Preparedness
The Department of Homeland Security (DHS) announced more than $2 billion in funding towards 2023 preparedness and grant programs. The programs are intended to assist state, local, tribal, and territorial officials to better prepare, prevent, protect, and respond to acts of terrorism. DHS Secretary Mayorkas stated that DHS is “fulfilling a key aspect of its mission by equipping state, local, tribal, and territorial governments, as well as transportation authorities and nonprofit organizations, with vital resources to help them strengthen our nation’s preparedness.” The 2023 grant guidance will continue focusing on the nation’s highest risk areas as it is vital to strengthening the capabilities of local communities to ensure they are best positioned and to ensure the safety and security of the nation.
COVID-19 Updates
The Department of Health and Human Services (HHS) is preparing for the COVID-19 PHE to expire on May 11, 2023. The Biden Administration remains committed to addressing COVID-19 over the next few months as they transition COVID-19 policies and the current flexibilities enabled by the current PHE Declaration to ensure that COVID-19 vaccines and treatments will remain widely accessible to patients. There are significant flexibilities and actions that will not be affected. Major Medicare and Medicaid telehealth flexibilities, access to buprenorphine for opioid use disorder treatment in Opioid treatment programs, access to expanded methadone take-home doses for opioid use disorder treatment, and access to pathways for emergency use authorizations (EUA) for COVID-19 products (such as tests, vaccines, and treatments through the Food and Drug Administration (FDA)) will not be affected. Certain Medicare and Medicaid waivers and broad flexibilities for health care will end and coverage for COVID-19 testing will change. As these changes take place, the Administration will work closely with partners to ensure a seamless transition.
On February 24, the FDA issued an EUA for Lucira which is the first over-the-counter at home diagnostic test that is able to differentiate and detect Influenza A, B, and SARS-CoV-2. The Lucira COVID-19 and Flu Home Test is a single use test kit for individuals with signs and symptoms consistent with respiratory tract infections and can deliver results from self-collected nasal swab samples in around 30 minutes. A prescription is not needed to purchase the test and can be performed completely at home by individuals 14 years and older or by an adult for individuals 2 years or older. The FDA will continue to use “its authorities to increase the number of appropriately accurate and easy to use at-home tests available to the public.”
The American Association for the Advancement of Science (AAAS) has released lessons learned from the NIH-led research response to COVID-19 , as leaders from National Institutes of Health (NIH) and partner organizations outline the NIH’s COVID-19 response. Leaders reflect on crucial lessons learned that will impact and inform public health research responses to future pandemics, the importance on building diversity in clinical trials, prioritizing therapeutic trials, and streamlining the development of diagnostic tests. The article indicates that one of the most valuable lessons that COVID-19 has taught the research community is on the “importance of collective effort, the need for continuous investment in basic and applied sciences, and how to better empower trusted sources of information from local levels”. Read more on the analysis here.
As of February 8, the White House voted to end the COVID-19 vaccine requirement for foreign travelers, a requirement that has been in place since October 2021. Bill H.R. 185 restricts the entry of noncitizens who are not immigrants into the US by air travel unless they are fully vaccinated against COVID-19 or have confirmed that they will take public health measures to prevent the spread of the disease. The White House registered its opposition to the bill, stating that it would cut down the critical principle of issuing policies guided by science. As the country approaches the end of the PHE, the White House will continue to review COVID-19 policies, including foreign vaccine requirements. For updates visit Congress.gov.
Supply Chain Updates
On February 22, Illinois-based Akorn Pharmaceuticals, a pharmaceutical company that manufactures generic and branded prescription pharmaceuticals, filed for bankruptcy and announced it would cease all US operations and terminate all employees immediately. Akorn Pharmaceuticals manufactures albuterol sulfate inhalation solution, a solution that is used to reverse or prevent bronchospasm, a narrowing of the airways in the lungs that cause breathing problems usually seen in viral and bacterial infections such as bronchitis, RSV, influenza, COVID-19, asthma, COPD, emphysema, and other diseases of the lungs.
- Both the FDA and American Society of Health-System Pharmaceuticals (ASHP) have listed albuterol sulfate inhalation solutions on their drug shortage lists. Akorn Pharmaceuticals and other companies reporting production disruptions and delays include Nephron, Mylan (Viatris), and Sun Pharma. Manufacturers have not provided a specific cause explaining these shortages, however, they appear to be related to increased overall demand for jet nebulizer solutions related to a rise in respiratory illnesses across the nation and undisclosed supply chain issues.
Health Equity
According to the ‘Vital Signs’ report released by the Centers for Disease Control and Prevention (CDC), Black and Hispanic patients on dialysis have higher rates of staph bloodstream infections. The study found that adults on dialysis treatment for end-stage kidney disease were up to 100 times more likely to have a staph bloodstream infection than individuals who were not on dialysis from 2017-2020. More than half the individuals receiving dialysis in the US belong to a racial or ethnic minority, with 1 in every 3 people being Black and 1 in every 5 people being Hispanic. In order to prevent infections among patients that receive dialysis, an equitable approach to care for individuals from all racial, ethnic, and socioeconomic groups is required. For more information about this report, visit www.cdc.gov/vitalsigns.
The Biden Administration has been working to advance equity through a multitude of executive orders, administrative actions, and provisions for increased funding and resources. Agencies across the federal government have been examining policies and programs for disparities that have made things difficult for Black Americans and people with disabilities to thrive in their communities. The Administration continues to work towards equitable outcomes by focusing on areas such as apprenticeships, financial empowerment, understanding the role of Black disabled workers in the economy, promoting equitable disability determinations, identifying inequities in social security programs, and much more. For more information on how the Biden Administration is working towards more equitable outcomes, view a factsheet here.
The Biden Administration has announced their plan to advance progress on the four-part unity agenda, an agenda that specifically focuses on areas where Democrats and Republicans can come together to ensure progress for the nation’s people. The Unity agenda is supported through the Administration’s fiscal year 2023 budget through targeted investments aimed at taking on the mental health crisis, accelerating progress against cancer, delivering on the commitment to veterans, and working to combat the opioid epidemic. The Administration newly announced a set of policies that will continue advancing the four-part unity agenda to deliver change in communities across the nation. More on the factsheet here.
|
