OGD Finished 2010 on a High Note – Really High!

By Kurt R. Karst –     

The ANDA backlog in FDA’s Office of Generic Drugs (“OGD”) continued to grow unabated in 2010.  OGD started out the year with a backlog of 1963 original applications and ended the year up almost 400 applications, for a grand total of 2361 pending original ANDAs.  The backlog has, not surprisingly, affected median ANDA approval times.  As we previously reported, in Fiscal Year 2009, OGD’s median ANDA approval time was 26.70 months.  That was up about 5 months compared to Fiscal Year 2008 when the median was 21.65 months.  At the end of calendar year 2010, we understand that the median ANDA approval time (which includes tentative approval actions) was hovering around 31 months.  That has got to give some folks in industry indigestion, as 180-day exclusivity can be forfeited if an ANDA sponsor fails to obtain tentative ANDA approval within 30 months of application submission.  FDA’s position has been that the Agency’s failure to timely grant tentative approval does not save an ANDA sponsor from forfeiture.

In 2010, we reported that OGD had quietly placed a hold on ANDA prior approval supplement reviews and approval actions until further notice (with some exceptions) to focus instead on original ANDA submissions (and minor amendments).  It is unclear the extent to which that hold reduced the ANDA backlog, but we are happy to report that we have heard that the hold has been lifted and supplement reviews and approval actions are progressing.  

In looking at OGD’s latest statistical figures, what is perhaps most concerning with the ANDA backlog is the tremendous recent growth of original ANDAs pending more than 180 days.  As shown in the table below, OGD started out 2010 with 1154 applications pending more than 180 days, and ended the year with 1816 applications pending more than 180 days.

 
What is so magical about 180 days?  Well, FDC Act § 505(j)(5)(A) states that “[w]ithin one hundred and eighty days of the initial receipt of an [ANDA] or within such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall approve or disapprove the application.”  Of course, FDA rarely ever meets that statutory requirement.

The tables above and below show that from 1997 to 2009, the number of original ANDAs pending more than 180 days fluctuated from less than 100 ANDAs to about 600 ANDAs.  Beginning in 2009, however, that number began to shoot up month-by-month.

Chemistry Manufacturing, and Controls (“CMC”) Supplements and Labeling Supplements pending more than 180 days have seen a similar rise, as the tables below show; however, FDA has noted that “abrupt changes in the level of pending [CMC] supplements are the result of global submissions to all applications held by a single firm.”

 
Why did things change beginning in 2009?  We don’t know exactly.  As shown below, the number of original ANDAs OGD receives each year (since 2005) has remained relatively stable.  (Interestingly, December is consistently the month in which OGD gets the greatest number of original ANDA submissions.)

Will new OGD leadership, additional funding, or generic drug user fees change the prospects for speedier ANDA reviews?  That remains to be seen. 

After serving as OGD Director for many years, Gary Buehler left FDA last year after being reassigned to the Office of Pharmaceutical Science to take an industry job.  Dr. Keith Webber has served as OGD’s Acting Director since Mr. Buehler’s reassignment.  FDA has been searching for a permanent Director.  We understand that the Agency has vetted several candidates and hopes to announce a permanent OGD Director in March. 

Although the 111th Congress considered omnibus appropriations bills that would have provided FDA (including OGD) with budget increases, ultimately, President Obama signed into law a stop-gap spending bill that kept FDA funded at Fiscal Year 2010 levels until early March.  With the current economic and political environments, it could be difficult to procure additional funding for FDA. 

That leaves us with generic drug user fees.  Last September, FDA held a public meeting to gather stakeholder input on the development of a generic drug user fee program.  FDA is still considering the various user fee proposals set forth by industry.  While folks are hopeful that a generic drug user fee system will provide greater review process predictability, user fees are not a panacea for addressing the ANDA backlog.  It will likely take several years after the implementation of a user fee system to bring the ANDA review queue under control, as new reviewers will have to be hired and trained.