Burgess and Green Highlight GAO Recommendations for Nonbiological Complex Drugs

Bipartisan Energy and Commerce Committee leaders today commented on a new report issued today by the Government Accountability Office (GAO). The report makes the case that the U.S. Food and Drug Administration (FDA) should update the public of its plans to issue guidance for nonbiological complex drugs. The Department of Health and Human Services (HHS) agreed with GAO's recommendations.

"We are encouraged by GAO's observations that FDA has taken steps to address the unique challenges of approving generic versions of nonbiologic complex drugs. Reauthorizing the Generic Drug User Fee Agreement last summer was another positive step that will help in this goal," said Health Subcommittee Chairman Michael C. Burgess, M.D. (R-TX) and Ranking Member Gene Green (D-TX). "We hope moving forward that FDA will continue to offer the generic industry additional guidance on complex products, and will begin to consistently share information about its plans to issue and revise guidance with the public. GAO's recommendations deserve thoughtful consideration—a transparent and consistent regulatory environment is crucial to ensure patients will have access to a competitive market of safe and effective products."

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