Congress has taken the necessary step of including critical reauthorizations for the Prescription Drug User Fee Act in its continuing resolution that will avert a partial government shutdown. Successful reauthorization of the act, which sets the funding structure for the Food and Drug Administration, will ensure that it has the funds to fulfill its vital mission.
But by passing a “clean” reauthorization of PDUFA, Congress is missing a rare opportunity to improve public health policies that could greatly benefit people with cancer and others by expanding access to cutting-edge therapies through clinical trials and improving the FDA’s existing Accelerated Approval Program to ensure that drugs meet certain safety and efficacy standards.
During the previous several months, members of the Senate’s Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce, in consultation with leadership in both chambers, had been negotiating a number of policy “riders” that would attach new policies to the “must-pass” PDUFA that every five years puts in place a structure for the fees drug and device makers must pay to the FDA to review applications for marketing approval.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and networking platform access.
Already have an account? Log in
Already have an account? Log in
To submit a correction request, please visit our Contact Us page.
STAT encourages you to share your voice. We welcome your commentary, criticism, and expertise on our subscriber-only platform, STAT+ Connect