Generic Drug Review At US FDA: Has Submission Rush Ended Or Just Paused?
Executive Summary
Excitement to get a 10-month ANDA review may have waned in January as submissions plummet, but can approvals keep up?
Sponsors' excitement to claim a potentially 10-month ANDA approval may have diminished when the clock turned to the new year.
After submitting 424 ANDAs combined in October, November and December, sponsors sent only 57 applications to the agency in January, according to data posted Feb. 7. It is a substantial drop-off that may signal the rush that characterized the start of fiscal year 2017 may have ended.
The January total is nearly 53% lower than the monthly average number of ANDAs that have been submitted, as well as the lowest monthly total since April 2016. It also is a significant drop from the 235 ANDAs that were submitted in December (see charts).
Source: FDA ANDA activity report data
When FY 2017 began, FDA's Office of Generic Drugs rolled out a 10-month review timeline for the first time, along with a lower user fee. A number of sponsors likely were holding applications to take advantage of it rather than use the 15-month pathway that was in place in FY 2016. (Also see "Another ANDA Submission Surge Begins" - Pink Sheet, 21 Nov, 2016.)
A spike eventually leads to a lull, however. In the months after the generic drug user fee program's most famous ANDA bolus in FY 2014, the agency only received eight ANDAs combined over the following two months. (Also see "ANDA Lull Begins: OGD Receives Four Applications In July" - Pink Sheet, 25 Aug, 2014.)
Robert Pollock, senior advisor and outside director to the board of Lachman Consultant Services, told the Pink Sheet that it is unclear whether this rush is over because projecting industry and FDA action is difficult. But he also said more submission spikes are expected throughout the year.
In the GDUFA era January traditionally is a slow month for submissions, in part because December tends to be busier than normal as companies meet their year-end goals by submitting applications.
The 76% difference between December and January submission totals in FY 2017 was significant – the second largest drop seen since GDUFA began in October 2012. In FY 2016, the difference was 78% (see table).
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New Year's Revelations: ANDA Submission Trends |
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|
Fiscal Year |
December |
January |
Change |
|
2013 |
163 |
58 |
-64% |
|
2014 |
225 |
85 |
-62% |
|
2015 |
43 |
27 |
-37% |
|
2016 |
180 |
40 |
-78% |
|
2017 |
235 |
57 |
-76% |
|
Source: FDA ANDA activities report data |
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The drop-off likely is good news for OGD. Even though it has maintained high approval rates for more than a year, it looked as if the agency could fall further behind with its workload if industry maintained its first quarter submission pace. January's figure lowered industry's expected FY 2017 total to 1,443. In December the expected annual total was nearly 1,700 ANDAs, which would have been a new submission record. Still, the new expected total is only 30 less than the FY 2014 record. (Also see "ANDA Stress Test: End-Of-Year Submission Bolus Pressures US FDA Review System" - Pink Sheet, 9 Jan, 2017.)
RTRs Skyrocket To More Normal Level
A potentially bad sign for some sponsors looking to take advantage of the new faster approval time: refuse-to-receive numbers jumped in December, a possible indicator that some applications in the bolus were not up to agency standards.
FDA will refuse to receive an application when its filing review determines that the ANDA is missing necessary elements. OGD reported 24 RTR actions in December, which is triple the total reported in November and the highest total since May 2016. January figures have not been posted.
As sponsors worked to finish and submit ANDAs by the end of the year, typically mistakes or omissions are made, which can lead to an RTR. It is not clear how many of the submissions sent as part of the bolus were among those refused, but it seems reasonable that some completed the filing review in December.
Refusals were down substantially compared to previous years at the start of FY 2017. The December jump now puts the total more in line with historical monthly averages. (Also see "Generic Application Quality Showing Signs Of Improvement" - Pink Sheet, 4 Jan, 2017.)
Approvals Drop For Second Straight Month
FDA's approval output also dropped somewhat for the second consecutive month, although it still remains at its elevated level seen since 2015.
OGD reported 51 approvals in January, which is five fewer than the December total. It is the lowest monthly output of FY 2017 so far, but the same as what was reported in the last two months of FY 2016.
The agency now is averaging 55 approvals per month, which still is faster than the 54 per month it averaged in FY 2016. OGD also remains on pace to break the record for number of approvals granted in a fiscal year, which it set last year. (Also see "ANDA Approvals, Complete Responses Hit Record In FY 2016" - Pink Sheet, 12 Oct, 2016.)
The trend down in approvals may be concerning to industry, but it appears that there also tends to be a drop in approvals between December and January, similar to the decrease in submissions.
In four of five fiscal years under GDUFA, OGD has approved fewer ANDAs in January than the previous December. The one exception was FY 2014, when the agency approved 34 ANDAs in January after approving 30 in December.
Approvals still will have to increase on average above their current levels if FDA is to gain a better handle on its ongoing and incoming ANDA workload. (Also see "Dark, Then Dawn: ANDA Workload Approaching Steady State After 2014 Eruption" - Pink Sheet, 28 Mar, 2016.)