One of life’s certainties is that things don’t always go according to plan. SOCMA’s Bulk Pharmaceuticals Task Force (BPTF) and other industry stakeholders worked for several months to negotiate the original Generic Drug User Fee Act (GDUFA). Ideas were shared, resources were estimated, commitments were made, and finally, an act of Congress made it the law.
SOCMA’s Bulk Pharmaceuticals Task Force has long been an advocate and supporter of the Food and Drug Administration’s (FDA) Generic Drug User Fee (GDUFA) program and its goal to consistently perform risk-based inspections of both U.S. and foreign drug manufacturing facilities. But concerns were recently raised when a memo from the Department of Health and Human Services disclosed a 40 percent decrease in the number of inspections of U.S. drug facilities in 2014 and 2015 – a move that could significantly impact the generic active pharmaceutical ingredient (API) manufacturers the Task Force represents.