GDUFA Policy Hearing – Where is the Silver in this Lining?

On September 17, 2014, FDA hosted the GDUFA Public Hearing on Policy Development.  With quite a few generic firms of all sizes represented at the hearing, a series of recurring themes appeared to resound.  Lack of communication and transparency from FDA and ever growing facility fees that stifle entry of small new players were the loudest complaints from the audience.

GPhA’s presentation (delivered by David Gaugh, R.Ph., Senior Vice President for Science and Regulatory Affairs) certainly echoed the communication and transparency issues expressed by the industry representatives in attendance.  But most surprisingly, GPhA noted that the median approval time for 2013 was 36 months, and, based on some back-of-the-envelope calculations, estimates that that median approval time will rise to 43 months for 2014 (based on an estimate derived from 89 applications for which data was available), also noting that the median approval time in 2003 was 16 months.  GPhA also noted that they have not seen an official figure on median approval times (which used to be one of the benchmarks for OGD performance) issued by OGD in a few years.  A footnote in their presentation cited to the fact that 19 ANDAs had forfeited 180-day exclusivity for failure to obtain approval or tentative approval within the statutory mandated review time.  They also reported that the median approval time for 10 first generic approvals was 55 months.

From what I heard about the hearing, smaller firms complained about the lack of fee waivers and the way that the facility fees are assessed annually while the ANDA is pending, instead of only being charged the annual fee after ANDA approval, as is done with the establishment fee for new drug approvals under PDUFA.

It was not a complete OGD “slam fest” as GPhA did give kudos for the Office of Generic Drugs’ (OGD) plan to issue target action dates for priority ANDAs from cohort years 1 and 2, but at the same time indicated that their members really need more information regarding the status of pending applications so they can make reasonable business decisions.  The trade association also asked OGD to clarify what Quality by Design/Quality Overall Summary (QbD/QOS) requirements and expectations are, and also to define clearly “what quality is”, relative to OGD expectations for ANDAs.

So far, it has been rough sledding for OGD during GDUFA, with most of the course being uphill and with little or no snow.  I believe that OGD is looking for some downhill racing, but is having a difficult time finding that double black diamond.  I think perhaps at this point in time they wouldn’t even mind the down slope of the bunny hill just to get some additional momentum going.  While I could not attend the hearing (I was on a plane), I could hear the shouts of the generic industry as I flew over Silver Spring.  Hopefully, things will turn around soon, as through June 15, 2014 there have been 652 GDUFA hires representing 90% of the hiring goal through FY 2014.  When this staff gets fully trained and up and running, maybe we will see reviews flying off the OGD fax machines.



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