FDA

Spurred by Gottlieb, FDA on track to the most generic drug OKs ever in 1 year

A little more than eight months into 2017 and the FDA is on pace to break its record for abbreviated new drug application — or ANDA — approvals from last year.

According to the latest version of the activities report of the generic drug program, FDA has approved 633 generic drugs in FY 2017, which compares with a total of 651 approvals in FY 2016.

Also a positive: complete responses for generic drugs are down significantly from last year, with 1,292 sent so far in FY 2017, which compares with 1,725 complete responses sent in FY 2016.

The steady rise in approvals follows a push from FDA commissioner Scott Gottlieb to approve more generic drugs to bring down costs and highlight situations where generic drugs are lacking, as well as a steady increase in staff at the Office of Generic Drugs (OGD) and faster review timelines thanks to the Generic Drug User Fee Amendments (GDUFA).

OGD is also working to identify new approaches to use Hatch-Waxman authorities to maximize competition. As part of such efforts, an FDA team will form a new workgroup to evaluate policies and possible new legislative ideas to ensure a better balance between innovation and access.

The second iteration of GDUFA, which will take effect in October, will further speed ANDA approvals for some applications where the brand version lacks competition.

However, reducing the number of review cycles and speeding approvals of more complex generics are two outstanding issues that industry and the agency have said need to be addressed.


First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.


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