The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has responded to a US Government Accountability Office (GAO) report, regarding the FDA’s development of a better approach for the review and approval process for complex generic-drugs.

The GAO report, Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs, contained a single recommendation for the FDA: that the agency publicly announce its plans to issue or revise guidance for complex generic drugs.  

“We agree with GAO’s recommendation, and the FDA is actively working to accomplish this goal through new policies that are already underway,” Gottlieb said in a January 16, 2018 statement. “One of the first actions I took when I arrived at the FDA was announcing our Drug Competition Action Plan. This comprehensive plan was aimed at promoting competition and access, especially when it came to the development of generic drugs in pharmaceutical categories that lacked competition.”

The FDA says complex drugs are, by nature, harder to “genericize” under the FDA’s traditional approaches. As a consequence, these drugs can face less competition. The FDA says it is undertaking an economic analysis to evaluate the impacts of its policies and to guide further policymaking.

“Although we don’t formally recognize “nonbiological complex drugs” described in today’s GAO report as a separate class of drug products, we do recognize that the category of “complex generics” —the term that we typically use to describe this group of drug products—presents certain challenging scientific and policy issues,” Gottlieb said. “These challenges warrant specialized consideration by the agency. That’s why we’re looking for ways to maximize scientific and regulatory clarity with respect to complex generics.” 

For example, he said, to assist the generic-drug industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support abbreviated new drug application (ANDA) approval, the FDA publishes product-specific guidances describing the agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.

As part of the recent reauthorization of the Generic Drug User Fee Amendments in 2017 (GDUFA II), the FDA says it will focus resources specifically intended to aid generic drug developers of complex products. This includes its efforts as part of the pre-ANDA program, through which specialized advice can be provided on the generic drug development pathway. It also includes development of new product-specific guidance for complex generics. As part of GDUFA II, the FDA says it committed to issuing guidance for a complex product as soon as scientific recommendations are identified. 

Additional actions that the FDA is taking under the pre-ANDA program include regulatory science research that prioritizes new and more efficient methods to demonstrate equivalence of complex generics and making available face-to-face meetings with industry to clarify regulatory expectations early in the development of complex generics.

Looking forward, the FDA says it is working to develop additional guidance for industry with the aim of clarifying “sameness” requirements for ANDAs. “We believe that guidance in this area may be particularly helpful for complex generics; including specific guidance on drug-device combination products,” Gottlieb said.

Source: FDA, GAO report