Statement from Acting FDA Commissioner Ned Sharpless, M.D., on continued progress enhancing patient access to high-quality, low-cost generic drugs

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on continued progress enhancing patient access to high-quality, low-cost generic drugs

FDA generic drug approvals reach record high in fiscal year 2019

Affordable access to medicines is a public health concern and more generic drug competition can help reduce prices, improve access and benefit the public health. Safe, effective and high-quality generic drugs play a vital role in our health care system. Generic drugs account for about 90% of all prescription drug purchases in the U.S. In 2018, competition from generic drugs saved the health care system about $293 billion Thanks to the FDA’s ongoing efforts under the Drug Competition Action Plan and the Generic Drug User Fee Amendments, the FDA has built a thriving generic drug program that continues to impress me. I am pleased to report that our generic drug program is having another strong year. While we expect to see highs and lows in our approval numbers from month to month based in part on what is submitted to us for ...

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