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Pharmaceuticals / Regulatory Affairs

Senate Committee Advances FDA User Fee Reauthorization

May 19, 2017
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The Senate HELP Committee advanced to the full Senate a bill that would reauthorize FDA user fees through 2022. The vote was 21-2.

Sens. Bernie Sanders (I-Vt.) and Rand Paul (R-Ky.) voted against the measure.

The bill primarily would update and reauthorize current user fee agreements, which account for more than one quarter of the FDA’s annual budget, through fiscal 2022. PDUFA, GDUFA and BsUFA are expected to take in $1.42 billion in fiscal 2018, up from the $1 billion set for fiscal 2017.

A 20-item package of changes sponsored by committee chairman Sen. Lamar Alexander (R-Tenn.), added by voice vote, would call on the FDA to require drugmakers to include information about the risk of opioid addiction in their communications to healthcare providers and prescribers.

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