US FDA generic drug approvals reach record high in fiscal year 2019

On Wednesday, the US Food and Drug Administration announced that, in fiscal year 2019, the agency approved a total of 1,171 generic drugs, an all-time record, following a record 971 approvals in fiscal year 2018 and a record 937 approvals in fiscal year 2017.

In a prepared statement, Acting FDA Commissioner Dr Ned Sharpless said: “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 US. 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.