This environmental scan, conducted by Mathematica and funded by ASPE, examines the types of direct and direct costs to patients associated with clinical trial participation. It also explores the effect of COVID-19 on costs to patients, including cost implications of clinical trial innovations widely implemented during COVID-19 and other efforts to increase diversity of clinical trials.
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 1 - 10 of 41. 10 per page. Page 1.
Advanced SearchASPE Issue Brief, Report
Transformation of the Clinical Trial Enterprise: Lessons Learned from the COVID-19 Pandemic
In 2023, ASPE launched a research project to understand the impacts of COVID-19 on the clinical trial enterprise and identify key lessons learned.
ASPE Issue Brief
Impacts of a Nonprofit Membership-Based Pharmaceutical Company on Volume of Drugs Sold and Drug Prices: A Case Study
We report findings of a case study of Civica Rx, a U.S. nonprofit pharmaceutical company whose model is based on long-term hospital membership agreements with minimum volume commitments and buffer stock requirements.
Report
The Potential Role of The Nonprofit Pharmaceutical Industry in Addressing Shortages and Increasing Access to Essential Medicines and Low-Cost Medicines
We report findings of a study that described the emerging nonprofit pharmaceutical industry and its commercialization activities to enhance access to affordable and essential drugs, or resiliency in the supply chains of medical products.
Research Summary
Premarket Notifications and Patents for Breast Pumps Before and After the ACA
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.
ASPE Data Point
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.