FDA shatters generic drug approval record

The Food and Drug Administration had another record-setting amount of generic drug approvals for federal fiscal 2018. (Pixabay)

The Food and Drug Administration has approved or tentatively approved 1,028 generic drugs since the end of July, ensuring another record federal fiscal year of approvals.

The agency’s total already surpasses the 971 approvals for the 2018 federal fiscal year, which runs from Sept. 30 to Oct. 1.

“A robust generics drug program isn’t just about how many applications we approve in a given month or year,” said FDA acting Commissioner Ned Sharpless in a tweet Friday. “We continue to efficiently and successfully work with industry to improve the quality of their applications.”


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Sharpless said the agency has focused on decreasing the number of review cycles for applications and working with companies earlier in the review process to ensure applications are prepared correctly.

RELATED: Latest generic drug deal puts hospital-owned Civica Rx ahead of schedule

The agency has increased resources for generic drug approvals since the passage of a generic drug user fee program back in 2012. The Trump administration’s drug pricing blueprint also called for more drug price approvals.

However, while generic drug approvals have increased, research shows that the highest driver of prescription drug costs is specialty drugs for chronic conditions such as cancer.

A recent drug pricing forecast from Vizient’s pharmacy program found that health systems can expect a nearly 5% hike in the cost of drug purchases next year. The report found that inflation is going to be more than 4% in the specialty drug market.

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