Senate panel adds safety measures to FDA user fee act

April 25, 2012 by Brad Perriello

The U.S. Senate’s Health, Education, Labor & Pensions Committee passes the “Food & Drug Administration Safety and Innovation Act,” but fails to include provisions consumer advocates insist are necessary to protect patients from unsafe medical devices.

A key U.S. Senate panel today approved a bill designed to tighten safety standards at the FDA’s medical device arm, but the committee’s markups to the measure failed to win support from consumer advocates.

The Senate’s Health, Education, Labor and Pensions Committee voted to approve the “Food & Drug Administration Safety and Innovation Act,” which would beef up the FDA’s safety regulations, allowing the federal watchdog agency to conduct safety studies of devices after they’ve been approved and to grant conditional approvals contingent on further trials. The only “nay” in the voice vote was Sen. Bernie Sanders (I-Vt.).


Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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