Reports Detail FDA’s 505(q) Citizen Petition Response Track Record; Section 505(q) May Have Some Unintended Consequences, FDA Says (Part II)

By Kurt R. Karst –      

Yesterday, we posted on FDA’s report to Congress on encouraging the early submission of citizen petitions covered by FDC Act § 505(q).  Today, we take a look at the two annual reports FDA has submitted to Congress detailing the Agency’s experience with implementing FDC Act § 505(q).

Both the Fiscal Year 2008 report and the Fiscal Year 2009 report, sent to Congress on April 28, 2009, and July 29, 2010, respectively, are required by FDC Act § 505(q)(3).  According to that provision, each annual report to Congress must specify: “(A) the number of applications that were approved during the preceding 12-month period; (B) the number of such applications whose effective dates were delayed by petitions referred to in paragraph (1) during such period; (C) the number of days by which such applications were so delayed; and (D) the number of such petitions that were submitted during such period.”  The stats for each of these categories, by fiscal year (although the Fiscal Year 2008 report covers the period of September 27, 2007 through September 30, 2008), are as follows:

The number of ANDAs and 505(b)(2) applications that were approved during the preceding 12-month period.

Fiscal Year 2008 – 476 ANDAs and 31 505(b)(2) applications approved

Fiscal Year 2009 – 489 ANDAs and 35 505(b)(2) applications approved

The number of such ANDAs and 505(b)(2) applications whose effective dates were delayed by a 505(q) petition during the preceding 12-month period.

Fiscal Year 2008 – The effective dates of 2 ANDAs were delayed by the same petitions (submitted by another ANDA sponsor);

Fiscal Year 2009 – The effective date of one ANDA was delayed by a petition

The number of days by which such ANDAs and 505(b)(2) applications were so delayed.

Fiscal Year 2008 – Each of the 2 delayed ANDAs was delayed by 138 days 

Fiscal Year 2009 – The one delayed ANDA was delayed by 27 days

The number of 505(q) petitions that were submitted during the preceding 12-month period.

Fiscal Year 2008 – 21 505(q) petitions

Fiscal Year 2009 – 31 505(q) petitions

And what about FDA’s ability to meet the statutory 180-day timeframe to respond to 505(q) petitions?  FDA does not provide that information for the Agency’s Fiscal Year 2008 report, but according to the Fiscal Year 2009 report, “FDA responded to 23 petitions subject to section 505(q) within the 180-day statutory timeframe.”  That would appear to mean that FDA failed to meet the timeframe for 8 of the covered petitions.  FDA’s pursuit to timely respond to 505(q) petition is apparently causing a drain on Agency resources.  According to the Fiscal Year 2009 report, “FDA has met the 180-day timeframes for these petitions by redirecting efforts previously directed to other work.” 

After two year of experience in implementing section 505(q), FDA “believes it may still be too early to make a determination as to whether section 505(q) is effectively discouraging petitions submitted with the primary purpose of delaying approval of an ANDA or 505(b)(2) application,” but the Agency notes that “the number of 505(q) petitions submitted during fiscal year 2009 increased by more than 47 percent over the number submitted during the first reporting period.”  By our count, the number of 505(q) petitions submitted in Fiscal Year 2010 is roughly the same as the number of petitions submitted in Fiscal Year 2009. 

FDA wraps up the Fiscal Year 2009 report by noting some “areas of concern.”  Specifically:

FDA continues to receive 505(q) petitions from ANDA and 505(b)(2) applicants and not solely from innovator companies;

FDA is seeing an increase in petitions for reconsideration pursuant to 21 CFR 10.33, requiring the agency to readdress issues that have already been decided; and

FDA has also received serial 505(q) petitions frequently from the same petitioner about a specific drug product or class of drug products, sometimes resulting in several petition responses about different aspects of the same product.

A couple of these concerns are carryovers from FDA’s Fiscal Year 2008 report and from the Agency’s initial report to Congress on encouraging the early submission of citizen petitions covered by FDC Act § 505(q), but could, according to FDA, become trends that  upset the primary purpose of FDC Act § 505(q).  “If these areas of concern become trends,” FDA says in the 2009 report, “they may undermine the goal of discouraging the submission of petitions that do not raise valid scientific issues and have the effect of improperly delaying approval of ANDAs or 505(b)(2) applications.”

FDC Act § 505(q) is not one of those statutory provisions, like the Prescription Drug User Fee Act or the Best Pharmaceuticals for Children Act, that is up for reauthorization at the end of Fiscal Year 2012.  Nevertheless, we would not be surprised if there is an effort to amend FDC Act § 505(q) to address some of FDA’s and industry’s concerns with the provisions and to make them more effective.  Despite the apparent drain on FDA resources, we think FDC Act § 505(q) has, if nothing else, provided more timely advice and greater transparency into FDA’s thinking on important Hatch-Waxman issues.