The GAO called on the FDA to make its plans for publishing and revising guidance for nonbiological complex drugs (NBCDs) public, noting that sudden guidance changes cause a major expense for generics developers and can delay or prevent market entry of products.
The GAO researchers analyzed the process by which the FDA reviews generics for NBCDs and reported that demonstrating equivalence is a major stumbling block for NBCD development.
Stakeholders disagreed on the effectiveness of the steps the FDA has taken to reduce the challenges. Some said product-specific guidances have been helpful, but several brand-name sponsors said the guidances did not adequately capture the complexity of NBCDs, and generic stakeholders said that such guidance was often revised without advance notice to industry. This short notice can delay market entry or prevent it entirely, according to the report.