In 2017, at least 2.8 million people in the U.S. acquired serious infections with bacteria that are resistant to one or more antimicrobial drugs and 35,000 have died as a result. Resistance to antimicrobials is viewed as a global threat with antimicrobial drug use in human and animal health driving resistance.
Division of Science and Public Health Policy
The Division of Science and Public Health Policy is the ASPE lead on public health and biomedical science issues and initiatives, including programmatic and policy areas that involve complex or rapidly evolving science and technology. The Division provides technical assistance on regulatory impact analysis development to HHS agencies and offices. The Division is responsible for policy coordination; long-range planning; legislative development; economic, program, and regulatory analysis; and evaluation focused on the HHS science and public health agencies – the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), National Institutes of Health (NIH), and Office of the Assistant Secretary for Preparedness and Response (ASPR). Examples of issue areas include:
- Biomedical innovation
- Biomedical research policy
- Medical product regulation
- Drug development, safety, availability, and pricing
- Public health and emergency preparedness, response, and recovery
- Opioid epidemic response
- Emerging infectious diseases
- Prevention of chronic diseases
- Food safety
Reports
Displaying 21 - 30 of 50. 10 per page. Page 3.
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National Action Plan for Combating Antibiotic-Resistant Bacteria Progress Report: Fiscal Year 2021
Pathogens that have evolved to be resistant to the drugs currently used to treat infections are an ongoing threat to public health, animal health, food production, and national security. Globally, a recent analysis estimated that 1.2 million deaths were caused by antibiotic-resistant (AR) bacteria in 2019, making this threat a leading cause of death for people of all ages worldwide.
Report to Congress
ASPE Report to Congress: Impact of Drug Shortages on Consumer Costs
Prescription drug shortages are an ongoing concern in the United States (U.S.). While prior analyses explore the frequency of drug shortages in the U.S., little is known about the extent to which U.S. shortages impact consumer costs and healthcare systems. Drug shortages impact consumer costs in various ways.
Report
Understanding Coverage Considerations for COVID-19 Vaccines and Treatments
Understanding Coverage Considerations for COVID-19 Vaccines and Treatments (Updated May 2023)
Research Summary
Optimizing Clinical Guidelines to Address Antimicrobial-Resistant Infections: A Conceptual Framework Reflecting Stakeholder Perspectives
Objectives: Clinical guidelines or guidance is an important tool for preventing and treating antimicrobial-resistant (AMR) infections. We sought to understand and support the effective use of guidelines and guidance for AMR infections.
ASPE Issue Brief
FDA User Fees: Examining Changes in Medical Product Development and Economic Benefits
This issue brief provides a primer on FDA user fees, presents findings of how user fees affect the cost of medical product development, and summarizes the research literature on user fees, most notably in expediting medical product development and approval.Related Products:
ASPE Issue Brief
COVID-19 Vaccine Hesitancy and Reasons for Hesitancy Among Essential and Non-Essential Workers
Using 2021-2022 survey data from the U.S. Census Bureau’s Household Pulse Survey, this ASPE Research Report examined sociodemographic factors and trends in vaccine hesitancy among workers based on the likelihood of exposure risk to SARS-CoV-2. We classified work setting into three categories: essential healthcare, essential non-healthcare, and non-essential.
ASPE Issue Brief
COVID-19 Antivirals Utilization: Geographic and Demographic Patterns of Treatment in 2022
This report examines the utilization of oral antiviral medications, Paxlovid and Lagevrio, for the treatment of COVID-19. The analyses include an examination of time trends of COVID-19 antiviral use as well as breakdowns by age cohorts and sex. The report finds that utilization in the U.S.
Report to Congress
Report to Congress on the Affordability of Insulin
This Report to Congress examines the critical role that insulin plays in the treatment of diabetes, reviews evidence on how insulin affordability affects adherence to insulin treatment and affects downstream health consequences, and describes policy efforts to improve the affordability of insulin.
Research Summary
Characteristics of Medical Device Shortages in the US, 2006-20
Shortages of critical medical devices during the COVID-19 pandemic exposed vulnerabilities in device markets. From 2010 to 2019 there were approximately five shortages annually, but that number increased fourfold in the first half of 2020.