Legislation being considered by Congress will remove the requirement that all biologic medicines – drugs such as insulin, vaccines, cancer treatments and other therapies made using living matter – comply with public quality standards of the U.S. Pharmacopeia (USP). This same legislation would also apply to biosimilars. As a result, public confidence in biologics and biosimilars as well as patient safety would be at risk. Learn more.
For a hundred years, federal law has required that all drugs adhere to public quality standards—part of ensuring safety and protecting the public’s health. Language that would exempt biologics, including biosimilars, from adhering to the same public quality standards as other prescription medicines was recently added to the FDA and NIH Workforce Authorities Modernization Act. Learn about the potential impact this biologics quality exemption may have on competition, product development, and the public's confidence in biologics and biosimilars.
India is a prominent player in today’s global pharmaceutical arena and a major contributor to the world’s supply of medicines. A large number of generics and OTC medicines in the U.S. are imported from India, which makes USP's collaborations with Indian pharma critical.
USP's CEO Dr. Ron Piervincenzi relays his experiences and lessons learned from the 68th World Health Assembly held in Geneva, Switzerland, which he recently attended as a private advisor to the U.S. delegation led by Secretary of Health and Human Services, Sylvia Burwell.
Margaret Hamburg is approaching the end of a successful six-year tenure as Commissioner of the U.S. Food and Drug Administration. USP extends its congratulations to Dr. Hamburg in this letter from CEO Ron Piervincenzi.
Access to quality care and medicines is an integral part of public health. For USP, an organization that creates and promotes public standards for medicines and foods, quality and access are two sides of the same coin and in fact the absence of either one actually threatens effectiveness of medical care around the world.