GAO to FDA: Publish plans to issue or revise guidance on complex generic drugs

FDA said it will announce plans to issue or revise guidance for complex generic drugs after the U.S. Government Accountability Office (GAO) on Tuesday recommended the agency do so. The GAO report comes as FDA has sought to improve the way it reviews and approves these complex generic drugs.

FDA said it will announce plans to issue or revise guidance for complex generic drugs after the U.S. Government Accountability Office (GAO) on Tuesday recommended the agency do so. The GAO report comes as FDA has sought to improve the way it reviews and approves these complex generic drugs. The report noted some companies have criticized FDA's progress in bringing generic versions of these complex drugs to market. "While some stakeholders cited product-specific guidance as helpful, representatives of four brand sponsors said the guidance does not adequately address the scientific complexities of NBCDs [nonbiological complex drugs]," GAO said. "Further, guidance for some NBCDs was revised numerous times without any advance notification to industry, according to representatives of generic drug sponsors." GAO found that FDA approved generic versions of five of 28 drugs identified as complex generics prior to fiscal year 2017 and considered a range of data when assessing equivalence to the relevant brand-name drug. FDA noted it is undertaking an economic analysis to evaluate the impact of its Drug Competition Action plan. "Looking forward, we’re working to develop additional guidance for industry with the aim of clarifying 'sameness' requirements for ANDAs [abbreviated new drug applications]," FDA Commissioner Scott Gottlieb said in a statement. "We believe that guidance in this area may be particularly helpful for complex generics; including specific guidance on drug-device combination products."