FDA Finalizes Authorized Generics Reporting Rule; Electronic Submissions Will be Permitted and Eventually Required

By Kurt R. Karst –      

On July 28, 2009, FDA will publish a final rule amending the Agency’s regulations requiring that NDA holders submit in annual reports certain information to the Agency concerning authorized generics.  The regulations, which were first proposed in September 2008 – both as a proposed rule and as a direct final rule (that was later withdrawn after FDA received significant adverse comment) – implement Section 920 of the FDA Amendments Act (“FDAAA”).  FDAAA § 920 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 in June 2008.  Among other uses, this list is intended to assist the Federal Trade Commission (“FTC”) as that agency moves forward to complete its study of the competitive effects of authorized generics.  As we previously reported, in June 2009, the FTC published an interim report on authorized generic drugs.  The report provides the results of the FTC’s preliminary data analysis on the short-term effects of authorized generics on competition during 180-day exclusivity.

The authorized generics final rule, which goes into effect in six months, amends FDA’s regulations at 21 C.F.R. § 314.3(b) to add the following definition of an “authorized generic drug” that is substantially identical to that in FDC Act § 505(t):

Authorized generic drug means a listed drug, as defined in this section, that has been approved under section 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with 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 trademark that differs from that of the listed drug.

The final rule also amends FDA’s postmarketing reporting requirements to add 21 C.F.R. § 314.81(b)(2)(ii)(b) to require NDA holders to include in their annual reports information 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, the 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.” 

The final rule makes some changes to the proposed rule, particularly with regard to the electronic submission of authorized generic information.  Specifically, FDA states in the final rule that:

After considering the comments, we have concluded that it is appropriate to make a revision to the proposed rule to permit e-mail submission of the required information in addition to regular mail, including courier delivery.  The final rule revises proposed 314.81(b)(2)(ii)(b) to allow NDA holders to send the required information to the Authorized Generics electronic mailbox at AuthorizedGenerics@fda.hhs.gov with Authorized Generic Submission indicated in the subject line.

We also revised the last line of that section to clarify when separate submission of the authorized generics information is required by this rule.  When information is included in an annual report about an authorized generic drug, the final rule 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 of authorized generic drugs and update it quarterly.  At such time as FDA requires electronic submission of annual reports through a system that allows for the extraction of relevant information from annual reports, separate submission of the information will no longer be required.

Based on FDA’s historical review of annual reports, the Agency estimates that approximately 60 NDA sponsors will submit about 400 annual reports containing  authorized generic information required to be reported under new 21 C.F.R. § 314.81(b)(2)(ii)(b).