The U. S. Food and Drug Administration (FDA) will likely undergo many changes in 2017 during the Trump Administration. Although Dr. Robert M. Califf has expressed a desire to remain as Commissioner, a new Commissioner will likely be appointed. Structurally, the FDA must establish at least one disease-focused intercenter institute in 2017 due to the recent passage of the 21st Century Cures legislation. FDA will continue to define the scope of “real world evidence” and establish acceptable uses to support both pre- and post-market evidentiary burdens. Numerous guidance documents are expected to be finalized—such as updates to novel clinical trial design, clarification on the Clinical Laboratory Improvement Amendments (CLIA) waiver policy, and collection and use of patient experience data in drug development.
2017 also marks the year of all of the User Fee Acts (UFAs) reauthorizations. The UFAs are statutory authorizations for FDA to collect user fees in exchange for establishment of performance measures on review and approval timeframes, which have historically also included numerous “modernizations” of FDA’s regulatory framework. The intense political negotiations between industry and FDA often seen during UFA re-negotiations may be tempered in this 2017 cycle, however, due to the need to implement the new provisions in the 21st Century Cures Act.
