Guidance for generic drugs

The U.S. Food and Drug Administration (FDA) has announced that a Guidance for Industry entitled "Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003: Questions and Answers" is being made available online (PDF).

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) made significant changes to the generic drug approval process designed to provide more certainty to the generic drug approval process and help get generic drugs to the market more quickly. As indicated in our March 3, 2004, Federal Register notice (69 FR 9982), FDA has been considering what steps to take in light of the passage of the MMA. This guidance is one step.

As directed by the MMA, this document provides guidance on the definition of a listed drug. A listed drug is required to be referenced in a generic application and indicates the approved drug the generic company is relying upon for approval of its version of the product. The guidance is intended to clarify when a change to a generic application should reference a different listed drug from the listed drug referenced in the original generic application, and thus be made through the submission of an entirely new application that encompasses the desired change.

The document also provides guidance to industry on certain sections of the MMA that significantly change provisions of the Food, Drug, and Cosmetic (FD&C) Act that were originally added by the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (Hatch-Waxman).

These provisions affect the Act's 30-month stay of approval of a generic or section 505(b)(2) application upon the filing of a patent infringement suit and the 180-day exclusivity periods available to the first generic applicants to challenge innovator patents.

This guidance clarifies changes made by the MMA with respect to (1) the availability and termination of 30-month stays of approval of generic and section 505(b)(2) applications, (2) requirements for notice of patent certifications (paragraph IV certifications) by generic and section 505(b)(2) applicants, and (3) the 180-day exclusivity for "first" generic applicants. The guidance also explains the various effective dates that apply to the MMA's generic drug provisions.