Generic Drug Industry Challenges Aired

At the 4/10 GDUFA 2 quarterly implementation meeting, industry representatives discussed challenges facing the generic drugs industry, including threats to sustainable competition and drug shortages. The industry representatives noted that drug shortages within the generic market may also occur due to the consolidation of buyers and discussed the market impact that could come from proposed U.S. tariffs on China. Industry also said that proposed opioid legislation and the mandate for packaging changes could be costly to the industry.

FDA updated the process for communication and coordination about industry classifications in a timely, meaningful, way with accurate inspection results.

Additional industry topics for discussion included elements in the GDUFA 1 commitment letter such as complete response letters, complex products, earliest possible approval date, and continuous manufacturing and generics.