In the 2018 fiscal year, the Food and Drug Administration set a record by approving and tentatively approvingĀ 971 generic drugs, including a record-breaking month with 110 generic drug approvals in October. This eclipses the previous record set inĀ 2017Ā 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 USĀ drug prices among theĀ highest in the world, generics provide significant financial relief forĀ millionsĀ using prescription drugs. As FDA Commissioner Scott Gottlieb recentlyĀ announced, āThrough our efforts, generic drugs entering the market from January 2017 through July 2018 saved consumers $26 billion through the lower prices they enabled.ā
Much of these record-breaking totals can be attributed to earlier policy changes. In 2012, Congress passed theĀ Food and Drug Administration Safety and Innovation Act, which allows drug companies to utilize the FDAāsĀ Accelerated Approval ProcessĀ to receive an expedited FDA review by paying aĀ fee. This process hasĀ cut nearly one year offĀ 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 aboutĀ 2,800 generic drugsĀ seeking approval. As of January 2018, the backlog was inĀ the low 100s.
Fortunately, President TrumpĀ signedĀ theĀ FDA Reauthorization Act of 2017, allowing the FDA to continue offering user fee programs for expedited approval. The reauthorization also provides an opportunity to ārevise and extend the user-fee programsā to include a variety of other applications. And more drug providers areĀ 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 onlyĀ 59 approvalsĀ in 2018 (the FDA approvedĀ 100Ā new drugs in 2017). Further, as an article from theĀ Washington ExaminerĀ notes, only 12 percent of the FDAās 2018 generic approvals were for complex drugs, which have comparatively fewerĀ generic competitorsĀ (and oftenĀ higher prices).
Perhaps most importantly, including quicker approval times for a fee only adds to an alreadyĀ extremely expensive approval process. The FDAās efforts to āderegulate by regulating,ā 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 withĀ national right-to-tryĀ regulation enacted andĀ otherĀ proposed regulatory changes gaining traction, changes to the FDAās approval processĀ could be coming.
The FDA should be praised for this accomplishment. I hope its New Yearās resolution is to break the record again in 2019.
This article appeared at FEE.org at:Ā Ā https://fee.org/articles/fda-approved-record-number-of-generic-drugs-in-2018/