Controversial legislative proposal threatens patient safety


Proposed legislation would remove public quality standards required for biologics

USP is urging the Senate Committee on Health, Education, Labor and Pensions (HELP) to reject a controversial provision tucked inside the “Lower Health Care Costs Act” draft that would threaten patient safety by removing the requirement that biologic medicines meet public quality standards established by USP.

This provision is opposed by prominent patient, healthcare practitioner and industry groups including the American Pharmacists Association, the American Diabetes Association and the American Cancer Society Cancer Action Network, Inc. In the last Congress, a similar proposal was rejected after robust engagement from numerous stakeholders during consideration of the 21st Century Cures Act.

Public transparent standards have led to great innovations in biologic medicines and competition in the market, and this provision would undermine that by making public standards for quality optional.

Learn more about this controversial provision at