Opinion: The cost of doing nothing: Congress is missing a rare opportunity to improve FDA policies and help people with deadly illnesses

A "clean" user fee reauthorization package wastes a chance to enact patient-centered policies and regulations that would greatly improve research and reduce barriers for access to medical innovations.

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.

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