After 13 years of waiting, the FDA has finalized its regulations implementing portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (P.L. 108-173), which amended provisions of the federal Food, Drug & Cosmetic Act (FDC Act) relating to the approval of abbreviated new drug applications (ANDAs/generic applications) and section 505(b)(2) new drug applications (NDAs). As stated in its Proposed rule (80 FR 6801, February 6, 2015), the FDA intends that its final regulations will reduce unnecessary litigation, reduce delays in the approval of 505(b)(2) drug applications and ANDAs that are otherwise ready to be approved, and provide business certainty to both brand name and generic drug manufacturers (see FDA finally takes action to implement a 2003 law affecting generic and 505(b)(2) drug applications, February 6, 2015). The regulations are also designed to codify current FDA practice and thereby promote transparency (Final rule, 81 FR 69580, October 6, 2016).
Specifically, the Final rule implements portions of Title XI of the MMA (Access to Affordable Pharmaceuticals) that pertain to: (1) the provision of notice to each patent owner and the NDA holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; (2) the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; (3) the submission of amendments and supplements to 505(b)(2) applications and ANDAs; and (4) the types of bioavailability and bioequivalence data that can be used to support these applications.
Response to FTC concerns. Title XI of the MMA was designed to address Federal Trade Commission concerns that anticompetitive strategies may delay access to generic drugs by limiting the availability of 30 month stays of approval on 505(b)(2) drug applications and ANDAs that are otherwise ready to be approved by the FDA, and by establishing conditions under which a first ANDA applicant would forfeit the 180-day exclusivity period because the approval of subsequent ANDAs would no longer be blocked.
Section 505(b)(2) applications and ANDAs. A 505(b)(2) application, named for section 505(b)(2) of the FDC Act (21 U.S.C. §355(b)(2)), is a NDA that must contain full reports of investigations of safety and effectiveness, and where at least some of the information required for approval comes from studies not conducted by the applicant and for which the applicant has not obtained a right of reference or use (such as published literature or an FDA finding of safety and effectiveness for one or more listed drugs).
An ANDA is an application for a duplicate (or generic version) of a previously approved drug that is submitted under the abbreviated approval pathway described in section 505(j) of the FDC Act (21 U.S.C. §355(j)). An ANDA must contain information to show that the proposed product is the same as a previously approved drug with respect to active ingredient, dosage form, route of administration, strength, labeling, and conditions of use, among other characteristics.
The 505(b)(2) application and ANDA approval pathways were enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417) (Hatch-Waxman Amendments). The Hatch-Waxman Amendments were part of a Congressional effort make available more low cost generic drugs by combining a generic drug approval procedure with new incentives for drug development in the form of marketing exclusivity and patent term extensions.
Changes to 505(b)(2) applications and ANDAs. The Final rule amends the FDA’s regulations regarding 505(b)(2) applications and ANDAs not only to facilitate compliance with the FDC Act, but to clarify and update these regulations based on recent court decisions and the FDA’s practical experience implementing provisions related to the approval of 505(b)(2) applications and ANDAs.
For example, the FDA clarifies the requirements for the NDA holder's description of the specific approved method of use claimed by the patent (the "use code") required for publication in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (commonly known as the Orange Book) to address overbroad or ambiguous use codes that may delay approval of generic drugs. This clarification is intended to facilitate the FDA's implementation of the statutory provisions that permit 505(b)(2) and ANDA applicants to omit ("carve out") protected conditions of use from labeling and obtain approval for conditions of use that are not covered by unexpired patents or exclusivity. The FDA is also revising the regulations to codify the types of court decisions and other actions that will terminate a 30-month stay of approval on a 505(b)(2) application or ANDA.
Additional provisions. The Final rule also sets forth the requirements for the submission of patent information; the timing of submission of patent information; the correction or change of patent information; the timing, content and method for sending notice of paragraph IV certification; amending patent certifications; limitations on the submission of certain amendments and supplements to 505(b)(2) applications or ANDAs; content and date of approval of 505(b)(2) applications or ANDAs, and notification of commercial marketing and court actions.
The provisions of the Final rule are effective December 5, 2016.
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