GAO to FDA: Release new or revised guidance on complex generics; FDA says it's on it

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GAO called on the FDA to release or revise guidelines on complex generic drugs. The FDA said it's working on it.

In a 50-page report released Tuesday, the Government Accountability Office said the FDA should release plans to issue or revise guidance for complex generic drugs. In response, the FDA said they are working on new changes.

The GAO’s report landed just as the FDA has been working to improve its process for reviewing and approving complex generic drugs that can involve complex formulation, active ingredient, route of delivery, dosage form or be used in combination with a device.

However, the oversight agency noted that the FDA has been criticized by some companies for its timetable in getting those new drugs to market.

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"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),” the GAO said in the report. "Further, guidance for some NBCDs was revised numerous times without any advance notification to industry, according to representatives of generic drug sponsors."

The agency also noted that the FDA, stakeholders and the literature it reviewed said there are problems establishing that the brand and generic active ingredients are equivalent if the drug’s structure and other properties cannot be fully characterized.

Responding to the GAO report, the FDA said that since 2007 it has published 1,541 product-specific guidances for generic drugs. The regulatory agency said it also has embarked on developing 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."