According to a recent decision by a Maryland federal court, the Food and Drug Administration (FDA) acted permissibly when it approved generic versions of Otsuka Pharmaceutical Co. Ltd.'s (Otsuka) product Abilify even though Otsuka retained marketing exclusivity for the drug. This ruling was the most recent in a series of decisions regarding the FDA's decision to approve aripiprazole, the generic version of Abilify. In a decision last month, the court rejected Otsuka's bid to prevent the sale of a generic version of the antipsychotic, which is currently one of the best-selling drugs on the market.
These rulings have been seen as a success for the FDA as the court held that the federal agency was correct in its interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) in a manner to allow the sale of generic versions of Abilify with labeling that omits Otsuka's exclusivity protected indication for Tourette's syndrome. The suit revolves around FDCA provision 21 U.S.C. §355a(o), which states that proposed generics "shall not be considered ineligible for approval...on the basis that the labeling of the drug omits a pediatric indication or any other aspect of labeling pertaining to pediatric use when the omitted indication or other aspect is protected by patent or by exclusivity..."
While Otsuka argued that this provision only allows the FDA to omit pediatric information from generic drug labels in these two instances, the FDA contended that this provision prevents them from denying approvals based on these omissions, but does not prevent them from allowing omissions in other instances. The court responded to this argument by holding that "Otsuka cannot...turn a provision limiting FDA's disapproval authority into a provision limiting its approval authority." In the order granting summary judgment, the court held that "...the FDCA, its legislative history, the case law, and the FDA's regulations all support the FDA's construction of the statute..."
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