Quicker Generic Approvals, Less Litigation Among Goals of FDA Rule


A new final rule on generic drug applications aims to speed approvals and cut unnecessary litigation, the FDA said Oct. 5.

The rule (RIN: 0910-AF97) implements portions of a 2003 Medicare drug law and governs approval of abbreviated new drug applications (ANDAs) and 505(b)(2) applications. ANDAs are used for generic drug approvals, while 505(b)(2) is a type of abbreviated pathway that allows the Food and Drug Administration to rely on data not developed by the applicant for approval of a new drug application. The rule, which was published Oct. 6 in the Federal Register, also governs the submission of certain drug patent information.

The final rule comes out as policymakers are focusing on concerns about drug costs and the lack of cheaper competition, including generics, for certain products.

Gaby L. Longsworth, a patent attorney with Sterne Kessler Goldstein & Fox in Washington, told me that the most significant provision in the final rule is that it “clarifies requirements to address overbroad and ambiguous use codes that may delay approval of generic drugs.”

A use code is the new drug application holder's description of the specific approved method of use claimed by the patent required for publication in the FDA's Orange Book. The Orange Book, formally titled Approved Drug Products with Therapeutic Equivalence Evaluations, lists patents submitted to the agency by branded drug companies as covering a branded drug or its use.

The FDA said the clarification in the final rule is intended to help the agency implement statutory provisions that permit 505(b)(2) and ANDA applicants to omit protected conditions of use from their labeling and obtain approval for conditions of use that aren't covered by unexpired patents or exclusivity.

“The revisions to the use code provisions are long overdue, but it remains to be seen whether they will have any teeth,” Longsworth said.

My full article on the rule is at http://src.bna.com/jc6.

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