GAO Report Calls for FDA to Publicly Announce Guidance on Nonbiological Complex Drugs

Published on: 

The US Government Accountability Office released a report stating that FDA should make its plans to release guidance regarding nonbiological complex drugs public.

On Jan. 16, 2017, the US Government Accountability Office (GAO) published a report regarding FDA’s review and approval of nonbiological complex drugs (NBCDs). The report recommends that FDA make public its plans to issue and revise guidance on these products.

GAO states in the report that “FDA issues new guidance documents and revises existing ones unexpectedly, which can create setbacks for generic drug companies.” According to the report, some sponsors stated that product-specific guidance that provide FDA recommendations on how to demonstrate equivalence for certain products do not adequately address the scientific complexities of NBCDs. The numerous revisions by FDA, often made without advance notice, further complicated the issue. FDA’s annual list of guidance documents does not include product-specific guidance, according to GAO.

“The lack of advance communication on guidance issuance and subsequent revisions can create setbacks for generic drug sponsors. For example, according to such sponsors, it may take considerable time, effort, and other resources for them to update their applications to market a generic drug in response to unexpected changes in guidance. This could delay or prevent the entry of some generics to the market,” GAO stated in the report.

FDA has responded by saying the agency is working to resolve these issues through the Drug Competition Action Plan. In a statement, FDA Commissioner Scott Gottlieb said, “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. 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. 


The agency is planning to focus resources to aid generic-drug companies developing complex products. Gottlieb also announced guidance documents published in 2017 and stated the agency is working to increase transparency regarding upcoming guidance documents on complex drugs.

“We believe that increased transparency on product-specific requirements gives manufacturers seeking to develop generic copies of complex drugs a better opportunity to efficiently allocate resources … Our aim is to make sure that our policies and regulations – and our scientific and clinical standards-keep pace with the nature of these complex products, as well as the challenges we face in protecting consumers and promoting drug competition and access when it comes to generic medicines,” Gottlieb stated.

Source: FDA