Source: http://www.fdalawblog.net/2012/01/fda-sends-user-fee-pacts-to-congress-proposed-generic-drug-user-fee-statute-includes-some-unique-pro/
Timestamp: 2020-03-29 15:33:55
Document Index: 250662563

Matched Legal Cases: ['§ 505', '§ 744', '§ 505', '§ 744', '§ 744', '§ 502']

Last week, FDA Commissioner Margaret A. Hamburg, M.D. announced that the Agency sent to Congress packages for three user fee programs, including proposed statutory language for the fifth iteration of the Prescription Drug User Fee Act (“PDUFA V”), and two new user fee statutes – the Generic Drug User Fee Amendments of 2012 (“GDUFA”) and the Biosimilars User Fee Act of 2012 (“BSUFA”). FDA previously announced the proposed performance goals and procedures (Fiscal Years 2013 through 2017) for PDUFA V, GDUFA, and BSUFA (here, here, and here), which we reported on here, here, and here. Noticeably absent from FDA’s submission is proposed statutory language and performance goals and procedures for the next iteration of the Medical Device User Fee and Modernization Act (“MDUFMA”). According to press reports (see here), FDA and industry are still haggling over some issues. The House Energy and Commerce Committee has scheduled three hearings for February 2012 to consider each of the four user fee programs (see here, here, and here).
There are proposed to be four types of fees in two categories – application fees and facility fees. Application fees, which account for 30% of total fee revenue each FY, include an original ANDA fee and Prior Approval Supplement (“PAS”) fee (one half of the ANDA fee) (both accounting for 24% of the total revenue amount), and a Type II Drug Master File (“DMF”) “first reference fee” (6% of total revenue amount). There is also a one-time (FY 2013) ANDA backlog fee for ANDAs pending on October 1, 2012. That fee will be calculated by dividing $50 million by the number of ANDAs in the backlog, which as of January 1, 2012, was at 2,696 ANDAs. (There was a record 210 original ANDA submissions to FDA in December alone, historically the highest volume month of submission. A total of 946 original ANDAs were submitted to FDA in 2011.) The number of ANDAs in the backlog on October 1, 2012 may increase or decrease from the current backlog number as companies decide whether or not to withdraw applications (or perhaps play a game of chicken with other ANDA sponsors).
A facility fee, which accounts for 70% of total fee revenue each FY, must be paid by both Finished Dosage Form (“FDF”) and Active Pharmaceutical Ingredient (“API”) manufacturers. FDF facility fees account for 80% of facility fee revenue (56% of the total revenue amount), and API facilities account for 20% of facility fee revenue (14% of the total revenue amount). There is “a modest fee differential” of not less than $15,000 and not more than $30,000 for foreign FDF and API facilities “reflecting the added costs of overseas inspection.”
Failure to Pay User Fees. The penalties for failing to pay GDUFA fees are particularly harsh under the proposed statutory language.
Failure to pay the ANDA backlog fee will result in placing the ANDA sponsor on an arrears list, “such that no new ANDAs or supplement submitted on or after October 1, 2012 from that person, or any affiliate of that person, will be received within the meaning of [FDC Act § 505(j)(5)(A)] as implemented in [FDA] regulations, until such outstanding fee is paid.” Proposed FDC Act § 744G(g)(1) (emphasis added).
Failure to pay the required application fee within 20 calendar days of the due date will result in the application not being received (FDC Act § 505(j)(5)(A)) until the fee is paid. ANDA receipt date is, of course, particularly important when 180-day exclusivity is at stake. And the proposed statute recognizes this at § 744G(o), which states:
The penalties in [proposed FDC Act § 744G(g)(4)] shall apply until the [facility] fee . . . is paid or the facility is removed from all generic drug submissions that refer to the facility.
Proposed FDC Act § 502(aa) (Section 106 of GDUFA) would amend the statute to state that a drug shall be deemed to be misbranded: