FDA, Generic Manufacturers Want Faster GDUFA Approvals

June 19, 2015

Generics industry groups told FDA officials during a public meeting Monday that review times and approvals of generic drugs have slipped significantly since implementation of the Generic Drug User Fee Act, and they called for major changes when the program is reauthorized in fiscal 2018.

Median review times for generic drug applications for the current year are running at about 48 months, said David Gaugh, GPhA senior vice president for sciences and regulatory affairs. That’s up from 42 months in fiscal 2014 and 36 months in 2013, the first full year after GDUFA took effect on Oct. 1, 2012, he said.

To make matters worse, overall approval numbers have declined under GDUFA — from 619 in 2012, to 535 in fiscal 2013 and about 500 in 2014. That’s just a fraction of the 1,473 generic applications GDUFA had projected industry would submit in 2014.

Keith Flanagan, director of the FDA’s Office of Generic Drug Policy, acknowledged the agency has faced workload challenges. The agency had anticipated receiving 750 ANDAs per year, but the actual numbers were 1,025 in 2012, 968 in 2013 and the nearly 1,500 logged last year.

Two-thirds of the way through the current fiscal year, the FDA has approved just 346 generics, Gaugh said.

$227 Million in Unused Funds

The FDA and industry jointly negotiated GDUFA, with industry paying annual fees of $299 million through Sept. 30, 2017, when the current funding cycle expires. The idea is that by helping to fund the drug review process, companies will see their products approved faster.

Since GDUFA’s inception, the FDA has invested roughly $621 million into the program, including 950 new agency hires.

Gaugh said generics makers are confounded that the FDA still has $277 million in unused funds, which could be applied to site inspections or approvals to address the sluggish pace of reviews and the backlog which exceeds 4,000 applications — but has not done so.

Under GDUFA, the FDA set a goal of achieving parity of cGMP inspection frequency between foreign and domestic manufacturers of generic active pharmaceutical ingredients and finished dosage forms by 2017. Inspections were distributed fairly well in the U.S., Europe and Asia during fiscal 2013, according to a report last month by the HHS Office of Inspector General (DID, May 7).

But the increase in foreign inspections has come at the expense of domestic ones, and the slower pace of U.S. inspections could adversely affect API facilities with the best compliance histories, said Alan Nicholls, chairman of the Society of Chemical Manufacturers and Affiliates’ Bulk Pharmaceuticals Task Force. Half of U.S. manufacturers may not be inspected within a three-year cycle, causing them not to be out of compliance with a requirement of many foreign countries that finished drug products be reauthorized before they are exported from the U.S.

Moving forward, SOCMA wants the FDA to consider a fee waiver or discount for small businesses during negotiations for GDUFA II — similar to what is provided to small devicemakers under the Medical Device User Fee Act. Currently, all generics makers pay the same fees, regardless of size: $58,730 to submit an ANDA and between $247,717 and $262,717 for a facility inspection. The higher-than-expected facility fees, in particular, have proved a barrier to entry for some small businesses, Nicholls said.

SOCMA wants overall user fees under GDUFA II to be reduced to better align with the actual needs of the program. According to SOCMA, the original baseline cost estimate of $299 million was too high, based on user fee carryover of $277 million at the end of fiscal year 2014.

Comments on Docket No. FDA-2012-N-0882 are due by July 15. Negotiations on GDUFA II will start in the fall. — Jonathon Shacat