha McGrail

HHS recently issued guidance authorizing qualified pharmacy technicians and state-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines, and COVID-19 tests. The guidance,...

Hospitals Go Back to Purchasing Remdesivir from Distributor

by Samantha McGrail

HHS recently announced that American hospitals can go back to purchasing Gilead’s COVID-19 antiviral, Veklury (remdesivir), directly from the drug’s distributor starting.  Over the...

HHS to Share Best Practices for Point-of-Care COVID-19 Testing

by Samantha McGrail

HHS and The Rockefeller Foundation recently signed an agreement to identify and share effective approaches for increasing rapid point-of-care (POC) COVID-19 testing in various communities.  Under...

CDC to Dole Out $200M for COVID-19 Vaccine Preparedness

by Samantha McGrail

HHS recently announced that the CDC will provide $200 million to 64 jurisdictions for COVID-19 vaccine preparedness.   CDC will award the funding from the Coronavirus Aid, Relief, and...

FDA Finalizes Rule on Prescription Drug Importation from Canada

by Samantha McGrail

The FDA recently finalized a rule that would allow prescription drug importation from Canada in FDA-authorized programs. The final rule, part of the White House’s Safe Importation Action Plan,...

HHS, DoD Release COVID-19 Vaccine Distribution Strategy

by Samantha McGrail

HHS and the Department of Defense (DoD) released two documents Wednesday outlining the Trump Administration’s COVID-19 vaccine distribution strategy. The documents provide four necessary tasks...

HHS Issues Guidance to Expand Access to COVID-19 Vaccines

by Samantha McGrail

Last week, HHS issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to safe and effective COVID-19 vaccines when they become available.  The...

CMS Seeks Faster Medicare Coverage for Newly Approved Devices

by Samantha McGrail

Today, CMS issued a proposed rule that would create a new, accelerated Medicare coverage process for innovative products that FDA deems “breakthrough,” including new implants or gene-based...

HHS Authorizes Pharmacists to Administer Childhood Vaccines

by Samantha McGrail

HHS recently issued a third amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to lifesaving childhood vaccines during the COVID-19...

HHS, DoD Tap McKesson to Help with COVID-19 Vaccine Distribution

by Samantha McGrail

HHS and the Department of Defense (DoD) recently announced that McKesson Corporation will be a central distributor of future COVID-19 vaccines and related supplies needed to administer the drug. For...

HHS, DoD to Manufacture 100M Doses of Moderna’s COVID-19 Vaccine

by Samantha McGrail

HHS and the Department of Defense (DoD) recently announced an agreement with Moderna to manufacture and deliver 100 million doses of the company’s COVID-19 vaccine candidate. For more...

AGs Lead Charge to Increase Access, Affordability of Remdesivir

by Samantha McGrail

A bipartisan multistate coalition recently called on HHS, the National Institutes of Health (NIH), and FDA urging them to use their authority to increase the availability of remdesivir. For more...

Members of Congress Demand Transparency of Operation Warp Speed

by Samantha McGrail

Twenty-four members of Congress demand increased oversight and transparency of Operation Warp Speed vaccine development program in an official letter to HHS Secretary Alex Azar. In the letter, the...

Trump Aims to Lower Drug Prices Via PBM Reform, Drug Importation

by Samantha McGrail

The Trump administration is aiming to lower drug prices by eliminating kickbacks to middlemen, like pharmacy benefit managers (PBMs), and increasing drug importation in three new executive orders...

HHS Signs $1.95B Agreement to Produce Pfizer’s COVID-19 Vaccine

by Samantha McGrail

HHS and the Department of Defense (DoD) recently announced an agreement with Pfizer Inc. for large-scale production and nationwide delivery of 100 million doses of its COVID-19 vaccine in the US. For...

GSK, CureVac Partner to Manufacture mRNA Vaccines, Antibodies

by Samantha McGrail

GSK and CureVac recently announced a collaboration for the research, development, manufacturing, and commercialization of five mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious...