April 5, 2012

Generic Exclusivity Forfeiture Fix Bill Introduced to Elevate OGD and Address ANDA Backlog

by Brian Malkin

Thumbnail image for Thumbnail image for house of representatives.jpgOn March 29, Rep. Frank Pallone, Jr. (D-NJ) introduced in the House a Bill aimed at raising the reporting level of the Office of Generic Drugs ("OGD") in FDA and implementing a temporary "fix" of the 180-day exclusivity forfeiture situation affecting applicants unable to obtain tentative approvals within 30 months from filing. The Bill (H.R. 4332), co-sponsored by Rep. Brett Guthrie (R-KY) is called, "Generic Drug Application Review Fairness Act of 2012".

First, the Bill would elevate OGD to a "separate office" within the Center for Drug Evaluation and Research ("CDER") with direct reporting authority to the Director of CDER, currently Janet Woocock, M.D. OGD is presently part of the Office of Pharmaceutical Science. If enacted, this change would follow a new trend to elevate certain groups within CDER, presumably to empower the separate offices more than in the current hierarchy. A recent elevation from "Division" to "Office", for example, occurred last year for the former Division of Drug Marketing, Advertising and Communications ("DDMAC"), now known as the Office of Prescription Drug Promotion ("OPDP") within the Office of Medical Policy. As proposed, OGD would then be on equal hierarchical par with the Office of New Drugs ("OND") and presumably have more clout when it comes to issues such as resources, funding, or scientific decisions within its purview, such as bioequivalence.

As a temporary fix of OGD's backlog of abbreviated new drug applications ("ANDAs"), the Bill initially would provide 60 months for first applicants with 180-day exclusivity eligibility to obtain a tentative approval. The current forfeiture provision, enacted by the in 2003 under the Medicare Prescription Drug, Improvement, and Modernization Act ("MMA") states that a first applicant to submit a "Paragraph IV" patent challenge will forfeit its 180-day exclusivity in the following situation:

The first applicant fails to obtain tentative approval of the application within 30 months after the date on which the application is filed, unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed.
21 U.S.C. § 355(j)(5)(D)(i)(IV).

This fix would apply, however, only for ANDAs filed "on or after the day that is 30 months prior to the date of enactment of this Act" AND no Paragraph IV patent challenge was before such day. ANDAs that do not fall under this provision would be governed by the current provision. Over time the 60 month duration is curtailed yearly until it returns to 30 months on October 1, 2017, presumably reflecting the expected reduction in ANDA review times if the Generic Drug User Fee Agreement ("GDUFA") is enacted, which we reported on here.

The Bill comes in time to rescue certain first applicants forced to wonder as they approach the 30-month window for tentative approval whether they will be found to forfeit or if FDA will find a loophole to determine that there has been a "change in or a review of the requirements for approval." FDA now reports that there is a 30-plus-month median review time for ANDAs, compared to a reported 17-month median review time in 2003 when the MMA was enacted.

Another potential loophole has been the application of a newer provision enacted in the Food and Drug Administration Amendments Act of 2007 ("FDAAA") that provided the 30-month period could be extended if certain citizen petitions were filed during the review of the ANDA that caused a delay in the tentative approval:

If the filing of an application [ANDA] resulted in the first-applicant status under subsection (j)(5)(i)(IV) [Paragraph IV ANDA] and approval of the application was delayed because of a petition [21 U.S.C. § 505(q)-type petition, see our blog here for more on this], the 30-month period under such subsection is deemed to be extended by a period of time equal to the period beginning on the date on which the Secretary received the petition and ending on the date of final agency action on the petition (inclusive of such beginning and ending dates), without regard to whether the Secretary grants, in whole or in part, or denies, in whole or in part, the petition.
21 U.S.C. § 355(q)(1)(G).

In many instances, FDA's determination for whether the 30-month period had been extended by a 505(q) petition under FDAAA or removed entirely by the provisions in the MMA has been cryptic and difficult to predict for both first applicants hoping to retain their exclusivity and subsequent applicants hoping for a forfeiture event. In mid-March, for example, FDA determined that there was no forfeiture for Teva's first Paragraph IV generic for Avapro® (irbesartan tablets) because:

Toward the end of the 30-month period described in section 505(j)(5)(D)(i)(IV), FDA changed the approval requirements for Teva's proposed product. As a result, Teva was required to perform additional testing and include an additional drug substance specification prior to approval.
Yet in this case, a subsequent applicant had filed a citizen petition asserting that there was no public information (and presumably no nonpublic information that the subsequent applicant was aware of as a subsequent applicant) to suggest that FDA had changed the approval requirements.

On the same day the Bill was introduced, it was referred to the House Energy and Commerce Committee. We will update you with any developments whether this Bill gains some traction in Congress, which we expect could coincide with GDUFA.