President Trump signed the FDA Reauthorization Act of 2017 (FDARA), a bill that continues the U.S. Food and Drug Administration’s (FDA) authority to collect user fees from manufacturers of drugs and medical devices to fund the agency’s services. The HR 2430 bill, which passed through Congress with bipartisan support, includes the Prescription Drug User Fee Act, the Medical Device User Fee Amendments, the Generic Drug User Fee Amendments, and the Biosimilar User Fee Act.
The fees collected through the programs comprise $2 billion of the FDA’s $5 billion budget. The fees will be collected for the next five years and will expire in fiscal year 2022.
“The FDARA builds upon the goals outlined in previous user fee agreements and in the 21st Century Cures Act and will help us continue the essential work we are doing in many of our priority areas,” the directors of the FDA’s three medical product centers wrote in a statement announcing the decision. “The new law provides critical support for important FDA activities related to medical product regulation,” they added, including:
- allowing more flexibility to inspect medical devices based on risk
- facilitating the development of drugs and biologics for rare diseases
- streamlining combination product review to enhance coordination and transparency between the FDA and industry
“The FDA Reauthorization Act of 2017 [ensures] that safe and effective, life-saving treatments will continue to reach American patients, from innovative new drugs, to generic drugs, biosimilars, and medical devices,” Tom Price, MD, secretary of the Department of Health and Human Services (HHS), said in a statement. “The law will support our team at FDA as they carry out the HHS mission to enhance and protect the health and well-being of the American people and continue to advance medical breakthroughs.”
Source: FDA Voice blog, August 21, 2017.