FDA Reauthorization Act of 2017 (FDARA, P.L. 115-52)

Summary

Food and Drug Administration (FDA) review of medical products (human drugs and devices) is funded through a combination of annual discretionary appropriations from Congress (budget authority) and user fees collected from industry. The human medical product user fee programs require reauthorization every five years to continue uninterrupted. Prior to the passage of the Food and Drug Administration Reauthorization Act of 2017 (FDARA, P.L. 115-52), these programs were set to expire on September 30, 2017. The reauthorization legislation typically includes additional provisions related to FDA, since for many the bill is considered “must-pass” legislation in order to not interrupt FDA product review activities.

FDARA continues the five-year reauthorization cycle of the human medical product user fee programs; this reauthorization allows FDA to keep collecting user fees and using the revenue to support, among other things, the review of marketing applications for brand-name and generic drugs, biological and biosimilar products, and medical devices. In addition to titles that reauthorize the four user fee programs (drugs, devices, generic drugs, and biosimilars) through FY2022, FDARA includes titles that

modify the drug and device regulatory processes to encourage the development of drugs and devices for pediatric use;

amend the law regarding medical device, prescription drug, and generic drug regulation; and

make changes in several cross-cutting areas, such as annual reporting on inspection and analysis of use of funds.

The passage of the 21st Century Cures Act (P.L. 114-255) in December 2016 made numerous changes to the FDA approval processes for drugs, devices, and biologics, as well as other reforms to FDA; therefore, fewer non-user fee provisions were included in FDARA.

This report presents an overview of FDARA by title and section, providing a narrative context for each title, as well as a brief description of each section.