FDA’s vacation from an elevated level of new ANDA submissions continued through the start of 2015, but so far it has not translated into a dramatic increase in approvals.

Generic sponsors still may be recovering from their massive push to get submissions to the agency last summer ahead of increased requirements for stability testing, as well as adapting to new regulations as the submission lull continues.

FDA appears to have maintained its approval pace from the previous fiscal year as it begins reviewing ANDAs with formal review goals, but industry may be hoping an increase is coming.

FDA reported in its monthly generic drug program activity report, updated Feb. 26, that it received 27 ANDAs in January. It was tied for the fewest received in FY 2015 as well as a 37% decrease from the total received in December.

There have been 146 ANDAs submitted through the first four months of the fiscal year, which is far fewer from the totals during the same period in FY 2013 and FY 2014. In FY 2013 the agency had received 352 ANDAs and in FY 2014 received 409 during the October through January period (see chart).

ANDA Submissions by Month

FDA continues to see lower monthly ANDA submission totals than previous years.

Source: FDA generic drug program activities report.

The lull in submission volume now has lasted seven months. From July 2014 through January, sponsors submitted 179 ANDAs, or less than 26 per month. The agency also has not received more than 49 ANDAs in a single month during that period.

Robert Pollock, senior advisor and outside director to the board at Lachman Consultant Services, said in a Feb. 27 email that he suspected the agency’s new stability testing requirements may have played a role in the slow-down.

FDA’s final guidance requests ANDA sponsors submit more accelerated and long-term stability data in an application ([A#00130909012]).

Last year, sponsors submitted hundreds of ANDAs before the new requirements went into effect. In June 2014, the agency received an unheard-of total of 635 ANDAs ([A#00140630007]).

Pollock said that the generic pipeline may be strained after the rush and just now may be beginning to recover.

Sponsors also may not be able to obtain enough active pharmaceutical ingredient supplies, container closures or schedule the manufacturing of the necessary exhibit batches, Pollock said.

The decrease in ANDAs in FY 2015 also is dramatic considering that the majority of them must be reviewed within 15 months.

This fiscal year was the beginning of formal review goals for ANDAs under the generic drug user fee program. FDA must provide a first action (such as an approval, tentative approval, refuse-to-receive or “complete response” letter) on 60% of ANDAs submitted within 15 months ([A#00111212020]).

Approvals Remain Steady, But When Will They Increase?

Approvals also remained steady in January, apparently not taking full advantage of the lull.

FDA reported 25 approvals in January, which was four less than reported in December and three less than November. All three figures pale compared to the October 2014 total of 45.

The FY 2015 approvals total remains ahead of the total seen at the same time in FY 2014, but is 10 less than the total during the first four months of FY 2013.

It remains a promising start to the fiscal year, especially with formal review goals and other GDUFA-related policies being implemented ([A#00150105008]).

But industry may be hoping for a larger boost in approvals as the fiscal year continues.

Industry remains concerned about the lack of progress with review times, which was one of the reasons it agreed to begin paying user fees ([A#14141028005]).

FDA conservatively estimated in FY 2016 budget documents that the median ANDA review time would remain at 42 months through FY 2016, although agency officials promised improvements ([A#14150210002]).

The agency intends to focus on approvals rather than actions in order to move applications through the process faster ([A#14141212001]).

Easily Correctable Deficiencies Process Is Bright Spot

Sponsors also seemed to be embracing the easily correctable deficiency concept.

The Office of Generic Drugs now notes the number of easily correctable deficiencies (ECD) and “information request” application amendments that were submitted each month.

ECDs are problems reviewers believe can be fixed quickly. If the agency receives the correction quickly, the review will continue as planned ([A#00140721006]).

After receiving no original ECD or information request amendments for FY 2015 submissions in October, the agency reported receiving seven in November, four in December, and then 43 in January.

The ECD system is intended to help FDA complete application reviews faster and eliminate multiple review cycles.

Most ANDAs in recent years have required two to five review cycles to gain approval ([A#14141205003]).

ANDA Submission Lull Is Now A Trend, As Are Sluggish Approval Numbers

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