FDA generics approvals up 90% compared to 2014

pharmafile | October 25, 2018 | News story | Sales and Marketing FDA, Trump, generics, pharma 

Continuing to build on its successes in toppling previous benchmarks, it has emerged that the FDA’s total number of generic drug approvals this year is 90% higher compared to the fiscal year of 2014.

Throughout the fiscal year of 2018, the US regulator approved 781 generic drugs, topping the previous year’s total of 763, according to PwC’s Health Research Institute. Three years earlier in 2014, the agency approved 409 generic treatments, and 651 in 2016, showing a marked improvement year on year.

The improvement can be at least in part attributed to the Trump administration’s drive to accelerate drug approval times through the cutting of regulatory red tape – specifically generic therapies, in the interests of creating competition to drive down rampant drug prices. The push is part of efforts to make good on the President’s repeated promises to rein in the inflated prices pressed upon US consumers, amidst his infamous claims the industry is “getting away with murder”.

Some of these efforts include designations awarding generic drugs market exclusivity for six months, and a goal of reviewing those generics entered into the priority pathway in eight months instead of ten.

The news builds on celebrations of the agency’s successes earlier this year, when it became apparent that it had approved more generic drugs in July than any previous month of 2018.

Matt Fellows

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