With the Obama administration’s renewed national focus on protecting public health, the U.S. Pharmacopeial (USP) Convention has offered its scientific expertise and a series of recommendations to Tom Daschle, secretary-designate of the Department of Health and Human Services (HHS) and Frank Torti, M.D., MPH, acting commissioner of the Food and Drug Administration (FDA). USP is a private, non-profit public health organization that sets public standards to help ensure the quality, safety and benefit of medicines and foods worldwide. Under the 1938 Food, Drug and Cosmetic Act, prescription and over-the-counter medicines sold in the United States must comply with quality standards published in USP’s book of standards, the United States Pharmacopeia. In separate letters to Mr. Daschle and Dr. Torti, Roger L. Williams, M.D., USP’s chief executive officer, outlined the areas in which USP can offer scientific support and expertise as the new administration explores ways to better secure the nation’s supplies of medicines and foods. “President Obama has made a welcome commitment to science in many areas, and reinforcing the safety nets that help ensure the quality of medicines and food ingredients must be a priority,” said Dr. Williams. “At a time when global economic pressures may increase the risk of adulteration of drugs or foods for economic gain, as seen recently with heparin, glycerin and melamine, the need for rigorous standards and practices is more urgent than ever. Consumers and patients depend on FDA to enforce USP’s standards. USP, with its internationally recognized scientific expertise, can be important resources for HHS and FDA in this shared public health mission.” Among USP’s recommendations to HHS and FDA are sufficient funding for FDA; expanded use of quality standards in drug and food quality; greater international regulatory outreach; conserving FDA resources through use of resources such as USP’s verification programs; and promoting harmonization among international bodies that set quality standards. The letters to Mr. Daschle and Dr. Torti, along with the complete list of observations and recommendations, are at www.usp.org .
