“New” CDER Exclusivity Board Focuses on Clarity and Consistency of Exclusivity Decisions

By Kurt R. Karst –

FDA recently announced that the Agency has established within the Center for Drug Evaluation and Research (“CDER”) an Exclusivity Board “to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency of decisions.”  “The CDER Exclusivity Board will oversee certain exclusivity determinations, including whether and what type of exclusivity should be granted and the appropriate scope of exclusivity grants,” according to the announcement.  Furthermore, says the announcement,

The Board will focus on 5-year new chemical entity (NCE) exclusivity, 3-year new clinical trial exclusivity, and exclusivity for biological products.  The Board will not review or make recommendations with respect to all exclusivity determinations in these areas, but will assist the Center in resolving certain matters, including issues that arise in the context of specific requests for exclusivity.

The Board generally will not review 180-day generic drug exclusivity, 7-year orphan drug exclusivity, or 6-month pediatric exclusivity, but it will communicate with other groups within FDA responsible for addressing these exclusivity issues, as appropriate. The Board also may evaluate and make recommendations regarding CDER’s policies and practices relating to exclusivity and maintain records of exclusivity determinations.

Although FDA only recently announced the creation of the CDER Exclusivity Board, it has been around for several months.  Indeed, back in April 2012, the Board rendered a decision with respect to the availability of 3-year exclusivity for an NDA supplement for VANCOCIN (vancomycin HCl) Capsules (NDA No. 050606).  The substance of that decision denying 3-year exclusivity showed up in an FDA Citizen Petition decision and is currently being litigated.  The Board was also almost certainly involved in the May 29, 2012 decision to rescind 5-year NCE exclusivity for TORISEL (temsirolimus) Injection (NDA No. 022088) and in the May 29, 2012 decision to deny 5-year NCE exclusivity for VERAMYST (fluticasone furoate) Nasal Spray (NDA No. 022051).

The CDER Exclusivity Board was likely created in the wake of a February 2009 lawsuit against FDA over the Agency’s decision to grant NCE exclusivity for VYVANSE (lisdexamfetamine dimesylate) Capsules (NDA No. 021977).  (FDA ultimately issued a letter decision affirming the grant of NCE exclusivity, and both the DC District Court and the DC Circuit Court ruled in FDA’s favor.)  During the course of that litigation, FDA acknowledged that the Agency had mistakenly denied 5-year NCE exclusivity for another drug – EMEND (fosaprepitant dimeglumine) for Injection (NDA No. 022023) – and issued a letter decision that fosaprepitant dimeglumine should have been classified at the time of approval as an NCE and awarded 5-year exclusivity instead of 3-year exclusivity.  As we previously discussed, in each of these decisions FDA articulated a structure-centric interpretation of “active moiety” (rather than an activity-based interpretation) under which a drug is classified as an NCE regardless of which portions of the active ingredient contribute to the overall therapeutic effect of the drug.

FDA’s announcement does not discuss the composition of the CDER Exsclusivity Board; however, we understand that the Board is composed of members from various FDA components.  These FDA components include the Office of Chief Counsel, the Office of New Drugs, the Office of Regulatory Policy, and the Office of Generic Drugs.  It is possible that the Board may bring other FDA components as issues, such as biologics exclusivity, arise. 

The CDER Exclusivity Board will likely have its hands full as companies continue to seek FDA guidance and determinations on exclusvity issues arising under the 1984 Hatch-Waxman Amendments, as well as under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).  Indeed, the BPCIA raises a whole host of new exclusivity issues for FDA to resolve.  Moreover, the Hatch-Waxman Amendments continue to evolve with amendments such as Section 4 of the QI Program Supplemental Funding Act of 2008 and the Generating Antibiotic Incentives Now Act (“GAIN Act”).  Future amendments to the Hatch-Waxman exclusivity provisions are also possible, such as the Life-Threatening Diseases Compassion through Combination Therapy Act of 2012 (H.R. 6502) (see our previous post here), which appears to be modeled after the GAIN Act.

Companies with questions regarding exclusivity matters may submit their queries by email to the CDER Exclusivity Board at CDERExclusivityBoard@fda.hhs.gov.