The cost of bringing a medical product to the U.S. market has been increasing and clinical trials constitute a large portion of these costs. In drug development, the clinical phase lasts an average of around 95 months compared to 31 months for the non-clinical phase and accounts for 69 percent of overall R&D costs (DiMasi, et al., 2016).
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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National Action Plan for Combating Antibiotic-Resistant Bacteria Progress Report: Fiscal Year 2022
The evolution of pathogens to resist the drugs used to treat infections is 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.
Environmental Scan
Impact of COVID-19 on Clinical Trials Costs to Patients
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.
ASPE 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.Related Products:
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
Costs of Drug Development and Research and Development Intensity in the US, 2000-2018
This landing page represents the abstract of a paper published in JAMA. The full text of the article is available at: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820562.Abstract
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.