What is one of the primary functions of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA)?

The primary function of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is to collect user fees from industry to fund FDA review processes. This act significantly reauthorized and amended the Prescription Drug User Fee Act (PDUFA) and established fees that pharmaceutical and biotechnology companies must pay when submitting applications for new drugs and biologics. The revenue generated from these fees allows the FDA to hire more staff and invest in resources, ultimately speeding up the review and approval processes for new treatments and medical innovations.

This focus on user fees is particularly critical because it creates a financial mechanism that supports the FDA in fulfilling its mission to protect public health while remaining responsive to the demands of the industry and the needs of patients. The inclusion of user fees has enabled the FDA to improve efficiency in its operations and facilitate quicker access to medications.

Other options do not correctly represent the primary functions of FDASIA. Authorizing the marketing of new cosmetic products is not a primary focus of the act; rather, it concentrates on drugs and medical devices. Implementing mandatory labeling for nutritional supplements is related to other regulations but not specifically addressed in FDASIA. Enhancing the FDA's research capabilities is important, yet the act's distinct impact is primarily seen