SWHR Comments on Cures 2.0 Legislation

SWHR provided Representative Diana DeGette (D-CO) and Representative Fred Upton (R-MI) with initial feedback today in response to their recent concept paper addressing the bipartisan planned “Cures 2.0” legislation. The concept paper addresses six key areas Rep. DeGette and Rep. Upton hope to address in follow-up legislation to 2016’s 21st Century Cures Act.

SWHR’s early feedback includes suggested language regarding sex as a biological variable (SABV) in clinical trials research and inclusion of women in research. Feedback also covered on the first section of the concept paper, entitled “National Testing and Response Strategy for Current and Future Pandemics.”

SWHR recommended upcoming Cures 2.0 legislation:

  • Include language directing NIH to provide information regarding compliance with SABV stipulations in the original 21st Century Cures Act.
  • Use NIH’s definitions of sex and gender — as outlined in the NIH SABV guidance document — to ensure appropriate implementation of the original statutory requirement.
  • Make the study of SABV a priority in federally funded research by expanding initiatives such as the NIH’s Sex & Gender Administrative Supplement Program, which grants supplemental funding as an incentive to add a sex component to an existing research program.

Additionally, SWHR asked the representatives to ensure the National Institutes of Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) have adequate authority and funding to implement recommendations related to SABV and clinical trials research.

Related to the ongoing coronavirus pandemic, SWHR recommended that upcoming legislation require states to:

  • Collect comprehensive data from patients testing positive for the disease as well as those who receive tests but test negative for the disease.
  • Track sex differences in deaths, symptoms, risk factors, and virus exposure.
  • Include information about pregnancy status and response to the virus.

Read SWHR’s Comments

SWHR provided Representative Diana DeGette (D-CO) and Representative Fred Upton (R-MI) with initial feedback today in response to their recent concept paper addressing the bipartisan planned “Cures 2.0” legislation. The concept paper addresses six key areas Rep. DeGette and Rep. Upton hope to address in follow-up legislation to 2016’s 21st Century Cures Act.

SWHR’s early feedback includes suggested language regarding sex as a biological variable (SABV) in clinical trials research and inclusion of women in research. Feedback also covered on the first section of the concept paper, entitled “National Testing and Response Strategy for Current and Future Pandemics.”

SWHR recommended upcoming Cures 2.0 legislation:

  • Include language directing NIH to provide information regarding compliance with SABV stipulations in the original 21st Century Cures Act.
  • Use NIH’s definitions of sex and gender — as outlined in the NIH SABV guidance document — to ensure appropriate implementation of the original statutory requirement.
  • Make the study of SABV a priority in federally funded research by expanding initiatives such as the NIH’s Sex & Gender Administrative Supplement Program, which grants supplemental funding as an incentive to add a sex component to an existing research program.

Additionally, SWHR asked the representatives to ensure the National Institutes of Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) have adequate authority and funding to implement recommendations related to SABV and clinical trials research.

Related to the ongoing coronavirus pandemic, SWHR recommended that upcoming legislation require states to:

  • Collect comprehensive data from patients testing positive for the disease as well as those who receive tests but test negative for the disease.
  • Track sex differences in deaths, symptoms, risk factors, and virus exposure.
  • Include information about pregnancy status and response to the virus.

Read SWHR’s Comments