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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 11 - 20 of 50. 10 per page. Page 2.

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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.
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.