FDA Issues Direct Final Rule on Authorized Generic Reporting; Rule Implements FDAAA § 920

September 30, 2008

Section 920 of the FDA Amendments Act (“FDAAA”) amended the FDC Act to create new § 505(t) – “Database for Authorized Generic Drugs” – that requires FDA to compile and publish a complete list of all authorized generic drugs identified in annual reports submitted to the Agency since January 1, 1999. FDC Act § 505(t) defines an “authorized generic” as a drug listed in FDA’s Orange Book that was approved under FDC Act § 505(c) (i.e., a “full” 505(b)(1) NDA or 505(b)(2) application) and that “is marketed, sold, or distributed directly or indirectly to retail class of trade under a different labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark than the listed drug.” FDAAA requires that the authorized generic list be updated on a quarterly basis.  FDA first published its authorized generic list earlier this year.  Among other uses, this list is intended to assist the Federal Trade Commission as that agency moves ahead with its study of the competitive effects of authorized generics.

On September 29, 2008, FDA issued a direct final rule, as well as a companion proposed rule, to implement FDAAA § 920.  (If FDA receives any significant adverse comments on the Agency’s direct final rule, then FDA will withdraw the direct final rule and proceed to respond to comments under the proposed rule using the usual notice and comment procedures.  If no significant adverse comments are submitted to FDA, then the direct final rule will become effective on February 11, 2009.  Comments on both rules are due by December 15, 2008.)  Both rules would amend FDA’s regulations to require that NDA holders submit certain information in an annual report regarding authorized generic drugs.

Specifically, the proposals would amend FDA’s regulations at 21 C.F.R. §  314.3 to add the definition of an “authorized generic drug” (the same definition as in FDAAA § 920), and would amend FDA’s postmarketing reporting requirements to add 21 C.F.R. § 314.81(b)(2)(ii)(b) regarding the marketing of authorized generic drugs.  Under the new postmarketing reporting requirements, NDA holders must include information in their annual reports detailing: (1) the date each authorized generic entered the market; (2) the date each authorized generic ceased being distributed; and (3) the corresponding brand name drug.  FDA considers each dosage form and/or strength to be a different authorized generic drug that should be separately listed in an annual report.  Moreover, “[t]he first annual report submitted after implementation of this regulation must provide information regarding any authorized generic drug that was marketed during the time period covered by an annual report submitted after January 1, 1999.”  FDA also notes that when information is included in an annual report about an authorized generic drug, the Agency requires “that a copy of that portion of the annual report be sent to a central office in the agency that will compile the list and update it quarterly.” 

By Kurt R. Karst