FDA Commissioner Stresses Need for Collaboration With USP on Monographs

May 13, 2010 12:17 pm

Margaret Hamburg, MD, commissioner of food and drugs, stressed the importance of collaboration between FDA and United States Pharmacopeia (USP) to proactively protect public health in a speech delivered at the USP convention on April 23, 2010. Hamburg emphasized that updating monographs, starting with identifying drug ingredients and products that need an up-to-date monograph, is a high priority task that will protect public health. She referenced the collaboration that took place to address the heparin contamination situation in 2008, and stated that this action "can be used as a model for how to move forward proactively to modify monographs in a way that they identify counterfeited or intentionally adulterated products…before they enter the healthcare system." Hamburg noted that such collaboration will help FDA and USP establish standards that will prevent public health crises. She also briefly described three future initiatives that will "expand efforts to promote the purity, quality and efficacy of current and new drugs" under an agreement between USP and the FDA Office of Regulatory Affairs.