Science Policy

PMC advises policymakers about scientific principles that can help guide public policies related to personalized medicine.

SCIENCE POLICY TOPICS

  • Comparative Effectiveness Research

    PMC advises lawmakers and government officials on the relationship between comparative effectiveness research (CER) and personalized medicine. Like personalized medicine, the goal of CER is to support evidence-based decisions for optimal patient care. PMC’s report titled Comparative Effectiveness Research and Personalized Medicine: From Contradiction to Synergy helped define thinking about the two subjects as CER emerged as a major theme in health care in 2009.

  • Consumer Genomics

    PMC helps educate patients and policymakers about scientific principles that can be useful in understanding the strengths and limitations of genetic health testing. In 2019, PMC published a Consumer’s Guide to Genetic Health Testing that describes what genetic tests are, outlines the types of information the tests can provide, and explains what patients should consider before ordering an at-home genetic test directly from a genetic testing company.

  • Next-Generation Sequencing

    PMC advises regulatory and reimbursement officials on the scientific principles underpinning next-generation sequencing (NGS)-based tests, which are capable of examining millions of DNA variants at a time. Between 2018 and 2019, PMC comment letters helped prompt the Centers for Medicare and Medicaid Services (CMS) to reconsider its policies related to coverage of NGS-based testing for Medicare patients with advanced cancers.

SCIENCE POLICY WORK PRODUCTS

You can use the search bar provided below to browse PMC’s Science Policy work by topic area.

Support for Swift Senate Confirmation of Dr. Monica Bertagnolli to Lead the United States National Institutes of Health

Using Personalized Medicine to Improve Outcomes and Reduce Spending: A Letter to the House Budget Committee Health Care Task Force

FDA Guidance on Pharmacogenomic Data Submissions

National Government Services' Proposed Local Coverage Determination on Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms

Proposed Changes to NCQA's Colorectal Cancer Screening Measure

A Consumer’s Guide to Genetic Health Testing

FDA's Oversight of Development and Labeling for In Vitro Companion Diagnostic Devices in Oncology

FDA's Oversight of Gene Therapies

Personalized Medicine and Value Assessment Frameworks: Context, Considerations, and Next Steps

European Medicines Agency's 2017 Concept Paper on Predictive Biomarker-Based Assay Development