FDA is trying to take back the issue of the generic drug application backlog, attempting to reset a bloated definition that has painted the agency's review performance in a negative light.

“There’s a big gap between our formal GDUFA commitment on the backlog and what stakeholders expect on the other,” Keith Flanagan, director of the Office of Generic Drugs’ Office of Generic Drug Policy, said Oct. 16 during a briefing on the subject.

“We think we’re exceeding expectations,” Flanagan said.

But the fact that the agency called a press conference to talk about its review performance indicates just how difficult external expectations have been for FDA.

For the purposes of the generic drug user fee program, the backlog refers to the 2,866 ANDAs that were pending with the agency on Oct. 1, 2012, the day the generic drug user fee program launched.

FDA has to act on 90% of those applications – meaning it refuses to receive or provides a “complete response” letter, tentative approval or approval – by the end of fiscal year 2017 ([A#00111212020]).

Somewhere along the way, though, the word “backlog” has grown to include other generic drug applications pending with the agency, essentially those that came in after the user fee program began but before applications started getting formal review goals.

Industry may expect the agency to approve those additional applications much faster than its current pace, but they are not part of the official backlog and are not counted as part of the commitment FDA made.

The agency has informally committed to reviewing those applications by the end of FY 2017 as well, but how to handle them could be among the new goals established for the next round of the generic user fee program.

GDUFA renewal negotiations started Oct. 7. The first monthly private stakeholder meeting to gain perspective on the issues discussed is scheduled for Oct. 19.

Four industry groups are negotiating with FDA on GDUFA II Also see "GDUFA II Negotiations: Contract Manufacturers Gain Seat At Table" - Pink Sheet, 6 July, 2015..

Going into the talks, industry has made the point on a number of occasions that the agency has been slow to approve ANDAs.

A common complaint is that the median approval time for ANDA approval remains higher than before GDUFA was implemented, despite the fees that have been paid by industry and OGD growth ([A#14150210002]).

The grievances are likely an attempt to strengthen industry’s bargaining position as it looks to make changes for GDUFA II.

But FDA argues that doing what industry wants – approving ANDAs that have languished at the agency – is going to actually make the review statistics seem worse.

Flanagan said any approval from the official backlog is going to lengthen median approval times because those applications were filed several years ago.

“From our perspective, it’s just a sign that we’re doing a good job of clearing out the very old legacy submissions,” he said.

Unknown How Long Backlog Will Exist

OGD cannot predict how long it will take to move the official backlog off its books.

FDA has acted on more than 80% of the official backlog, leaving less than 575 applications pending.

Ted Sherwood, acting director of the OGD Office of Regulatory Operations, said during the briefing that the agency is not trying to hold applications from approval.

“We get painted as being the bad guy for the time it takes, the difference is we can’t afford to blink,” Sherwood said. “We will not sacrifice the public health. ... If we’re not 110% confident, we have to hold the line.”

OGD has decided to focus on approvals, rather than actions as required in the commitment letter, in order to reduce its workload ([A#14141212001]).

Industry said recently that there are so many ANDAs pending in the official backlog that FDA would have to approve 150 applications a month through the end of FY 2017 to clear it.

That figure likely is unrealistic, given that OGD is averaging about 39 approvals per month in FY 2015. But FDA also has said it would welcome the ability to find 150 approvable applications each month ([A#00151012013]).

And of course FDA only has to issue an action letter, not grant approval, to achieve the backlog review metric.

Many Applications Awaiting Industry Response

FDA also argues that it is performing well in trying to move its entire cohort of applications without official review goals: the backlog, as well as ANDAs submitted in GDUFA years one and two.

As of Sept. 21, OGD said it had 3,810 applications pending without a formal review goal.

There were 2,662 applications pending with FDA, meaning they were awaiting a move by FDA in the review process. Another 1,148 were pending with industry, meaning the sponsor had yet to respond to an information request or another issue.

Sherwood said that the ratio of applications pending with FDA as opposed to those pending with industry is the tightest it has been under GDUFA.

FDA has reminded industry on a number of occasions that the quality of its applications, as well as the timeliness of its responses to questions, will affect approval speed.

The agency wants to limit the number of review cycles required to approve an ANDA. Today, most applications require two to five cycles ([A#00150727013]).

Generic User Fees: FDA Goes On Backlog Offensive

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