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Regulatory Focus™ > News Articles > Generic Drug Backlog at FDA: A Dive Into the Confusing Numbers

Generic Drug Backlog at FDA: A Dive Into the Confusing Numbers

Posted 01 November 2016 | By Zachary Brennan 

Generic Drug Backlog at FDA: A Dive Into the Confusing Numbers

As the debate over skyrocketing drug prices continues, at least one solution has cropped up in nearly every conversation: Reduce the generic drug backlog at the US Food and Drug Administration (FDA), create more competition and drug prices will come down.

But is the generic drug backlog, also known as the abbreviated new drug application (ANDA) backlog, that big of a problem? Or is confusion over what exactly this backlog means and how long it takes FDA to approve generic drugs creating the mirage of a problem?


First off, media outlets, from NPR to Stat, continue to say that FDA is “staring at” a backlog of more than 4,000 applications, or, in the case of NPR, that industry is “awaiting approval” of 4,036 ANDAs.

A closer look at the numbers and it’s clear neither of these statements are true. In fact, those numbers are about twice as high as the actual situation. As FDA said recently at a Generic Pharmaceutical Association meeting and as RBC Capital Markets noted in a long analysis on the backlog: There are only about 2,200 ANDAs physically with FDA.

The confusion stems from this term “pending,” which, indeed, there are more than 4,000 ANDAs “pending,” though about 1,800 of those 4,000 are awaiting a response from generic manufacturers, as they have already received Complete Response Letters (CRLs) from FDA, meaning the ANDAs are deficient and need to be resubmitted.

So, technically there are more than 4,000 applications pending, but for about half of those ANDAs, the companies aren’t awaiting approval and FDA isn’t staring at the applications because deficiencies have to be corrected. And some portion of those that have received CRLs may be withdrawn or not approved even in the next cycle.

Criticism of FDA

As RBC notes, industry has been disappointed by this high rate of CRLs (there’s been an increase of 46% between 2015 and 2016), particularly because “FDA has been criticized for returning ANDA files back to manufacturers to address issues rather than increasing the amount of communication before action dates to ensure timely approvals.”

But is that criticism warranted?

In FDA’s defense, when the Generic Drug User Fee Agreement (GDUFA) came into effect five years ago, FDA had planned for an average of 750 ANDA submissions per year, but every year other than Fiscal Year 2015 has seen more than 750 submissions.

And what’s more, the majority of ANDAs submitted in the previous two years of GDUFA are still “on the clock” and likely to meet the performance goal dates as expected.

The criticism also comes as FDA approved the highest number of ANDAs in FY 2016 ever, and as RBC says, that high approval rate is likely to “continue to accelerate going forward.”

As industry responds to the CRLs, and assuming these deficiencies are adequately addressed, RBC also points out that “the turnaround time could be less than a year and as we move forward we would expect those timelines to potentially improve.”

Furthermore, for those ANDAs submitted prior to 2014, there are fewer than 100 ANDAs that have been left untouched by FDA, with no communication to industry.

Pricing Pressure

Back to the question of lower drug prices in general, RBC data shows that the issue of a lack of generic competition isn’t so much of an issue of FDA’s speed in bringing this competition to market, but in industry submitting applications that would create this competition.

For instance, there are only 23 innovator drugs with ANDAs pending and no patent or exclusivity protection. That means there’s only 23 ANDAs awaiting approval or a CRL and nothing else stopping the generic drugmakers from bringing competition to the market except for FDA.

But there are another 125 innovator drugs with no approved generics and no ANDAs submitted.


Time to ANDA Approval

Another semi-myth worth dispelling from the NPR piece is that “the median time it takes for the FDA to approve a generic is now 47 months.”

When viewed alongside the 10-month approval time for new drugs, that 47 months seems astounding.

But as FDA’s Janet Woodcock has explained to congressmen, that 47 month figure includes ANDAs lingering since before the first year of GDUFA.

What’s more is that the median time to market has fallen considerably as GDUFA has progressed. For the fastest 5% of ANDAs approved under GDUFA, the median approval time has gone from about 24 months in FY 2013 to less than 15 months in FY 2015.

Under the next iteration of GDUFA, which will take effect in FY2018, ANDA standard review time will likely be 10 months from submission and priority review would be eight months from submission. Compare those with the 42- to 44-month average approval time prior to GDUFA and it’s easy to see why FDA can be sensitive to criticism that GDUFA is not working.

However, ANDA submissions do continue to outpace approvals and criticism of the median approval times does seem warranted when considering that it takes FDA only 10 months to review and approve much more complex new drug submissions.

As RBC notes, “We have just begun to see [ANDA] approvals begin to meaningfully ramp and as this continues we expect that annual approvals will outpace submissions which in effect will begin to reduce ‘backlog’ whether defined as ANDAs at FDA or otherwise.”


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