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From Health Law Daily, May 29, 2015

FDA’s approval of generic versions of Abilify® survives challenge

By Mary Damitio, J.D.

The FDA had the authority to allow manufacturers of generic versions of Abilify to carve out certain uses from the labeling in order to protect orphan drug exclusivity. Nothing in either the statutory language at issue in the Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. § 355a(o), or in the legislative history implied that the FDA did not have the authority to permit the carve-outs and as such, deference should be given to the agency’s expertise in applying the statute and its own regulations (Otsuka Pharmaceutical Co. v. Burwell, May 27, 2015, Hazel, G.).

Background. Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical Inc., known collectively as “Otsuka” are the New Drug Application (NDA) holder of the prescription drug Abilify. The FDA approved Abilify in November of 2002 for treatment of schizophrenia and it has been subsequently approved for treatment of schizophrenia in adolescents, manic and mixed episodes accompanying Bipolar I Disorder in adults and pediatrics, irritability accompanying autistic disorder for pediatric patients, and as a depression treatment add-on for adults. In 2006, Otsuka’s Supplemental New Drug Application (sNDA) was granted orphan drug designation for Abilify for the treatment of Tourette’s Disorder in children and adolescents, which created a seven-year period of market exclusivity running from the date of approval.

FDA approval of generics. In April 2015, the FDA approved four generic versions of Abilify, or aripiprazole. The FDA subsequently sent a letter to Otsuka stating that it had determined that applicants seeking to market generic versions of Abilify could omit the Tourette’s Disorder indication from their labeling. Otsuka brought suit challenging the FDA’s approval and alleged that because the FDA recently approved the pediatric indication for Abilify, which is protected by orphan drug exclusivity, the FDA is prohibited from approving generic versions of Abilify until its orphan drug exclusivity expires in December 2021 because 21 U.S.C. § 355a(o) does not allow the type of pediatric information to be omitted from the generic version’s label. Otsuka sought to stay the FDA approval of the generic drug versions and to stop the FDA from making any further approvals until the end of the exclusivity period.

Deference to the FDA. The FDA’s determination was entitled to a heightened level of deference known as “Chevron deference” due to its expertise with regard to the complex regulatory scheme and the fact that the FDA’s determination was based on its established understanding of its “carve-out” authority and clear precedent on the issue. As a result, the court had to apply the Chevron two-step process to determine whether Congress has spoken on the issue and if the FDA’s decision was based upon a permissible interpretation of the FDC Act.

Congressional intent. Congress had not “spoken” on this issue because nothing in the text of 21 U.S.C. § 355a(o) prohibited the FDA from omitting information relating to pediatric orphan drug exclusivity from a generic’s drug label. Additionally, nothing in the legislative history indicated that that Congress intended that this section purposefully excluded orphan drug exclusivity.

FDA’s statutory construction. The FDA’s determination, which was afforded a highly deferential standard of review, was based upon a permissible construction of the Food, Drug, and Cosmetic Act (FDC Act). Under the Act, the FDA has broad authority to approve the carving out of uses on labels to protect orphan drug exclusivity (e.g.: 21 U.S.C. § 355(j)(2)(A)(v)). Additionally, its own regulations give the FDA authority to carve out uses from labeling (21 C.F.R. Sec. 314.94(a)(8)(iv). Furthermore, the Orphan Drug Act also supports the FDA’s determination because the language of 21 U.S.C. § 360cc(a) is clearly disease-specific, and not drug-specific. Therefore, the Act protects specific uses rather than to drugs for all uses. Additionally, the FDA has consistently applied the carve-out provisions when approving drug products during seven-year orphan drug exclusivity periods. As a result, the FDA’s motion for summary judgment was granted.

The case is No. GJH-15-852.

Attorneys: Maggie Grace (Venable LLP) for Otsuka Pharmaceutical Co., Ltd., Otsuka America Pharmaceutical, Inc. and Otsuka Pharmaceutical Development & Commercialization, Inc. Roger Joseph Gural, U.S. Dept. of Justice, for U.S. Food and Drug Administration.

Companies: Otsuka America Pharmaceutical, Inc.; Otsuka Pharmaceutical Development and Commercialization, Inc.; Otsuka America Pharmaceutical Inc.; Apotex Inc., Apotex Corp., Teva Pharmaceuticals USA, Inc.; Alembic Pharmaceuticals Ltd.; Alembic Ltd.; Alembic Global Holdings S.A.; Alembic Pharmaceuticals, Inc.; Zydus Pharmaceuticals (USA) Inc.; Torrent Pharma Inc.; Torrent Pharmaceuticals Ltd.; Sandoz, Inc.

MainStory: TopStory LabelingNews DrugBiologicNews FDCActNews GenericDrugNews MarylandNews

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