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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 1 - 10 of 57. 10 per page. Page 1.

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Research Brief

Estimating Emergency Department Utilization of Select Drugs during Extreme Heat Events

We modeled the excess utilization of three commonly used drugs that treat heat-related illness in emergency departments during extreme heat events, using literature-derived estimates of emergency department visit rates for heat-related illness on extreme heat days and drug utilization rates from medical claims data.We estimate that extreme heat is associated with an average of 34,
Report

Defining and Measuring the Resilience, Criticality, and Vulnerability of Medical Product Supply Chains

Recent disruptions in medical product supply chains have highlighted the need for stronger, more coordinated approaches to ensuring reliable access to medical products.
ASPE Issue Brief

Measuring Innovation of Medical Products

Increasing innovation in medical products is a policy priority. A first step to understanding changes in the level of innovation is to determine how to measure the baseline of innovation. Existing research employs a variety of measurement methods–scientific, therapeutic, and economic measures–to study trends in medical product (e.g., drugs, biologics, devices) innovation.
Report

Understanding the Role of Patient Advocacy Organizations in Funding Medical Product Research and Development

Patient advocacy organizations (PAOs) play a key role in medical product development. Many PAOs raise money to fund medical product development activities – such as basic science research, preclinical research, and clinical trials - for their condition of focus, whereas others fund or develop resources such as biobanks or patient registries to support the research community.
Report

U.S. Biosimilar Market Entry Challenges and Facilitating Factors

There is ongoing interest in understanding ways to reduce drug prices and improve patient access to prescription drugs in the U.S. The estimated savings to the U.S. healthcare system from the use of biosimilars are significant.
ASPE Issue Brief

Use of Participant Compensation in U.S. Clinical Research Studies

Providing compensation to clinical research participants to offset the costs associated with participation is often suggested as a way to improve recruitment and retention. However, relatively little is known about the landscape of compensation in clinical research.
ASPE Issue Brief

Empowering Patients to Participate in Clinical Trials

Increasing patient engagement in clinical trials offers opportunities to improve enrollment and retention in clinical trials, helping ensure interventions can be evaluated effectively and that clinical research dollars are used efficiently.
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.
ASPE 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.