Ned Sharpless, MD, the FDA's acting commissioner, said Oct.16 that the agency broke its record for most generic drug approvals this year.
The agency approved 1,171 generic drugs in the 2019 fiscal year, surpassing the previous record of 971 in 2018. It approved 125 applications for drugs that previously had no generic competition and approved an increasing number of complex generic drugs that are harder to copy and traditionally lack competition.
Dr. Sharpless said that generic drugs make up 90 percent of all prescription drug purchases in the U.S. and that generic drugs saved the healthcare system about $293 billion in 2018. He stressed that increasing generic competition can help reduce prices, improve access and benefit public health.
The agency plans to publish additional guidance and take other important policy steps in the coming months to help generic drug applicants.
Read the full statement here.