In October 2018, United States Food and Drug Administration (FDA) announced that it had approved – and tentatively approved – more generic drugs in fiscal year (FY) 2018 than in any other year prior.
FY 2018 saw a total of 971 approvals, 781 final approvals and 190 tentative approvals, a number just higher than the 937 total in FY 2017.
“When I started as FDA commissioner, I made clear that one of my top priorities would be ensuring the agency does all it can to help ensure American patients have access to affordable, quality medicines that meet their needs. To accomplish this, we have taken many important actions to encourage the timely development and approval of lower-cost generic drugs and are beginning to see results,” FDA Commissioner Scott Gottlieb said in a statement.
Of the 971 approvals, roughly 12% were for complex generics – like EpiPens – while 95 first generic drugs were approved. Three new drug approvals received a Competitive Generic Therapy (CGT) designation this year, meant to expedite the development and review of generic versions of products that lack competition. The first generic to receive the designation came for several strengths of potassium chloride oral solution, which is indicated for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible.
A report by PricewaterhouseCoopers identified a surge in the number of approvals since President Donald Trump signed the 2017 Food and Drug Administration Reauthorization Act (FDARA). “For some generics, approvals are coming in as few as eight months instead of the previous standard of 15 months in Fiscal Year 2016,” the study reports. In 2017, FDA fully approved 86.5 percent more generic drugs than in 2014. The pace of approvals increased further in 2018, as Gottlieb announced.
In FY 2018, FDA also set a record for most complete responses in one year. However, the gap between this year and years prior – 2,548 complete responses have been issued in 2018 vs. 1,603 in FY 2017 and 1,725 in FY 2016 – may be attributed to either a spike in applications or because as part of the migration to GDUFA II, there was a bridging process that established a goal date of July 31st for 800 applications that did not have an official goal date in GDUFA I.
Gottlieb also acknowledged, “Our work is not done. We’ll continue taking additional steps to help ensure patients have access to the drugs they need by making generic drug approval more efficient and predictable. We are doing this by continuing to streamline the generic drug review process to get more competitors on the market. We have found that having three or more generic competitors brings prices down more sharply than with only one or two generic competitors.”