This study investigated whether ACA policies to increase access to breast pumps and lactation care were associated with innovation in the market for breast pumps.
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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HHS Standard Values for Regulatory Analysis
The U.S. Department of Health and Human Services (HHS) analyzes the benefits, costs, and other impacts of significant proposed and final rulemakings, consistent with the requirements of several executive orders and statutes. HHS develops these analyses according to technical guidance published by the U.S.
Report
Competition in Prescription Drug Markets, 2017-2022
The cornerstone of a well-functioning market is competition. President Biden’s Executive Order 14036, “Promoting Competition in the American Economy” identified a lack of competition as a key driver for problems across economic sectors.
ASPE Issue Brief
Understanding Markets for Antimicrobial Drugs
Development of novel antimicrobials has slowed, and the preclinical and clinical pipeline is likely to be insufficient to support current and future patient needs.
Fact Sheet, Report
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.