HHS

HHS and Pfizer Reach Paxlovid Agreement to Improve Access

October 18, 2023 - Last week, the United States Department of Health and Human Services (HHS) announced that it had negotiated an agreement with Pfizer Inc. to bolster access to Paxlovid as it enters the commercial market next month. Paxlovid, nirmatrelvir packaged with ritonavir, is an antiviral drug used to manage COVID-19 in patients with mild to moderate...

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DEA Extends Telemedicine Prescription of Controlled Medicines

by Veronica Salib

In an announcement on October 6, 2023, the United States Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) announced that they would extend the COVID-19...

CDC Recommends Updated COVID-19 Boosters This Fall/Winter

by Veronica Salib

Yesterday, the United States Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) met to discuss updated COVID-19 booster recommendations for the...

HHS Petitions DEA to Reclassify Cannabis as a Schedule III Drug

by Veronica Salib

On August 30, 2023, a leaked document revealed that the United States Department of Health and Human Services (HHS) plans to petition the Drug Enforcement Administration (DEA) to reclassify cannabis...

Older and Immunocompromised Adults Advised to Get RSV Vaccine

by Veronica Salib

The Centers for Disease Control and Prevention (CDC) advised older and immunocompromised adults in the United States to get the newly available respiratory syncytial virus (RSV) vaccine. The CDC...

GSK Receives Fast Track from FDA for Gonorrhea Vaccine

by Hayden Schmidt

On Thursday, the FDA announced that it would grant GSK a fast track designation for its gonorrhea vaccine. The fast track process expedites the review process for drugs used to treat serious conditions...

Project NextGen Leverages $5 Billion for COVID Vaccine Development

by Hayden Schmidt

This week federal officials announced the $5 billion successor to Operation Warp Speed, dubbed Project Next Gen. The program will seek to address the growing threat of coronaviruses and the possibility...

HHS Releases National Cancer Plan to Further Cancer Moonshot

by Veronica Salib

On April 3, 2023, the United States HHS released detailed information for a National Cancer Plan. The plan aims to facilitate the Cancer Moonshot initiative. The Biden administration reignited the...

HRSA Announces Plans to Overhaul Organ Procurement Transplant Network

by Veronica Salib

On March 22, 2023, the United States Health Resources and Services Administration (HRSA), a subset of the HHS, announced plans to overhaul the Organ Procurement and Transplant Network (OPTN). Recently,...

Unpacking the 340B Drug Pricing Program, Its Impact on the Pharmaceutical Industry

by Veronica Salib

The 340B Drug Pricing Program has evolved significantly since its establishment in 1992. According to an article published by the Commonwealth Fund, the 340B Program is a federal drug pricing program that allows certain hospitals, clinics,...

President Biden Calls for Reform on Marijuana Regulation

by Veronica Salib

For many minority communities, marijuana possession and use can lead to years of incarceration for nonviolent offenses. The Biden administration has recognized that the harsh punishment around...

HHS Statement on FDA Approval of Bavarian Nordic Monkeypox Vaccine

by Veronica Salib

On Saturday, July 23, 2022, the director-general of the WHO declared monkeypox a public health crisis. Public health organizations have encouraged vaccination for at-risk populations to minimize the...

HHS Issues Pharmacies’ Obligation to Ensure Access to Reproductive Care

by Veronica Salib

The overturning of Roe v. Wade by the United States Supreme Court has left many people anxious about access to reproductive healthcare. Earlier this week, the HHS established guidelines for retail...

FDA Recommends Emergency Use for Novavax Coronavirus Vaccine

by Hayden Schmidt

The FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted 21­­­­­ to 0 in favor of recommending the Novavax coronavirus vaccine for emergency...

FDA Considers New Strategy to Boost Safe Opioid Disposal

by Samantha McGrail

FDA is seeking public comment on a potential change that would require opioid analgesics used in outpatient settings to be dispensed with prepaid mail-back envelopes and that pharmacies provide patient...

President Biden Nominates Former FDA Commissioner as Head of FDA

by Samantha McGrail

President Joe Biden recently nominated Robert Califf as head of FDA, according to multiple news sources. Califf previously served as FDA commissioner at the end of the Obama administration from 2016...

Biden Administration Unveils Plan to Lower Prescription Drug Prices

by Samantha McGrail

HHS Secretary Xavier Becerra recently released a comprehensive plan to lower prescription drug prices. The Drug Pricing Plan, part of a broader initiative from Joe Biden’s Executive Order on...

Health Officials Say Myocarditis After COVID-19 Vaccination “Rare”

by Samantha McGrail

Federal health officials recently added new clinical guidance on the potential for myocarditis after COVID-19 vaccination for adolescents and young adults.  The statement, signed by the leaders...

Biden Pushes Policy Changes to Protect Pharmaceutical Supply Chain

by Samantha McGrail

The White House, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), and FDA recently released policy recommendations to protect US pharmaceutical supply chains.  The...

HHS, DoD Buy 100M More Doses of Moderna, Pfizer COVID-19 Vaccines

by Samantha McGrail

HHS and the Department of Defense (DoD) recently purchased an additional 100 million doses of COVID-19 vaccines from both Pfizer and Moderna to boost vaccine supply in the US. The recent order brings...

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