With OGD Teetering on the Precipice of Success – GDUFA II Negotiations Underway


The Office of Generic Drugs (OGD) would like the generic industry to know that it is poised to bring home the bacon on approvals.  The industry has the table set, but, according to some, the meal has yet to be served.  This “trust, but verify” position comes at a time when the GDUFA II negotiations are just underway.

OGD has begun to deliver on approvals, although the last few months have shown marked improvement, but not yet at a pace at which the generic industry is entirely pleased.   OGD has, however, shown the ANDA sponsors they are very good at issuing Information Requests (IRs) and Easily Correctible Deficiencies (ECDs) and has, in some instances, buried sponsors with such correspondence, most of which have a 30-day turnaround time for the industry response.  All well and good, but, just like OGD has had to deal with the backlog of ANDAs, industry must now learn to deal with the backlog of IRs and ECDs piling up at their doors.  The new generic drug review paradigm must now be adequately managed at the sponsors.

This just goes to show you what the law of unintended consequences assures – you just never know if one’s success becomes another’s failure or if it will be your problem!  Hopefully, over time, there will be a balancing out of this yin and yang between OGD and industry, and a rhythm will develop that will permit both sides to get the job done without overwhelming the other.

So how do you determine what you do for GDUFA II without having a full picture of where GDUFA I has taken you?  It will be interesting to see the results of the negotiations, where industry and FDA land on new asks or revised goals for the second 5-year reauthorization of this important legislation.

With Congress placing pressure on both the industry and the Agency to address pricing concerns, it takes me back to 1984, when Hatch-Waxman Act (Waxman-Hatch Act at the time) was first passed.  Isn’t it an interesting road we have all traveled since then?  The most interesting is that the same mantra is being heard – we need to lower prescription drug costs.  Over the years, we have seen generic bashing, pay-for-delay, patent suits, petitions delaying generic entry, the FTC getting involved, legislation enacted to prevent exclusivity parking, legislation passed to permit forfeiture of 180-day exclusivity, REMS and restrictive distribution systems impacting generic approvals, and a number of other strategies advanced that may be a contributor to attempts to upset the delicate balance that was established between the brand and generic industry.  Lest we forget the Hatch-Waxman Act’s full title – the Drug Price Competition and Patent Term Restoration Act, designed to provide a give-and-take, and speeding up the ability to approve generic drugs.  Both sides gave up something and both sides gained something.  Generics got the right to rely on previous Agency findings of safety and efficacy without having to repeat costly and unnecessary duplicative clinical testing, and, in return, brand name companies were rewarded with patent extensions and periods of market exclusivity.

Now that GDUFA is up for renegotiation, the focus is still on improving the speed at which the Agency can review and approve generic drugs and the transparency in that process.  In 1984, we were hearing the same message.  What does this show us? Without closely monitoring the present, we are doomed to repeat the past!