Development of novel antimicrobials has slowed, and the preclinical and clinical pipeline is likely to be insufficient to support current and future patient needs.
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
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Inflation Reduction Act Research Series: Understanding Development and Trends in Utilization and Spending for Drugs Selected Under the Medicare Drug Price Negotiation Program
The Inflation Reduction Act (IRA) authorizes the Secretary of the Department of Health and Human Services (HHS) to negotiate prices directly with participating manufacturers for selected drugs that are high expenditure, single source drugs without generic or biosimilar competition.
Report
Analysis of Market Challenges for Antimicrobial Drug Development in the United States
The market for antimicrobial (AM) drugs is unique in that it is associated with a positive externality (public health) as well as a negative externality (antimicrobial resistance, or AMR) (Mossialos, et al., 2010). AMR occurs when microbes change over time and no longer respond to available medicine.
Report
Antimicrobial Drugs - Burden of Antimicrobial Resistance
It is well known that antimicrobial resistance (AMR) creates a substantial and ongoing public health and economic burden and understanding the size and nature of this burden is important for the ability to respond to the threat of AMR. However, estimating or projecting that burden within the U.S.
Report
Antimicrobial Drugs - Market Returns Analysis
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.
Report
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.