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12 October 2016Americas

FDA releases new rule on NDAs to reduce litigation

The US Food and Drug Administration (FDA) has released a final rule to reduce unnecessary litigation between brand owners and generic drugs producers.

In the new rule, made public on October 6, the FDA made changes to requirements surrounding Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs) submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA).

The change finalises a proposed rule, published on February 6, 2015, and contains a number of provisions related to the procedures and requirements for NDA owners to submit information about their patents to the FDA for inclusion in its Orange Book.

The new rule contains provisions on a process for resolving disputes between NDA owners and third parties regarding listed use codes for method-of-use patents.

A use code is an “NDA holder’s description of the specific approved method of use claimed by the patent”.

A 505(b)(2) NDA application contains full investigation reports of safety and effectiveness, “where at least some of the information relied upon by the applicant for approval of the NDA comes from investigations that were not conducted by or for the applicant”.

It is one of three forms of NDA.

The new FDA rule requires any parties disputing the accuracy or relevance of a use code published in the Orange Book to notify the FDA of the dispute, which will be followed by the FDA asking the NDA owner to confirm the accuracy of the use code within 30 days.

According to the FDA, the final rule has been issued to “implement title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which amended provisions of the FDCA that govern the approval of 505(b)(2) applications and ANDAs”.

The new rule, which covers provisions on the date of approval of NDAs and ANDAs, notification of commercial marketing, among other issues, will take effect on December 5.

In the official summary, the FDA said that the new rule is “intended to reduce unnecessary litigation, reduce delays in the approval of 505(b)(2) applications and ANDAs that are otherwise ready to be approved, and provide business certainty to both brand name and generic drug manufacturers”.

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