Senate Approves Legislation to Renew FDA User Fee Programs for Medical Devices and Prescription Drugs, Ensuring Access to Critical Funding to Support the Agency’s Regulatory Responsibilities for the Next Five Years

Last week, the bipartisan supported FDA Reauthorization Act (FDARA) of 2017 (H.R. 2430) passed the Senate by a vote of 94–1. The bill had already been approved by the House of Representatives by a voice vote on July 12.

As its name indicates, the FDARA would reauthorize the FDA user fee programs for medical devices, prescription drugs, biosimilars, and generic drugs. User fees are collected from companies that develop drugs and medical devices, and substantially contribute financial resources (approximately $1.4 billion annually) to the FDA’s budget for premarket review activities. H.R. 2430 also includes provisions to improve the FDA’s drug review process, including greater use of real-world evidence and enhancement of drug development tools, including biomarker development. The FDA’s review activities help promote rapid access to innovative therapies and technologies, resulting in improved healthcare results and lower prices for Americans.

H.R.2430 will extend the FDA’s five-year authorization to fiscal year 2022. The agency’s current authority expires at the end of September. Now that the bill has passed both houses of Congress, it has been sent to President Trump’s desk to be signed into law.