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Pharmaceuticals / Regulatory Affairs

Office of Generic Drugs to Focus on Approvals in Addressing ANDA Backlog

Dec. 29, 2014

The Office of Generic Drugs is pledging to catch up on a backlog of thousands of ANDAs by October 2017.

OGD head Kathleen Uhl outlined this goal in a memo to staff recently that stresses the office’s role is to approve as many applications as possible, and not simply clear the backlog by issuing complete response letters. Uhl promised further details in the coming weeks.

Attorneys who work with the FDA on ANDA submissions welcomed Uhl’s announcement, especially her emphasis on approvals.

Generics makers have worried that the FDA sees its GDUFA commitments only as issuing complete response letters to satisfy performance goals under the law, said Kurt Karst, an attorney with Hyman Phelps & McNamara.

The FDA understands the industry’s concerns, said Bob Pollock, a senior adviser at Lachman Consultants and former acting deputy director at OGD. The question is not whether the FDA knows what it needs to do but whether it has the resources to address the backlog, Pollock said.

At its peak, nearly 3,000 ANDAs sat on that backlog, which consists of ANDAs filed before GDUFA established performance goals that went into effect Oct. 1, 2014. These goals eventually require the FDA to take action on 90 percent of ANDAs within 10 months.

The FDA has said it has already made progress on addressing the backlog, assigning most applications target action dates. However, the agency still has a long way to go, as average ANDA response times now stretch past 40 months, Brian Malkin, an attorney with McGuireWoods, said.

In addition to the backlog, Uhl’s memo noted that she has named long-time OGD official Ted Sherwood to serve as acting director of OGD’s Office of Regulatory Operations, a move Pollock called a positive development because Sherwood has a track record of moving applications through the bureaucracy.

Read the memo here: www.fdanews.com/12-15-2014-OGD-Memo.pdf. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.