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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 37. 10 per page. Page 2.

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Report

Understanding Coverage Considerations for COVID-19 Vaccines and Treatments

Understanding Coverage Considerations for COVID-19 Vaccines and Treatments (Updated May 2023)
Research Summary

Optimizing Clinical Guidelines to Address Antimicrobial-Resistant Infections: A Conceptual Framework Reflecting Stakeholder Perspectives

Objectives: Clinical guidelines or guidance is an important tool for preventing and treating antimicrobial-resistant (AMR) infections. We sought to understand and support the effective use of guidelines and guidance for AMR infections.
ASPE Issue Brief

FDA User Fees: Examining Changes in Medical Product Development and Economic Benefits

This issue brief provides a primer on FDA user fees, presents findings of how user fees affect the cost of medical product development, and summarizes the research literature on user fees, most notably in expediting medical product development and approval.
ASPE Issue Brief

COVID-19 Vaccine Hesitancy and Reasons for Hesitancy Among Essential and Non-Essential Workers

Using 2021-2022 survey data from the U.S. Census Bureau’s Household Pulse Survey, this ASPE Research Report examined sociodemographic factors and trends in vaccine hesitancy among workers based on the likelihood of exposure risk to SARS-CoV-2. We classified work setting into three categories: essential healthcare, essential non-healthcare, and non-essential.
ASPE Issue Brief

COVID-19 Antivirals Utilization: Geographic and Demographic Patterns of Treatment in 2022

This report examines the utilization of oral antiviral medications, Paxlovid and Lagevrio, for the treatment of COVID-19. The analyses include an examination of time trends of COVID-19 antiviral use as well as breakdowns by age cohorts and gender. The report finds that utilization in the U.S.
Report to Congress

Report to Congress on the Affordability of Insulin

This Report to Congress examines the critical role that insulin plays in the treatment of diabetes, reviews evidence on how insulin affordability affects adherence to insulin treatment and affects downstream health consequences, and describes policy efforts to improve the affordability of insulin.
Research Summary

Characteristics of Medical Device Shortages in the US, 2006-20

Shortages of critical medical devices during the COVID-19 pandemic exposed vulnerabilities in device markets. From 2010 to 2019 there were approximately five shortages annually, but that number increased fourfold in the first half of 2020.

Therapeutic Complex Medical Device Development

This report quantified the potential impacts of select clinical strategies on the cost, duration, and phase transition probability associated with therapeutic complex medical device development stages. The model used data from a variety of sources (public and non-public) and widely accepted economic methods.
Report

Evaluating the Potential Impacts of Different Clinical Trial Strategies on Drug, Preventive Vaccine, and Therapeutic Complex Medical Device Development

This environmental scan, conducted from September 2016 – September 2021, examines the potential impacts of select strategies on the cost, duration, and phase transition probability associated with drug, preventive vaccine, and therapeutic complex medical device development stages.
ASPE Issue Brief

Estimated Cost of Developing a Therapeutic Complex Medical Device in the US

This document presents the abstract of this paper, as published in JAMA Network Open. The full text of the article is available at: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2796179 Related Products: