FDA speeds ahead with new generic approvals in 2015: Report

Kathleen Uhl

The FDA is finally seeing the fruits of its labor under a program meant to speed up approvals for generic drugs. The agency approved more generics in 2015 than any year prior and made strides toward accomplishing its approval goals by 2017.

Regulators signed off on more than 700 generic drugs last year--the highest figure to date, according to the FDA’s first generics annual report, which the agency’s Office of Generic Drugs (OGD) released this week. In December, the FDA handed out 99 approvals, the highest monthly number of approvals and tentative approvals since the generic drugs user-fee program started a few years ago.

The FDA’s report comes at a critical moment. Generic drugs comprise 88% of prescriptions dispensed in the U.S., the agency said. And generics saved the U.S. health system $1.68 trillion from 2005 to 2014, it added, a number that payers and others concerned with rising drug costs are quick to crow about.

Back in 2012, Congress passed a law, the Generic Drug User Fee Act (GDUFA), which gave the FDA additional funds to facilitate generic drug approvals. The industry said it would do its part to help, too, pledging $300 million in fees each year as part of the 5-year program.

At the time the law was enacted, the FDA’s generic approval backlog included 3,866 abbreviated new drug applications (ANDAs) and 1,873 prior approval supplements (PASs). Needless to say, the agency was having trouble keeping up the pace.

But the agency has made headway after a few years of work, it said in its report. As of Dec. 31, the FDA has handled 84% of those ANDAs and 88% of PASs. The filing backlog for ANDAs is almost eliminated. For reference’s sake, in August 2014 there were more than 1,100 applications that had not been addressed by the agency.

An improved ANDA review system is partly to thank for the progress. Filing is now performed in real-time, the FDA said in its report, which helps usher through applications. And each application gets a regulatory project manager (RPM), a point of contact for companies filing for approval.

The agency isn’t finished just yet, though. The FDA wants to eliminate 90% of the backlog for ANDAs by 2017 and reduce processing times for applications. At least so far, it’s “on track for meeting all those goals,” OGD Director Kathleen Uhl said in a recent blog post.

But “(d)espite our progress, we have a lot more work to do,” Uhl said. The OGD will hold a public meeting on May 20 to get “valuable feedback” on its generic drug approval efforts and to “help us chart directions forward,” Uhl said.

- read the report (PDF)
- here’s the blog post