In the 2018 fiscal year, the Food and Drug Administration set a record by approving and tentatively approvingย 971 generic drugs, including a record-breaking month with 110 generic drug approvals in October. This eclipses the previous record set inย 2017ย of 937 approvals.
Generic drugs play an important role in the US pharmaceutical market by providing patients with an alternative, and often much cheaper, treatment options. With USย drug prices among theย highest in the world, generics provide significant financial relief forย millionsย using prescription drugs. As FDA Commissioner Scott Gottlieb recentlyย announced, โThrough our efforts, generic drugs entering the market from January 2017 through July 2018 saved consumers $26 billion through the lower prices they enabled.โ
Much of these record-breaking totals can be attributed to earlier policy changes. In 2012, Congress passed theย Food and Drug Administration Safety and Innovation Act, which allows drug companies to utilize the FDAโsย Accelerated Approval Processย to receive an expedited FDA review by paying aย fee. This process hasย cut nearly one year offย the average time it takes for generic drug approval and has greatly expanded the generic drug market. Before the act passed in 2012, the FDA faced a backlog of aboutย 2,800 generic drugsย seeking approval. As of January 2018, the backlog was inย the low 100s.
Fortunately, President Trumpย signedย theย FDA Reauthorization Act of 2017, allowing the FDA to continue offering user fee programs for expedited approval. The reauthorization also provides an opportunity to โrevise and extend the user-fee programsโ to include a variety of other applications. And more drug providers areย utilizing the process.
But much work remains to be done. While generic drug approvals are at record-breaking highs, new drug approvals languish behind with onlyย 59 approvalsย in 2018 (the FDA approvedย 100ย new drugs in 2017). Further, as an article from theย Washington Examinerย notes, only 12 percent of the FDAโs 2018 generic approvals were for complex drugs, which have comparatively fewerย generic competitorsย (and oftenย higher prices).
Perhaps most importantly, including quicker approval times for a fee only adds to an alreadyย extremely expensive approval process. The FDAโs efforts to โderegulate by regulating,โ such as by charging more for a less burdensome approval process, are an improvement. Unfortunately, it is still a poor substitute for genuine deregulation. But withย national right-to-tryย regulation enacted andย otherย proposed regulatory changes gaining traction, changes to the FDAโs approval processย could be coming.
The FDA should be praised for this accomplishment. I hope its New Yearโs resolution is to break the record again in 2019.
This article appeared at FEE.org at:ย ย https://fee.org/articles/fda-approved-record-number-of-generic-drugs-in-2018/