• Office of Generic Drugs “Super Office” Becomes a Reality; New “Office of Generic Drug Policy” Will Handle Hatch-Waxman Issues
  • December 30, 2013 | Author: Kurt R. Karst
  • Law Firm: Hyman, Phelps & McNamara, P.C. - Washington Office
  • In a recent memorandum to Center for Drug Evaluation and Research (“CDER”) staff, CDER Director Janet Woodcock, M.D. announced that the Department of Health and Human Services approved the reorganization of FDA’s Office of Generic Drugs (“OGD”). The proposed elevation of OGD into a “super office” was announced in September 2012 (and was even the topic of legislation introduced in March 2012 as we previously reported), just months after the enactment of the Generic Drug User Fee Amendments (“GDUFA”). The reorganization of OGD is intended to, among other things, make it easier for the Office to meet “the evolving needs of generic drug review” and GDUFA performance goals. Another recent announcement that FDA and the European Medicines Agency are launching a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals may also go a long way to help FDA meet its GDUFA goal of achieving parity of inspections for foreign and domestic manufacturing facilities.

    The reorganization - actually, an almost total restructuring - of OGD as a result of GDUFA has been a hot topic of discussion and debate here on this blog and in the generic drug industry in general. At the Generic Pharmaceutical Association Fall Technical Conference, several presenters from OGD, including Acting OGD Director Kathleen “Cook” Uhl, M.D. and OGD Regulatory Counsel Keith Flanagan laid out in presentations the Office’s accomplishments and introduced the GDUFA Steering Committee - a committee composed of senior FDA personnel to oversee GDUFA implementation and to ensure alignment across CDER components.

    According to Dr. Woodcock, a new OGD-centric team has also been formed - the “OGD Transition Team” - to implement the new OGD super office and reporting structures. The new OGD structure will consist of four offices (with various divisions): (1) the Office of Research and Standards; (2) the Office of Bioequivalence ; (3) the Office of Regulatory Operations; and (4) the Office of Generic Drug Policy.

    This last office - the Office of Generic Drug Policy - includes the Division of Legal and Regulatory Support and the Division of Policy Development, and it really caught our attention. Why? Because, as we understand it, one of the major focuses of this office will be handling and resolving Hatch-Waxman disputes. Previously, disputes over issues like 180-day exclusivity eligibility and forfeiture were handled by a conglomeration of FDAers from various Agency components. Bringing together a team of attorneys and regulatory professionals - which likely means that FDA/OGD will be on a hiring spree to bring on board some bright young attorneys - should be a welcome move for the generic drug industry. Like the CDER Exclusivity Board, which focuses on 5-year new chemical entity exclusivity, 3-year new clinical trial exclusivity and exclusivity for biological products, but not on 180-day exclusivity (or orphan drug exclusivity), and that is intended to bring clarity and consistency to exclusivity decisions, a division or group within OGD to handle ANDA and 180-day exclusivity issues and disputes could bring greater clarity (and speed?) to FDA’s decisions and decision-making process. It may also mean a change in how FDA does business to address disputes, and could result in some innovative thinking on how to better inform the generic drug industry about 180-day exclusivity forfeitures or whether another applicant’s eligibility for exclusivity will block approval.