Pallone Bill Takes an “Oscar Rogers Approach” to 180-Day Exclusivity Forfeiture and FDA’s Office of Generic Drugs: FIXIT!

By Kurt R. Karst –      

Fans of Saturday Night Live know popular Weekend Update correspondent Oscar Rogers (played by Kenan Thompson) and his three-step approach to addressing important issues of the day:  Step 1: Fix. Step 2: It. Step 3: FIXIT!  That approach sums up the “Generic Drug Application Review Fairness Act of 2012” (H.R. 4332), which Rep. Frank Pallone, Jr. (D-NJ) introduced last week.  The bill would make two important changes to the law – one with respect to 180-day exclusivity forfeiture, and another with respect to FDA’s Office of Generic Drugs (“OGD”).

180-Day Exclusivity Forfeiture.  Section 2 of H.R. 4332 deals with FDC Act § 505(j)(5)(D)(i)(IV), which is one of the six 180-day exclusivity forfeiture provisions added to the FDC Act by Title XI of the Medicare Modernization Act (“MMA”).  Under FDC Act § 505(j)(5)(D)(i)(IV), 180-day exclusivity eligibility is forfeited if:

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.

The 2007 FDA Amendments Act clarified FDC Act § 505(j)(5)(D)(i)(IV), such that if “approval of the [ANDA] was delayed because of a [citizen] petition, 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) . . . .” (FDC Act § 505(q)(1)(G)). 

FDA has applied and discussed FDC Act § 505(j)(5)(D)(i)(IV) on many, many occassions, including in recent Citizen Petition responses – see, e.g., Docket No.  FDA-2011-P-0486 and Docket No. FDA-2010-P-0632.  Indeed, according to our data (see our popular 180-Day Exclusivity Tracker), FDC Act § 505(j)(5)(D)(i)(IV) has resulted in more forfeitures of exclusivity than any other forfeiture provision (probably even when combined).

FDA has very strictly and narrowly interpreted FDC Act § 505(j)(5)(D)(i)(IV), such that even an act of Mother Nature shutting down the Federal government and preventing FDA from granting tentative approval on the 30-month ANDA submission anniversary date has resulted in a forfeiture of 180-day exclusivity eligibility (see our “Snowmageddon” post here).  And FDA’s growing median ANDA approval time has not helped either.  With a median ANDA approval time of about 33 months today (about 17 months in 2003 when the MMA was enacted) and an ANDA backlog of about 2,800 applications at the end of February 2012, forfeitures are a real concern in the generic drug industry.  Then there’s FDA’s interpretation of FDC Act § 505(j)(5)(D)(i)(IV) that could result in an automatic forfeiture of 180-day exclusivity eligibility.  As we previously reported, FDA interprets FDC Act § 505(j)(5)(D)(i)(IV) such that when an ANDA sponsor who amends a long-pending ANDA to include a Paragraph IV certification to an Orange Book-listed patent and qualifies as a “first applicant,” that sponsor may simultaneously forfeit 180-day exclusivity eligibility for failure to obtain timely tentative approval because FDA counts 30 months from the ANDA submission date and not from the first Paragraph IV certification date. 

The Generic Drug Application Review Fairness Act of 2012 would go a long way to address some of the concerns the generic drug industry has had with FDC Act § 505(j)(5)(D)(i)(IV).  It would amend this section of the law to change the 30-month period to 60 months and to address FDA’s interpretation that could result in an automatic forfeiture of exclusivity.  Specifically, FDC Act § 505(j)(5)(D)(i)(IV) would be amended as follows:

(IV) FAILURE TO OBTAIN TEN TATIVE APPROVAL.—The first applicant fails to obtain tentative approval of the application within 60 months after the date on which—

(aa) the application is filed and initially contains a certification described in paragraph (2)(A)(vii)(IV), or

(bb) the application is amended to first contain such a certification,

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 so filed or amended. [(Emphasis added)]

FDC Act § 505(q)(1)(G), which extends the tentative approval period for certain citizen petitions, would also be amended to remove reference to 30-months. 

Amended FDC Act § 505(j)(5)(D)(i)(IV) would apply “only with respect to an application that is filed under[FDC Act § 505(j)] on or after the day that is 30 months prior to the date of the enactment of [H.R. 4332],” and “only if no [Paragraph IV certification] was made before such day with respect to the listed drug . . . .”  ANDAs submitted to FDA prior to the 30-month date described in the previous sentence and that on that date contained a Paragraph IV certification would be subject to the unamended version of FDC Act § 505(j)(5)(D)(i)(IV), thus setting up a pre-and post-Generic Drug Application Review Fairness Act regime (somewhat akin to the current pre- and post-MMA 180-day exclusivity regime).

Giving a nod to the Generic Drug User Fee Amendments (“GDUFA”) – see our previous post here – which is expected to be enacted later this year, H.R. 4332 would incrementally reduce the 60-month tentative approval period to 54 months in Fiscal Year 2013, 48 months in Fiscal Year 2014, 42 months in Fiscal Year 2015, 36 months in Fiscal Year 2016, and back to 30 months for Fiscal Year 2017 – the last year covered by “GDUFA I.”  The 60- to 30-month periods would apply to ANDAs submitted to FDA in that particular Fiscal Year that initially contain, or that are amended to initially contain, a Paragraph IV certification qualifying a sponsor as a “first applicant” eligible for 180-day exclusivity.

The Office of Generic Drugs.  Section 3 of H.R. 4332 would amend the FDC Act to add  § 505(j)(11) to elevate OGD within FDA’s Center for Drug Evaluation and Research (“CDER”):

(11) OFFICE OF GENERIC DRUGS.—

(A) OFFICE.—The Secretary shall maintain the Office of Generic Drugs as a separate office within the Center for Drug Evaluation and Research of the Food and Drug Administration.

(B) REPORTING.—The Director of the Office of Generic Drugs shall report directly to the Director of the Center for Drug Evaluation and Research.

OGD is currently housed within the Office of Pharmaceutical Science (“OPS”) (headed by Helen N. Winkle).  H.R. 4332 would take OGD out of OPS and make it an office on par with the Office of New Drugs.  It would also give the OGD Director (currently Keith Webber, Ph.D.) direct reporting to the CDER Director (currently Janet Woodcock, M.D.).