
Comment: Patient Focused Drug Development: Methodologic and Other Challenges Related to Patient Experience Data
Submitted to the Food and Drug Administration and Department of Health and Human Services
Policy
In January 2025, LDI Senior Fellows Alice Abernathy, MD, MSHP, and Abigail Wilpers, PhD, WHNP-BC, co-chairs of the Maternal and Reproductive Health Working Group, submitted a public comment in response to a Proposed Rule from the U.S. Departments of the Treasury, Labor, and Health and Human Services. The proposed rule would require insurance coverage of over-the-counter (OTC) preventative items and services without a prescription by a health care provider. This comment builds on a previous comment submitted by the LDI Maternal and Reproductive Health Working Group on the same topic.
On January 15, 2025, the Proposed Rule was withdrawn.
Submitted to the Food and Drug Administration and Department of Health and Human Services
Presented to Staff from the Office of U.S. Representative Pramila Jayapal
Presented to U.S. Senator Elizabeth Warren
Presented to Members of the Pennsylvania General Assembly and Governor Shapiro’s Office
Delivered to the United States Senate Committee on Finance
Submitted to the Office of Minority Health, U.S. Department of Health and Human Services