On June 8, the U.S. House of Representatives passed its comprehensive legislation to reauthorize the Food and Drug Administration (FDA) user fee agreements, including the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Act (MDUFA).
The Association for Clinical Oncology (ASCO) submitted comments earlier this year outlining ASCO’s policy priorities for inclusion in this legislative package. ASCO is pleased that several of the Association’s priorities were included in the final House-passed bill, including provisions to:
- Increase the diversity of clinical trials through improved clinical trial access and enrollment of diverse patient populations
- Strengthen the accelerated approval process by giving FDA additional authority to ensure products that receive accelerated approval are providing a clinical benefit to patients in a timely manner
- Expand the use of real-world evidence and real-world data to supplement clinical trial data and establish real-world effectiveness and toxicity
- Ensure the safety and efficacy of medical products by providing FDA with new tools and processes to allow the agency to better carry out reviews and inspections
- Bolster FDA’s oversight of drug manufactures to prevent drug shortages
- Helps preserve patient access to treatments for rare diseases and conditions by codifying the FDA’s longstanding interpretation of the Orphan Drug Act
Separately, on June 14, the Senate HELP Committee held a markup and advanced its version of the FDA reauthorization package legislation. ASCO submitted comments to the Committee urging them to include the above provisions in the Senate version of the legislation, as well as suggested a few changes to the provisions in the Senate package to strengthen the accelerated approval program and reform the regulatory framework for in vitro clinical tests. ASCO applauds the Senate HELP Committee for including a number of these proposed changes in the final bill text.
ASCO urges the relevant House and Senate committees to work together to reconcile the two packages and pass a bill that includes policies that ensure all patients have access to safe and effective therapies, including through clinical trials.
ASCO members should use the ACT Network to urge their Senators to swiftly pass FDA reauthorization legislation that includes ASCO’s priorities.
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