User Fee Legislation Revs Through Senate Mark-up, But House Bill Goes Back Into The Shop
Senate health committee defers action on several potentially contentious issues, with members hoping to resolve differences over FDA’s authorities on imports, shortages, foreign data and track-and-trace before the bill goes to the floor, possibly in May. Meanwhile, the House postpones its mark-up in an effort to craft a more bipartisan bill, and now will try to push the user fee package to the floor during an upcoming four-day marathon session.
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Legislative language would consider a drug adulterated if it does not have the necessary quality management systems in place as required in current Good Manufacturing Practices.
After about a week of debate, the Senate overwhelmingly passes its FDA user fee package, with only track and trace to be finalized. House members are scheduled to begin floor debate after Memorial Day in the hopes of sending the bill to President Obama before July 4.
Language in manager’s amendment is considered a placeholder, and a resolution could come when the Senate’s FDA user fee bill reaches the conference committee. But first, the bill needs to pass.