Dear Dr. Hamburg:
On behalf of the members, leadership and staff of the United States Pharmacopeial Convention (USP), it is my pleasure to thank you for your tremendous leadership of nearly six years at the United States Food and Drug Administration (FDA).
Your tenure at the Agency marked a period of rapid change in medical science when our nation contended with great public health challenges and issues. Your guidance of the Agency allowed for strong regulatory action, innovative approaches to address unmet needs, and increased global ability to ensure a safe medicines environment in the United States and abroad.
In your remarks to the 2010 USP Convention, you related the feeling that you were addressing “old friends.” We reciprocate the sentiment and appreciate your efforts to strengthen the longstanding FDA-USP relationship. We are privileged to work with over one hundred FDA liaisons to our expert committees and countless other FDA scientists who dedicate themselves to food and drug safety.
Notable areas in which FDA and USP closely collaborate, and which have expanded during your tenure, include continuously modernizing USP monographs—a high priority under USP’s newly-adopted Strategic Plan; addressing food safety, including intentional adulteration of food ingredients; confronting critical public health challenges such as the melamine, heparin, and compounding incidents; addressing the increased globalization of the supply chain, including counterfeit and substandard drugs; and advancing nomenclature, safety, and labeling issues.
Major legislation and fee bills—including the Biologics Price Competition and Innovation Act (2010); the Food Safety Modernization Act (2011); the Food and Drug Administration Safety and Innovation Act (2012); the Generic Drug User Fee Amendments (2012); and the Drug Quality and Security Act (2013)—have helped secure consumers’ and patients’ access to safe and affordable medicines and foods.
The Agency truly has achieved much under your leadership, and we are pleased with the increasingly strong interactions between our two organizations, which share so much common history in support of public health. As you prepare to engage in new endeavors, we all wish you the best. We hope our paths will cross again and we will have opportunities to renew “old friendships.”
Ronald T. Piervincenzi, Ph.D.
Chief Executive Officer