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The Food and Drug Administration granted full approval to nearly 800 generic drugs in fiscal year 2018, a 90 percent increase over the same time period four years ago, according to a recent analysis by PricewaterhouseCoopers LLP.
Pricewaterhouse’s Health Research Institute reported there were 781 full FDA approvals in FY 2018, compared to 409 full approvals granted in FY 2014, the first year that the Generic Drug User Fee Act went into effect.
In addition, there were 190 tentative FDA approvals of generic drugs in FY 2018, compared to 91 four years earlier, the institute reported. These drugs can quickly be in the hands of consumers once patents for proprietary drugs lapse, the institute reported.
The increase in the number of generic drug approvals may help to cut costs for some drugs by making the generic drug market more competitive, according to Pricewaterhouse.
The analysis credits 2017 changes to federal rules governing generic drugs for increasing FDA funding in the approval process and creating more incentives to shorten the period needed to get pharmaceuticals to market.
The FDA also collected nearly $500 million in generic drug user fees in FY 2018, compared to $299 million in FY 2013. Those funds allow the FDA to hire more staff and improve data systems to make the approval process more efficient, according to Pricewaterhouse.
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Year-over-Year Increases in FDA Generic Drug Approvals
| Fiscal Year | # of Full Approvals | # of Tentative Approvals | # of First Generic Approvals |
| 2018 | 781 | 190 | 82 |
| 2017 | 763 | 174 | 60 |
| 2016 | 651 | 184 | 75 |
| 2015 | 492 | 120 | 73 |
| 2014 | 409 | 91 | 111 |
