Congress Shouldn’t Pass FDA Reform Bills Without Addressing Patient Safety and Drug Prices

“Congress Shouldn’t Pass FDA Reform Bills Without Addressing Patient Safety and Drug Prices,” Diana Zuckerman, The Health Care Blog.

A major proposed law that alters the way the Food and Drug Administration (FDA) approves drugs and medical devices has been wending its way through Congress since 2014. The Cures bill and Senate legislation seek to speed-up drug and device approval by weakening many of FDA’s safety and effectiveness standards, without strengthening post-market tracking and evaluation of products. Momentum is building on Capitol Hill to pass the legislation in the current “lame-duck” session of Congress.

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Update: The 21st Century Cures Act passed in the House on November 30, the Senate on December 6, and was signed by President Obama on December 13.

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