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HHS Logo Eagle IconU.S. Department of Health and Human Services

Office of Science and Data Policy (SDP)

The Office of Science and Data Policy is the departmental focal point for policy research, analysis, evaluation, and coordination of department-wide public health science policy and data policy activities and issues. The Office provides authoritative advice and analytical support to the ASPE and departmental leadership on public health science policy and data policy issues and initiatives, coordinates science and data policy issues of interagency scope within HHS, and manages interagency initiatives in science policy and data policy. The Office works closely with staff from across the Department on strategic plan development and implementation efforts. The Offices also carries out a program of policy research, analysis, evaluation, and data development in these issues.

The Office of Science and Data Policy includes several components:

Topic Areas:

  • HHS Data Council
  • Regulatory Impact Analysis
  • Strategic Planning
  • Information Quality Guidelines
  • Prevention and wellness
  • Public health systems and functions
  • Food safety and nutrition
  • Drugs and devices
  • Tobacco control and prevention
  • Biomedical research and development
  • Economic analysis
  • Emergency preparedness, response, and recovery
  • Data and statistical policy
  • Health disparities and vulnerable populations
  • Health information technology
  • Microsimulation
  • Privacy policy

Reports

Displaying 1 - 10 of 183. 10 per page. Page 1.

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ASPE Issue Brief

An Examination of March-in Rights and Drug Products with Government-Interest Patents

March-in authority allows the federal government to grant licenses on privately owned patents for inventions developed with federal funding provided certain statutory requirements are met. It was designed to ensure that the benefits of the American taxpayers’ investment in research and development are reasonably accessible to the public.
ASPE Issue Brief

Characteristics of Part D Drugs in Shortage

In this Report, we matched a sample of Part D drugs and biological products that had price changes between January 2011 and October 2023 to FDA’s January 2023 list of drug shortages database. Then we analyzed price changes that occurred before and after the shortage, overall and by select drug characteristics of interest.
ASPE Issue Brief

Characteristics of Part B Drugs in Shortage

In this Report, we matched a sample of Part B drugs and biological products that had price changes between January 2011 and October 2023 with the FDA’s January 2023 list of drug shortages database. Then we analyzed price changes that occurred before and after the shortage, overall and by select drug characteristics of interest.
ASPE Issue Brief

Comparing U.S. and International Market Size and Average Pricing for Prescription Drugs, 2017-2022

This issue brief examines trends related to market size measured via sales revenues and volume of prescription drug use between the U.S. and other countries between 2017 and 2023. Specifically, we compare the U.S. to the rest of the world (excluding the U.S.) and the other OECD countries (excluding the U.S.).
ASPE Issue Brief

Novel Antimicrobial Drug Development and Access: U.S. Government Support and Opportunities

The pipeline and commercial market for novel antimicrobial drugs is insufficient to address current and future patient needs or mitigate the loss of effective treatments as antimicrobial resistance spreads. The U.S. Government implements a range of efforts to ensure sustainable availability of antimicrobial treatments, supporting research, product development, and appropriate use.
Report

Developing and Piloting a Federal Evaluation Approach for Complex Cross-Agency Initiatives: The Overdose Prevention Test Case

The final summary report on “Developing and Piloting a Federal Evaluation Approach for Complex Cross-Agency Initiatives: The Overdose Prevention Test Case” lays out the findings of HHS effort to test a cross-departmental methodology.
Report

Guidance on Proper Consideration of Small Entities in Rulemakings of the U.S. Department of Health and Human Services

This guidance, originally published in 2003, contains the following introduction:
ASPE Issue Brief

Participant Diversity by Race, Ethnicity, and Sex in Rare Disease Clinical Trials: A Case Study of Eight Rare Cancers

Rare cancer clinical trials appear to enroll less diverse participants than clinical trials more broadly and therefore may require additional considerations or unique solutions to diversify participant recruitment. These differences persisted within both NIH and non-NIH funded trials.
Report

Impact of Climate Change on Health and Drug Demand

It is anticipated that extreme weather events due to climate change will increase the prevalence of a number of acute and chronic diseases. As a result, the demand for drugs to prevent or treat those conditions is likely to increase.
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).