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.
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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Advanced SearchASPE Issue Brief
Understanding the Impact and Costs Associated with Medical Device Shortages During the COVID-19 Pandemic on Providers, Health Systems, Patients, and Manufacturers
We conducted a landscape analysis to understand the characteristics, impacts, and costs associated with medical device shortages during the COVID-19 pandemic in the U.S. Among health systems, nursing homes and rural hospitals were the most impacted by medical device shortages due to high demand and supply transportation issues.
Report
Profit Margins of Pharmaceutical Supply Chain Entities on Provider-Administered Drugs in Outpatient and Physician Settings
The U.S. supply chain for provider-administered outpatient drugs involves several entities, including drug manufacturers, wholesalers, healthcare providers (e.g., outpatient facilities, hospital pharmacies, doctor’s offices, and standalone clinics), group purchasing organizations (GPOs), payers, and beneficiaries.
Report
Mergers and Acquisitions in Pharmaceutical Markets
This study, commissioned by ASPE, uses multiple data sources to 1) assess trends in pharmaceutical mergers and acquisitions (M&As) over the 2010-2023 period; 2) evaluate characteristics of drugs involved in M&As, and 3) examine the effects of M&As on the pharmaceutical supply chain.
Report
Analysis of Drug Shortages, 2018-2023
The report, "Analysis of Drug Shortages, 2018-2023" provides additional information on the data, methods, and findings. Below are the key findings.KEY POINTS
Report
Pharmaceutical Supply Chain Intermediary Margins in the Retail Channel
The U.S. supply chain for prescription drugs is highly complex, involving several intermediaries between drug manufacturers and patients. This analysis estimates the percentages of drug expenditures that are allocated to each stakeholder in the supply chain, including manufacturers.
ASPE Issue Brief, Report
New Estimates of the Cost of Preventive Vaccine Development and Potential Implications from the COVID-19 Pandemic
The ASPE issue brief examines the research and development cost and duration associated with bringing novel vaccines to the U.S. market. The results indicate that bringing a novel vaccine to the U.S. market costs an estimated $886.8 million on average, and its development process lasts 10 years.
Report
Drug Development
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).
Report
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.