Bipartisan FDA Reauthorization Bill Passes Senate Committee

The Senate Committee on Health, Education, Labor and Pensions has passed a bipartisan FDA reauthorization bill, which includes several provisions aimed at improving drug safety, bringing breakthrough treatments to patients more quickly, advancing medical device innovations and preventing critical drug shortages.


Specifically, the reauthorization bill includes provisions that would:

•    Enhance the ability of the FDA and increases oversight of the pharmaceutical industry to ensure U.S. prescription and over-the-counter drugs are both safe and effective
•    Expedite FDA approval and provide more flexibility for breakthrough drugs or treatments that show dramatic responses early in development, while still ensuring drug safety and efficacy
•    Reduce regulatory burdens that unnecessarily delay new medical devices from reaching the market, such as delays in the 510(k) process, and give the FDA tools to improve oversight and tracking of medical devices after they are approved
•    Spur development of new drugs to treat increasing cases of bacterial infections resistant to conventional antibiotics

The bill now faces a full Senate vote.

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