The Hill - Senate Health Panel Floats Proposal for Speedy Food and Drug Administration Approval of Life-Saving Drugs

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By Julian Pecquet

The Senate panel with jurisdiction over the Food and Drug Administration on Wednesday released a discussion draft of legislation aimed at accelerating patient access to innovative medical treatments for life-threatening diseases.

The Health, Education, Labor and Pensions Committee's bipartisan Drug Approval and Patient Access Plan would overhaul the FDA's Accelerated Approval pathways and create a new "breakthrough" designation to provide more flexibility and certainty for developers of new medicines intended to address serious or life-threatening diseases or conditions.

The draft includes legislation introduced last week by Sen. Michael Bennet (D-Colo.) that would expedite FDA approval and provide more flexibility when a drug or treatment shows dramatic responses early in development.

"We're seeing major breakthroughs in drugs and other treatments for debilitating and terminal diseases, but we're not always getting them to patients though the most efficient and safe pathways," Bennet said in a statement Wednesday. "This bipartisan plan is a good starting point to ensure patients have access to safe, innovative treatments as quickly as possible."

The proposal would become part of legislation to reauthorize user fee legislation, which expires Sept. 30.

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