Posted 10 February 2016
By Zachary Brennan
As Congress continues to push for the US Food and Drug Administration (FDA) to speed the approval of new generic drugs, which could be key for keeping pharmaceutical prices in check, FDA for the first time is offering an in-depth look at where it stands with industry’s abbreviated new drug applications (ANDAs).
What’s clear from the new data on 2015 is that FDA continues to seek more information or require companies to correct what’s known as an “easily correctible deficiency” for the vast majority of ANDAs. And in case the ANDA approval process seems to be nothing more than a formality, the statistics show that FDA is actually rejecting far more ANDAs than it’s approving. In fact, for one-third of 2015, or four months, FDA rejected more than twice as many ANDAs as it approved.
FDA prioritizes the review of ANDAs for “first generics,” which offer the first round of market competition for brand name drugs as patent and exclusivity barriers to approval have been lifted or will be lifted soon. FDA also prioritizes ANDAs for which the product is in shortage, is subject to special review programs like the President’s Emergency Plan for AIDS Relief (PEPFAR), is related to public health emergencies and certain government purchasing programs, or is subject to statutory or other legal requirements.
Some in Congress are now pushing for FDA to also prioritize ANDAs for products seeing steep price increases, though that could be difficult for the agency, as it currently does not track drug prices.
As far as where FDA stands with its backlog of ANDA applications, 2,962 ANDAs are currently with FDA (as of January 2016), though 2,170 have received at least one communication from the agency staff and only 211 are pending review.
On industry’s end, 1,143 have been sent back to generic drug companies and are either pending a response from industry or have received tentative approval. FDA ended last year at a new monthly high of 99 approvals and tentative approvals in December.
The dashboard was released little more than a week after Janet Woodcock, director of the Center for Drug Evaluation and Research, told senators that the agency expects to be fully caught up with the backlog before the re-authorization of the next Generic Drug User Fee Act (GDUFA) in 2017.
Woodcock made clear that the long median times for ANDA approvals, cited often by senators, actually include ANDAs that have technically been backlogged since GDUFA began.
This year, it will take FDA about 15 months to respond to a generic firm on their ANDA, and in October 2016, companies can expect to get a response within 10 months, Woodcock said.
FDA and industry discussions on GDUFA II, which began in October, have recently focused on the ANDA review timeframe and review goal metrics, particularly around transparency, pre-ANDA processes, controlled correspondence, first generics and regulatory science.
FDA and industry also have discussed the current FDA facility evaluation model and drug master file scientific review and completeness assessments. Both sides have agreed that they are generally aligned on major principles for GDUFA II, according to minutes from a meeting in January.
Generic Drug Review Dashboard