By Kurt R. Karst –
Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (“GDUFA”) is expected to be introduced this week (and perhaps voted on by both the U.S. House of Representatives and the U.S. Senate). A draft of the FDA User Fee Corrections Act of 2012 appeared on a website maintained by the Office of the Clerk of the House earlier this week and would amend the FDC Act to address certain issues raised by language included in GDUFA.
Over the past month or so, there has been growing concern that come October 1, 2012 when GDUFA goes into effect, FDA will be unable to collect several GDUFA user fees because of the failure by Congress to pass an FDA Appropriations Act for Fiscal Year (“FY”) 2013. This concern was exacerbated when the Continuing Appropriations Resolution, 2013 (H.J. RES. 117) was passed by the House last week making continuing appropriations for FDA in FY 2013 at FY 2012 levels and without any provisions concerning the collection of user fees provided for under the FDA Safety and Innovation Act (“FDASIA”). In addition to creating a generic human drug user fee program, FDASIA also created a user fee program for biosimilars – the Biosimilars User Fee Act of 2012 – and renewed other existing user fee programs for drugs and medical devices (i.e., PDUFA and MDUFA). The FDA User Fee Corrections Act of 2012 is not intended to address other user fee statutes, which may be addressed in future legislation.
GDUFA, which is codified at FDC Act § 744A and § 744B, includes several provisions stating that the Type II Drug Master File (“DMF”) fee (FDC Act § 744B(a)(2)(E)), the Original ANDA and Prior Approval Supplement fees (FDC Act § 744B(a)(3)(C)), and the Finished Dosage Form and Active Pharmaceutical Ingredient fees (FDC Act § 744B(a)(4)(D)) are due by the later of two dates, including 30 calendar days after the enactment of an appropriations act providing for the collection and obligation of GDUFA user fees. (There are also other provisions concerning the crediting and availabilty of GDUFA user fees – i.e., FDC Act § 744B(i)(2)(C) – that mention an appropriations act). Take, for example, the statutory language applicable to the Type II DMF user fee, which states:
(ii) Limitation. – No fee shall be due under subparagraph (A) for a fiscal year until the later of –
(I) 30 calendar days after publication of the notice provided for in clause (i) or (ii) of subparagraph (C), as applicable; or
(II) 30 calendar days after the date of enactment of an appropriations Act providing for the collection and obligation of fees under this section.
Of course, if an appropriations act (or a continuing resolution for appropriations) is not enacted providing for the collection and obligation of GDUFA user fees, then the “later of” date will remain open.
The FDA User Fee Corrections Act of 2012 – acronymized as FDAUFCA and pronounced “fuh-doof-ka,” or perhaps more aptly “fuh-doh-f-ka” (with a Homer Simpson-esque emphasis on “doh”) – is intended to correct this problem by directing that the appropriations act language be disregarded. For example, the bill says the following with respect to the provision concerning Type II DMF user fees:
Notwithstanding section 744B(a)(2)(E)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(a)(2)(E)(ii)), the fee authorized under section 744B(a)(2) of such Act for fiscal year 2013 shall be due 30 calendar days after publication of the notice provided for in section 744B(a)(2)(C)(i) of such Act.
The bill includes similar language for the application and facility fee provisions in GDUFA. The one-time ANDA backlog fee does not appear to be affected by the lack of an FY 2013 appropriations act. Under the statute (FDC Act § 744B(a)(1)(D)), that fee “shall be due no later than 30 calendar days” after FDA publishes a notice in the Federal Register announcing the fee amount. The notice must be published by October 31, 2012.
FDA is moving full steam ahead with GDUFA implementation. In August, FDA published draft guidances on myriad GDUFA topics and that are primarily intended to notify industry of certain obligations that need to be timely completed (see our previous post here). On September 21, 2012, FDA will hold a public meeting to discuss GDUFA implementation.
- H.R. 6433 (The FDA User Fee Corrections Act of 2012) was introduced in and passed by the House without objection on September 19, 2012.