Faster FDA adds a positive spin to 2016's disappointing approval record

With 2016 confirmed as a disappointing year for the number of new drug approvals there was at least one encouraging trend to emerge from the FDA’s output: approval times got noticeably quicker versus the previous year (see analysis below).

Any assumption that this was a direct result of a lighter workload is disproved by the agency’s own statistics, so it seems that efforts over recent years to speed up the US regulatory process are having the desired effect. Industry will be keen for this record of improvement not to stall, given that potential candidates to run the FDA under the Trump presidency have called for shake-ups to the drug approval process.

The 25 novel therapeutics approved last year by the FDA’s two drug review units, CDER and CBER, amounted to a decade-long low. The agency itself put this down to a natural phasing effect, whereby five 2016 PDUFA actions were approved in 2015 and fewer action dates fell into the calendar year, as well as a noticeable uptick in the number of complete response letters issued.

CDER, the department responsible for reviewing small molecule and certain biological applications, received 36 NME applications, slightly higher than the decade average of 35, the agency has said.

So, with no evidence of a lull in regulatory activity, the improvement in drug approval times that the graph above and analysis below suggest, would appear to be real.

The improvement overall last year was driven by a considerable quickening in the pace of standard approvals. Priority reviews were pretty much bang on the 10-year average, while breakthrough therapies appear to have slowed.

However, this last category accounts for a relatively small number of applications, and it is clear that it continues to benefit from an incredibly fast review process; given that it has not been around very long it is probably too soon to draw any meaningful conclusions from the data regarding trends in timeliness.

These averages shift considerably year to year, however, so again caution should be taken when attempting to conclude anything too concrete from this analysis. For example 2015, a huge year for drug approvals, saw a substantial lengthening in approval times.

And of course there will always be outliers; it is notable that 2016 saw no applications take an inordinate time, something that helped flatter the year’s stats.

This analysis is based on EvaluatePharma data, which calculate approval time from the date of acceptance of a filing to the first approval.

The top job

Still, looking at averages over the decade, which stretches across three iterations of PDUFA legislation, makes it hard to argue against a trend towards shorter timelines, particularly for standard reviews. The picture for priority reviews has probably been complicated by the introduction of breakthrough therapy designations.

The current PDUFA legislation expires in September, and in terms of novel drug approvals the sixth version of the legislation looks likely to contain measures to increase the flexibility of the process. Proposals include an option for the FDA and sponsor to agree on a formal communication plan during the application review.

With the new FDA commissioner yet to be appointed, few will want to see major upheavals at the agency that risk the efficiency of the system. With much of the framework of PDUFA IV already agreed it seems unlikely that a new chief could make much of an impact on this legislation. And if anything the current names in the frame seem more intent on loosening regulatory frameworks.

Whoever ends up getting the top job, the pressure is on for the agency to build on these improved approval times.

 NME approval numbers and time over the past decade 
Priority review Standard Breakthrough therapy Total
Year Number Avg time (months) Number Avg time (months) Number Avg time (months) Number Avg time (months)
2016 11 9.6 8 12.9 6 6.9 25 10
2015 16 15.2 29 18 11 6.7 56 15
2014 13 8.4 23 16.2 9 4 45 11.5
2013 9 6.9 24 18 2 5.4 35 14
2012 14 6.6 28 18 1 3.5 42 14
2011 16 12.5 18 19 - - 34 16
2010 10 9.4 16 14.1 - - 26 12.3
2009 13 9.8 21 15.3 - - 34 13.2
2008 9 10.4 22 19.4 - - 31 16.8
2007 13 7.6 13 15.8 - - 26 11.7
2006 13 7.2 16 22.2 - - 29 15.2
Source: EvaluatePharma

To contact the writers of this story email Amy Brown or Edwin Elmhirst in London at or follow @ByAmyBrown or @EPVantage on Twitter

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