October 7, 2016
Authored and Edited by Kassandra M. Officer; Justin J. Hasford
On October 6, 2016, FDA published a final rule, “Abbreviated New Drug Applications and 505(b)(2) Applications,” which amends 21 C.F.R. Parts 314 and 320. Abbreviated New Drug Applications and 505(b)(2) Applications, 81(194) Fed. Reg. 69580-69658 (Oct. 6, 2016) (to be codified at 21 C.F.R. pts. 314, 320) (Final Rule). The Final Rule amended FDA’s regulations to implement certain provisions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and to facilitate compliance with and efficient enforcement of the FDCA. Final Rule at 69580. The Final Rule became effective on December 5, 2016, and applies to new submissions received by FDA on or after that date. Final Rule at 69632. This blog post highlights certain amendments but does not summarize all of the amendments implemented by the Final Rule.
The Final Rule amended the submission of patent information under 21 C.F.R. § 314.53 “to address overbroad or ambiguous use codes.” Final Rule at 69597-69600. In particular, the Final Rule requires that “if the method(s) of use claimed by the patent does not cover an indication or other approved condition of use in its entirety, the NDA holder’s use code must describe only the specific, approved method of use claimed by the patent” listed in the Orange Book for the drug product. Final Rule at 69643. Further, the NDA holder must identify “the specific section(s) and subsection(s) of the proposed labeling for the drug product that describes the methods of use claimed by the patent” listed in the Orange Book. Final Rule at 69643.
The Final Rule also amended the patent certification requirements under 21 C.F.R. §§ 314.60(f) and 314.96(d) to clarify the types of amendments that require certification or recertification. Final Rule at 69615-69616. In particular, the Final Rule requires an applicant to amend its ANDA or a 505(b)(2) application with an appropriate certification or recertification if the application is amended (1) to add a new indication or other condition of use; (2) to add a new strength; (3) to make other than minor changes in the product formulation; or (4) to change the physical form or crystalline structure of the active ingredient of the drug product. Final Rule at 69648, 65653. In its comments, FDA noted that changes in the product formulation are considered “minor” if the new formulation “is qualitatively (Q1) the same as the previous formulation (i.e., contains all of the same inactive ingredients) and quantitatively (Q2) essentially the same (i.e., each inactive ingredient differs by no more than plus or minus 5 percent from the previous formulation).” Final Rule at 69615.
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