FDA Speeding Generic Drug Approvals: Not Just Lip Service

Regulatory NewsRegulatory News | 10 July 2017 |  By 

May and June 2017 have seen the most generic drug approvals since the US Food and Drug Administration (FDA) began tallying its monthly approvals, lending credence to FDA Commissioner Scott Gottlieb's pledge to speed approvals and lower drug costs.

According to the activities report of the generic drug program, FDA approved and tentatively approved 96 generic drugs in May and 100 in June (a level FDA has not seen since December 2015 when 99 generics were approved and tentatively approved). May and June's numbers also compare to about 70 full and tentative approvals for the agency in the other months of 2017.

In addition, the number of complete response letters issued to the generic drug industry has been declining in 2017, from a high of 190 complete responses issued in March, to a low of 87 issued in June.

2017 has also seen a rising number of first generic approvals, which usually begin to help lower the cost of their brand name reference products. So far, 38 first generic drugs have been approved in 2017 (73 first-time generics were approved in 2016), including 16 in May and June (an featuring a generic version of Gilead's HIV drug Truvada).

And this is just the beginning of what FDA Commissioner Scott Gottlieb has singled out as a priority for the agency.

FDA recently announced it will expedite the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug, and the agency has published a list of all off-patent pharmaceuticals with limited or no competition.

The next iteration of the Generic Drug User Fee Amendments (GDUFA) also will make the agency more consistent in its faster generic approvals.

Outstanding Issues

But reducing the number of review cycles for the generic drug industry and speeding the approvals of more complex generics are two outstanding issues that industry and the agency have made clear need to be addressed in the future.

Last April, Kathleen Uhl, director of the US Food and Drug Administration's (FDA) Office of Generic Drugs, said that only 9% of ANDAs won approval in the first review cycle, which is significantly lower than the more than 90% of new drug applications that win approval in the first review cycle.

And though the 9% shows significant progress on the approximately 1% of ANDAs that won approval in the first review cycle before the first Generic Drug User Fee Amendments (GDUFA) of 2012, each time FDA has to complete another review cycle means more time before the generic can win approval.

More post-market evaluation of generics and supporting the review of complex generics were also targeted as GDUFA priorities for 2017.

Bernstein biotech analyst Ronny Gal also said in a note to investors on Monday that FDA's generic drug approvals "are finally accelerating," though "the larger value would come from FDA approvals of the more complex generics and we are yet to see those."


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