Policy Letters

As part of its advocacy mission, the Society for Women’s Health Research monitors the activities of the executive branch in the areas of women’s health and research. At the request of various federal agencies, SWHR periodically submits public comment letters detailing its positions on issues pertaining to SWHR’s public policy priorities.


  • In a letter to the HHS secretary, SWHR urged HHS to preserve the standing of the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) as a Federal Advisory Committee so it can continue its essential work advancing the participation of pregnant and lactating women in clinical trials. (July 24, 2019)
  • SWHR submitted two comment letters to the Food and Drug Administration (FDA) on its draft guidance to industry on post-approval pregnancy safety studies and on pre- or post-marketing lactation studies. (July 8, 2019)
  • SWHR provided input to the Institute for Clinical and Economic Review (ICER) on the 2020 update to its value assessment framework, recommending ways that ICER can improve its methods for working with stakeholders and better assess the value of drugs and health care interventions. (June 10, 2019)
  • SWHR sent letters to the Senate and House subcommittees that oversee National Institutes of Health (NIH) funding urging increased investment in the agency to support scientific and medical research in fiscal year (FY) 2020 federal appropriations. (April 15, 2019)
  • SWHR provided comments on HHS’ Pain Management Best Practices Inter-Agency Task Force Draft Report, highlighting the specific needs of women in relation to pain management and the importance of increased research on sex differences in pain responses. (March 29, 2019)
  • SWHR conceived a set of principles on Patient-Focused Drug Development (PFDD) to inform topics addressed in FDA’s PFDD guidance documents that have implications for women and their health. (February 21, 2019)
  • SWHR submitted comments on NICHD’s 5-year Strategic Plan to guide research on pregnancy and women’s reproductive health. (February 14, 2019)
  • In a letter to Centers for Medicare & Medicaid Services Administrator Seema Verma, SWHR expressed serious concerns with the agency’s December 2018 published guidance to the Medicare Administrative Contractors on National Coverage Determination (NCD90.2) for Next Generation Sequencing. (January 31, 2019)
  • SWHR provided information to the National Heart, Lung, and Blood Institute (NHLBI) on scientific gaps in understanding sex and gender differences in sleep disorders. (January 25, 2019)
  • SWHR wrote a letter to Sen. Tammy Duckworth and Rep. Jan Schakowsky supporting their congressional resolution recognizing January 25 as Women’s Health Research Day. (January 22, 2019)


  • SWHR provided comments to the Food and Drug Administration (FDA) on its Patient-Focused Drug Development Guidance to emphasize the importance of addressing patient population diversity, and specifically sex and gender. (December 14, 2018)
  • SWHR sent a letter to the Centers for Medicare & Medicaid Services expressing concerns about its recent memorandum that allows Medicare Advantage plans to implement step therapy protocols to manage Part B-covered medications. (Oct. 5, 2018)
  • SWHR signed on to a congressional letter expressing appreciation for FDA’s detailed technical assistance on discussion draft legislation. (August 8, 2018)
  • SWHR submitted comments to the FDA on its draft guidance on including pregnant women in clinical trials. (June 8, 2018)
  • SWHR submitted comments to the Institute for Clinical and Economic Review (ICER) on its draft evidence report on new therapies for endometriosis. (May 31, 2018)
  • SWHR signed on to a letter urging Congress to enact legislation to modernize oversight of clinical laboratory diagnostics. (May 9, 2018)
  • SWHR submitted comments to ICER on its evaluation of calcitonin gene-related peptide (CGRP) inhibitors, a new class of preventive therapies for episodic and chronic migraine. (May 8, 2018)
  • SWHR issued comments to the Food and Drug Administration on Patient-Focused Drug Development. (February 16, 2018)
  • SWHR  Input on ICER 2018 Review of Endometriosis as Public Comment. (February 1, 2018)
  • SWHR is pleased to support the congressional resolution recognizing January 25 as Women’s Health Research Day. (January 19, 2018) 


View Past Policy Letters

Policy Briefings

SWHR regularly holds briefings on a variety of women’s health and research-related subjects. These briefings are attended by Congressional staff, federal agency personnel, advocacy group representatives and others to educate attendees about issues important to women’s health.

U.S. Presidential Election Letters

SWHR sent a letter congratulating the 2016 presidential election winner.

SWHR sent letters congratulating the 2016 presidential election nominees and urging them to make women’s health a priority in their platforms.

Congressional Testimony

As the thought leader in advocating for research on sex differences, SWHR is often called upon by Congressional Committees to offer expert testimony on a variety of subject areas. An archive of our past Congressional Testimony is below.

Written Testimony for Federal Funding

Commentary Letters