FDA broke monthly generic drug approval record in July


The Food and Drug Administration approved or tentatively approved a record 126 generic drugs in July, the agency reported Thursday, an indication that Republicans are getting the faster approvals they have sought.

The agency approved 96 generic drugs and gave a tentative approval to 30 more in July, according to monthly data. Greater generic competition with pricier brand-name drugs is often thought to be a critical factor in improving drug prices.

FDA Commissioner Scott Gottlieb tweeted on Thursday that the total was the highest monthly amount ever in the history of the generic drug program.

The Trump administration and congressional Republicans often argue that greater generic competition will lower prescription drug prices.

Generic approval times have lowered in recent years in part due to the installation of a user fee program through which generic drug companies pay the FDA every time they submit a new application for approval. The FDA in turn uses that money to hire new staff and improve the drug approval process.

The FDA has a goal to review all generic drug applications within 10 months of submission to the agency. Before the first user fee program was implemented in 2012, the agency previously had a backlog of more than 10,000 applications awaiting approval.



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