Advocating for quality

Harnessing a broad coalition of diverse partners, USP advocates in the US and around the world for public policies that support the public health safety net.

From our work with partners raising awareness of the impact of quality, to generating evidence that can inform effective policymaking, to elevating the use of public quality standards as critical tools to advance worldwide progress on health priorities, USP uses our voice to help build a stronger public health safety net.


Generating data to inform policymaking on medicine quality

“This year, USP launched the USP Quality Institute, a new research and advocacy initiative developing evidence to support policy decisions related to medicines quality. In the past year, we have established two academic partners, at Georgetown and Boston Universities, and fellows have begun their first research projects. These initial fellows are focused on demonstrating how poor-quality antimicrobials can create or accelerate resistance to important treatments such as antibiotics and antimalarials. In the coming months, we also will announce new academic partnerships and additional investigational thematic areas, expanding our efforts to develop an evidence base for why quality medicines matter.”

Fouad Atouf
Anthony Lakavage, JD
Senior Vice President, External Affairs
protecting quality of inactive ingredients

Supporting FDA’s efforts to encourage new generics

“USP has a long history of developing quality standards that help more generic medicines get to the market. In 2017, the FDA began directing applicants for FDA approval of new generic medicines to reach out directly to USP to resolve any potential issues complying with USP quality standards. Through this ’Pending Monograph Program,’ USP facilitates new generics entering the market by accelerating revisions to existing USP monographs to ensure they include the applicants’ specifications for their product. This helps ensure these new generics are in compliance with USP quality standards so they can be legally marketed in the US.”

Elizabeth Miller
Elizabeth Miller, Pharm.D.
Vice President, U.S. Regulatory Affairs