User Fee Amendments In Senate Filed, But Track-And-Trace Remains Off The Map
This article was originally published in The Pink Sheet Daily
System standards could be included in the manager’s amendment, which was not complete May 18. A cloture vote could come late May 21, which would delay the start of floor debate.
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The new bill includes a provision requiring FDA to consider foreign clinical trial data when making approval decisions and more patient participation in drug development meetings. A cloture vote could come as soon as May 17 with floor debate possibly beginning next week, Sen. Reid says.
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.
Sen. Leahy plans to introduce legislation to overturn the Supreme Court’s ruling in Pliva v. Mensing; the attorney who represented generic manufacturers in that case says the legislation is unlikely to pass.