Animal Drug User Fee Law Awaiting Enactment; New Law Reauthorizes ADUFA, Creates Generic Animal Drug User Fees, and Makes Technical Corrections to FDAAA

August 6, 2008

In the coming days, President Bush is expected to sign into law H.R. 6432 – the Animal Drug User Fee Amendments of 2008.  The new law reauthorizes and amends the Animal Drug User Fee Act (“ADUFA”) through Fiscal Year (“FY”) 2013, creates a new law for generic animal drug user fees (the Animal Generic Drug User Fee Act of 2008), and makes a couple of technical changes to the FDA Amendments Act (“FDAAA”), which was enacted in September 2007. 

ADUFA was first enacted in 2003 (Pub. L. No. 108-130).  Like its human drug counterpart, the Prescription Drug User Fee Act (“PDUFA”), ADUFA authorizes FDA to collect user fees to enhance the performance of the drug review process and ensure that new drugs are safe and effective. Under both laws, FDA has agreed to certain performance goals to review and act on applications. While human drug products under PDUFA are subject to three types of fees (application, establishment, and product fees), animal drug products approved under ADUFA are subject to four types of fees – application, product, establishment, and sponsor fees.  FDA’s ADUFA website provides additional information on the law.

The House Report accompanying H.R. 6432 details the changes made to ADUFA I by ADUFA II.  Among other things, the new law requires animal drug sponsors to submit annual reports to FDA on certain products containing antimicrobial active ingredients, and requires FDA to make summaries of the reports publicly available.  The information is intended to support FDA’s continuing efforts to address antimicrobial resistance.

Unlike PDUFA, which does not cover human generic drug products approved under Abbreviated NDAs (“ANDAs”), H.R. 6432 establishes a generic animal drug user fee system under the Animal Generic Drug User Fee Act of 2008 (“AGDUFA”).  Under AGDUFA, generic animal drug applicants are subject to three types of fees – application, product, and sponsor fees.  The enactment of AGDUFA will fulfill the Bush Administration’s FY2009 budget proposal to create such a law.  It is possible that the creation of a user fee system for generic animal drugs might lead to the creation of such a system for generic human drugs.  Indeed, the Bush Administration’s FY2008 and FY2009 budget proposals recommended the creation of generic human drug user fees.  While it is unlikely that a generic human drug user fee system will be proposed in Congress this year, it could happen once the 111th Congress convenes in January 2009.

In addition to handling animal drug user fees, H.R. 6432 makes a few technical corrections to FDAAA.  FDAAA added FDC Act § 505(q) concerning certain types of citizen petitions that could delay generic competition.  H.R. 6432 clarifies that “[c]onsideration of the petition shall be separate and apart from review and approval of any application.”  FDA has been criticized for its implementation of FDC Act § 505(q), and, in particular for not decoupling ANDA approval from responding to an applicable petition that could delay generic competition.  Despite this criticism, FDA has in at least one post-FDAAA instance decoupled ANDA approval and petition response.  Specifically, FDA approved ANDAs for generic CAMPTOSAR (irinotecan HCl) Injection in February 2008, notwithstanding a January 29, 2008 petition requesting that FDA stay further ANDA approvals.  FDA formally responded to the petition late last month.  H.R. 6432 also makes minor clarifying amendments to the clinical trial registry and results data bank provisions of Public Health Service Act § 402(j) added by FDAAA § 801.

An earlier version of the so-called “FDAAA fix” language that was circulated on Capitol Hill would have made more significant changes to FDAAA, including adding a provision creating Hatch-Waxman benefits for “old” antibiotics – i.e., antibiotic active ingredients (and derivatives of such ingredients) included in an application submitted to FDA for review or approved prior to the enactment of the 1997 FDA Modernization Act on November 21, 1997.  The proposal circulated on Capitol Hill mirrored § 1111 of the Staff Agreement version of FDAAA.  Section 1111 was stripped from FDAAA hours before the House of Representatives voted on the bill, reportedly due to costs concerns.  The same provisions in a proposed FDAAA fix addition to H.R. 6432 were removed, but for reasons that are unclear.

By Kurt R. Karst    

Categories: Drug Development