An FDA study determined reviewers still have a ways to go to begin acting on ANDAs within 10 months – the deadline they will be required to meet in two years under the generic user fee program.

The results of the internal review can’t be overly pleasing for sponsors; most applications still require several years to gain an approval or tentative approval.

But reviewers do appear to be issuing first actions, which include approvals as well as “complete response” letters and withdrawals, faster in FY 2014 than prior years. It is one sign that FDA is, in fact, moving its freight quicker and that new hires and other changes are helping.

Improvements will become noticeable soon, especially as new staff is trained and becomes more independent, Ted Sherwood, acting director of FDA’s Office of Generic Drugs Office of Regulatory Operations, said in an interview with “The Pink Sheet.”

“We’re not going to be able to quadruple output overnight,” Sherwood said. “But what you will see is hopefully a nice sort of increase. … Hopefully we can just build up until we get that steady state that I think everybody would like to see in the program.”

FDA already has exceeded its hiring goals to add more reviewers and other staff to handle GDUFA responsibilities. Near the end of 2014, more than 1,000 people had been added for GDUFA functions, although not all of those positions will be permanent ([A#14150120003]).

ANDA Complexity, Sponsor Experience Affect Review Times, FDA Says

Among the tenets of GDUFA was to improve ANDA review times, which had been lengthening in the years leading up to the program’s 2012 launch.

But lately, industry has raised concerns that ANDA review times have been stagnant at best since GDUFA has launched ([A#14141028005]).

And as the launch of formal discussions on the next iteration of the user fee program draws closer, industry is openly questioning whether GDUFA should be reauthorized at all ([A#00150427005]).

FDA argues that approval times are governed by a number of factors beyond its control. Culprits include incomplete or insufficient submissions, according to slides presented at a March 23 meeting between FDA and representatives of the Generic Pharmaceutical Association.

“Certainly as you get more complex products in place and certainly an increase in newer companies submitting applications, all those are sort of work that’s not necessarily reflected in the numbers in terms of submissions, but certainly are reflected in the level of work that goes on within the ANDA program,” Sherwood said.

The agency said in its fiscal year 2016 presidential budget request justification that review times were not expected to improve in FY 2015 or FY 2016. FDA conservatively estimated the median time from ANDA receipt to approval would remain at 42 months ([A#14150210002]).

FDA repeatedly has said sponsors have to improve the quality of their submissions if they want to see improvements in review speed ([A#00131104008]).

Almost No GDUFA-Era Approvals

The study of ANDA time to tentative and full approval indicated that sponsors’ worries may be justified.

Almost none of the ANDAs submitted in FY 2013 and FY 2014, the first two years of GDUFA, have received an approval or tentative approval.

It has taken FDA three to four years or more to approve or tentatively approve half of the ANDAs submitted from FY 2008 to FY 2010. And more than three years after submission, less than 25% of ANDAs submitted in FY 2012 have received a full or tentative approval, according to the slides.

Still, agency reviewers appear to have remained consistent in their annual number of approvals, despite the changes required under GDUFA and drastic expansion and realignment of staff.

More than 400 ANDAs have been approved every year from FY 2007 to FY 2014, according to the slides.

“It means we’re hanging in there with all the new stuff that’s coming through,” Sherwood said.

So far in FY 2015, approvals have been steady and remain close to the previous year’s pace as submission levels have dropped dramatically Also see "FDA Generics Office To Be Managed By Relative Unknown" - Pink Sheet, 31 March, 2015..

First Actions Improve

The agency is performing better issuing first actions, however. Among FY 2014 applications, first actions seem to be arriving quicker than previous years.

ANDA Time To First Action

The results of FDA’s study of the time to “complete response,” withdrawal, tentative approval, or approval of an ANDA.

Source: FDA presentation slides

FDA seems to have needed less time to get through more of the first quarter of the submissions than previous fiscal years (see chart).

However, in most cases since FY 2008, FDA has taken two to three years to provide a first action on half of the submissions it receives in a given fiscal year, according to the slides.

While there are a number of variables affecting FDA performance, including several it cannot control, it still appears those curves will have to bend significantly in order for FDA to meet all of its GDUFA goals.

The agency agreed to provide a first action on 60% of ANDAs received in FY 2015 within 15 months. The goal increases to acting on 90% of those received in FY 2017 within 10 months ([A#00111212020]).

Sherwood said “we’re in very good shape” as far as meeting year three performance goals.

“I think what you’ll see is things are lining up very nicely at this point,” he said.

Meeting the longer-term goals also remains in sight, Sherwood said.

Basing goals on first actions, rather than approvals and tentative approvals, makes a significant difference for FDA, but the agency still has indicated that it will focus on approvals ([A#14141212001]).

Most FY 2014 ANDAs Still Pending

During GDUFA’s first two years, FY 2013 and FY 2014, nearly 2,400 ANDAs were submitted. FDA data suggest the vast majority of the applications were still considered pending as of January, according to the slides.

A few FY 2013 ANDAs were listed as approved, and a significant number received a “complete response” letter or were withdrawn, but most were pending.

Among FY 2014 ANDAs, nearly all of the submissions were considered pending. Only a few had received CR letters or were withdrawn, according to the slides.

Those applications are not on a formal review clock, which began with applications arriving in FY 2015, although most of them should receive target action dates.

Target action dates are among the internal communications and process changes that OGD has undertaken to help sponsors gain a better idea of where their ANDAs stand in the review process, in part so they can make launch plans ([A#14141218005]).

ANDA Time To Approval, First Action Curves Need To Bend

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