FDA expectations for the next fiscal year of ANDA approvals and submissions appear to be underestimated.

At the same time, the Office of Generic Drugs is expecting median approval times to drop by several months, indicating a belief that the agency will make significant strides in moving pending applications through the review system.

FDA's fiscal year 2017 budget request projects the median ANDA time from receipt to approval will be 36 months in FY 2016 and FY 2017, a half-year improvement from the actual FY 2015 median time of 42 months.

FDA told "The Pink Sheet" that predicting median approval times is challenging, but said the figure was derived assuming that a mixture of approvals of ANDAs with and without review goals would be approved. Approval times are expected to decrease "due to the addition of the GDUFA resources and the GDUFA goal years ANDAs starting to be approved," the agency said.

Improvements to its internal processes are expected to "make a big difference in approval times for FY 2015, FY 2016 and FY 2017 submissions," the agency said.

The generic drug user fee program states that the majority of ANDAs submitted as of Oct. 1, 2014, must receive an action within at least 15 months and most of those submitted as of Oct. 1, 2016, must be acted upon within 10 months ([A#00111212020]).

The agency raised eyebrows when in its FY 2016 budget request the agency estimated that the median ANDA review time would be 42 months in FY 2015 and FY 2016, unchanged from the previous fiscal year.

At that time, FDA said the estimates were conservative ([A#14150210002]).

Instead, they turned out to be accurate, and industry will welcome the improved review times if the FY 2017 estimates turn out to be correct as well. But requiring three years for an ANDA review likely will continue to spur questions about the progress FDA is making in implementing the generic drug user fee program, even if the agency is hitting all the program metrics.

FDA officials already have been forced to answer questions about the pace of generic approvals in the wake of widespread anger over drug price increases ([A#14160128001]).

GDUFA reauthorization negotiations also have included discussions of ideas to improve review times (see sidebar).

[Sidebar#00160222003]

Still, the median approval time does not reflect a true reading on the state of ANDA reviews. A number of applications that were submitted before statutory review goals were implemented or were part of the official backlog have forced the median time up.

FDA said that as OGD continues to move ANDAs without formal review goals through the system, "their approval median time will suppress the median approval times" for FY 2015 through FY 2017 submissions.

FDA has said that it is making progress with the pending ANDAs without formal review goals. In many cases, applications are awaiting a response from industry, which extends the review time ([A#14151016006]).

Industry has argued that FDA should make sure it can move all the ANDAs now pending through its approval system by the end of GDUFA I in October 2017, although FDA has indicated there likely are not that many applications available for approval each month to meet that goal ([A#00151012013]).

Industry opinion of FDA performance is especially important this year because of the upcoming renewal of the user fee program and the expectation that any agency funding increases will likely come from user fees ([A#00160215006]).

Source: FDA Office of Generic Drugs activities report

Approvals, Submissions Already Exceeding Expectations

FDA is expecting ANDA approval actions to increase to 650 in FY 2016 and FY 2017, which would be an increase over the 612 approval actions in FY 2015, according to the budget request.

The estimate includes tentative as well as full approvals.

But it appears the agency already is on pace to easily exceed that figure in FY 2016.

FDA could issue nearly 700 full approvals alone in FY 2016, based on data already released (see graphic).

OGD has issued 233 full approvals through the first third of the fiscal year, which is more than 58 per month. If the agency maintains that pace through the remaining eight months, it would be expected to approve another 466 ANDAs for an annual total of 699.

The full approval monthly average dipped after a January figure that was lower than previous months, but the agency has drastically improved its approval rate since April 2015, suggesting that it can retain its current level for the rest of the fiscal year ([A#14150915002]).

ANDA tentative approvals also are on the rise. FDA has issued more than 16 per month so far in FY 2016, which would suggest a total of 195 for the year. That is much higher than the 120 tentative approvals issued in FY 2015, as well as the 91 issued in FY 2014 and 95 in FY 2013.

In all, FDA is on pace to issue a combined 894 full and tentative approvals in FY 2016, 37.5% more than it estimated in the budget document.

Submission volume also is not going according to FDA's plan.

The agency estimated 750 ANDAs would be received in FY 2016 and FY 2017 after only 539 were received in FY 2015, according to the budget document.

But the actual data indicate FDA could receive about 900.

FDA received 297 ANDAs in FY 2016 through January, according to the OGD activity report, which equates to more than 74 per month. If that rate holds through the entire fiscal year, 891 ANDAs would reach the agency, a nearly 19% increase over the estimate in the budget document.

The agency told "The Pink Sheet" that FY 2015 receipts were low "due to the stability guidance effect of FY 2014" and that receipts would increase over that figure during the next two fiscal years.

FDA received a record number of ANDAs in June 2014 as sponsors submitted applications before new enhanced stability requirements went into effect ([A#00140630007]).

Will Estimates Affect GDUFA II?

Estimates of ANDA receipts and actions have been off significantly the past few years. FDA expected to receive 1,000 ANDAs in FY 2015, which was much higher than the actual figure (see table below).

However, the estimates could create problems for GDUFA moving forward.

FDA struggled to implement the program after it launched in October 2012 in part because the estimated number of submissions were much lower than the actual number received. It resulted in FDA hiring far fewer employees than were needed ([A#00140303008]).

FDA ended up adding more than 1,000 new employees for GDUFA-related responsibilities, which was more than its goal. Not all those employees are expected to remain, however ([A#14150120003]).

FDA and industry now are considering several changes for GDUFA II, including a priority review pathway ([A#14151106001]).

Both sides will have to make assumptions about the number of ANDAs that would require the heightened speed each year.

Congress, as part of its drug-pricing solution, also could force more speedy ANDA priority reviews than estimated, which could throw off any necessary hiring and other productivity needs.

FDA already has problems hiring the personnel that it needs Also see "FDA Talent Hunt: Is Recruiting From Academia Better Than Industry?" - Pink Sheet, 30 November, 2015..

Workload estimates also could affect fee structure changes under consideration. Fees are determined based in part on the annual number of applications and manufacturers for the US generic market.

GDUFA II discussions also have included the possibility of creating a small business fee waiver, which would increase fees for those manufacturers and sponsors that do not qualify ([A#14160125001]).

Generic Drug Review Workload and Output
Program	FY 2014 Actual	FY 2015 Estimate	FY 2015 Actual	FY 2016 Estimate	FY 2017 Estimate
ANDA Receipts	1,545	1,000	539	750	750
ANDA Actions	1,521	1,550	1,958	2,200	2,200
ANDA Tentative and Full Approvals	480	550	612	650	650
Labeling and Manufacturing Supplement Actions	7,630	7,500	7,246	6,600	6,600
Source: FDA budget request congressional justifications

FDA's Generic Drug Workload, Productivity Beating Budget Estimates

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