FDA approving generic drugs at record pace, report finds

The FDA is continuing to set records for the number and speed of its generic drug approvals. In fiscal year 2018, the agency approved 781 generics, up 90 percent from 2014, the first year the Generic Drug User Fee Act was in full effect, according to a new report from multinational professional services firm PwC.

Here are five things to know:

1. Since the implementation of the Generic Drug User Fee Act — which was designed to speed up the approval process — the FDA has continuously set generic drug approval records. For example, 409 generics were approved in 2014, followed by 492 approvals in 2015, compared with 651 in 2016 and 763 in 2017.

2. Bringing generic medications to market, to introduce competition, has been one of the Trump administration's most concrete efforts to lower drug prices.

3. The surge in generic drug approvals is also attributed to substantial changes to generic drug regulation under the FDA Reauthorization Act of 2017, which increased FDA funding and featured regulatory incentives to shorten the time it takes a drug to reach the market.

4. The FDA Reauthorization act gives priority review to generic drugs, permits sponsors of generic drugs to receive six months of market exclusivity and expedites the preapproval inspection process.

5. While the new regulations result in faster approvals, about 80 percent of generic drugmakers failed to obtain approval on the first review, indicating there is still room to improve the process.  

Read the full PwC report here.

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