WLF Legal Backgrounder Discusses PDUFA User Fee “Catch-22;” FDA’s ANDA “Non-Exception Excipient” Regulations and Policies Taken to Task

By Kurt R. Karst –

The Washington Legal Foundation is publishing a Legal Backgrounder authored by Hyman, Phelps & McNamara, P.C., attorneys Robert A. Dormer and Kurt R. Karst.  The article, titled “The Drug User Fee Catch-22,” argues that FDA should be more flexible in receiving and approving ANDAs for drug products whose formulations differ from that of the Reference Listed Drug (“RLD”). 

FDA’s regulations preclude the submission of an ANDA for certain drug product category inactive ingredient changes – so-called “non-exception excipients” – unless the Agency waives such regulations.  Historically, FDA policy limits granting waivers to cases in which an ANDA applicant seeks approval to market a drug product containing a non-exception excipient used in a discontinued, brand name RLD formulation that is not used in the currently-marketed RLD formulation.  As a result, manufacturers unable to obtain a waiver for a non-exception excipient change are effectively forced to submit a 505(b)(2) application.  While under earlier iterations of PDUFA such an application usually would not have qualified as a fee-paying 505(b)(2) application, the changes made to PDUFA under the 2007 FDA Amendments Act (“FDAAA”) require the payment of user fees for all FDC Act § 505(b) applications.  As we state in the article: 

In short, such applicants become the victims of a “Catch-22.”  That is,  FDA’s unnecessarily narrow non-exception excipient policies preclude the submission and approval of an ANDA, which is not subject to PDUFA user fees, and effectively force the submission of a 505(b)(2) application.  Meanwhile, Congress’ decision in passing FDAAA to make all 505(b)(2) applications fee-paying applications means that such applications are subject to user fees, which are quite substantial. . . . 

FDA could avoid a conflict between FDC Act § 505(j)(4)(H) and its exception excipient regulations by interpreting the list of excipients in its regulations as illustrative rather than as exhaustive, or by granting § 314.99(b) waiver requests for non-exception excipients outside of discontinued RLD formulation scenarios, provided there is sufficient information to show that an excipient in a proposed drug product is safe for use.  By doing so, a generic applicant would be able to submit an ANDA, rather that being effectively forced to submit a user fee-paying 505(b)(2) application, and could avoid the Catch-22 Congress created with FDAAA.

We published another WLF Legal Backgrounder in August 2005 discussing the applicability of PDUFA user fees to certain 505(b)(2) applications.  That issue was made moot with the enactment of FDAAA.