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FDA Chalks Up Record 1,171 Generic Drug Approvals

Analysis  |  By Steven Porter  
   October 17, 2019

The administration set a record in fiscal year 2017, beat it in fiscal year 2018, then beat it again in fiscal year 2019, with the goal of tamping down drug costs.

The Food and Drug Administration has again set a new record for generic drug approvals.

The FDA had 1,171 generic drug approvals in fiscal year 2019, including 935 full approvals and 236 tentative approvals, according to a report updated Wednesday.

That surpassed the previous record of 971 approvals in fiscal year 2018, which had surpassed the record 937 approvals in fiscal year 2017.

"Three record-setting years of generic drug approvals by the FDA are playing a major role in delivering lower prices and more access to prescription drugs, as evidenced by a historic drop in the Consumer Price Index for prescription drugs," Health and Human Services Secretary Alex Azar said in a statement.

"We congratulate the hard-working men and women of the FDA on the results of their work, which protects and improves the public health by ensuring the safety of our drug supply and boosting competition that drives prices down," Azar said.

"Lower drug prices are an important part of delivering American patients the affordability they need and, ultimately, promoting better health," Azar added. "President Trump will continue to work to put American patients first through competition, negotiation, lower list prices, and lower out-of-pocket costs."

The administration's focus on generic drugs, which account for about 90% of all prescription drug purchases in the U.S., is part of an effort to tamp down drug prices. The FDA's efforts are outlined in a Drug Competition Action Plan.

"We're encouraged to see that the pipeline of generic drug applications is strong and that there is ongoing interest in the development of generic versions of complex drugs and of other drugs with inadequate generic competition," Acting Commissioner of Food and Drugs Norman E. "Ned" Sharpless, MD, said in a statement.

"In the coming months, we plan to publish additional guidances and take other important policy steps to assist generic drug applicants, including planning additional conferences on generic drug development to further engage with stakeholders and generic drug developers," Sharpless said. "We will continue to do all that we can to facilitate a stable, competitive market to increase access to medicines."

Steven Porter is an associate content manager and Strategy editor for HealthLeaders, a Simplify Compliance brand.

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