Senate Paves Way for Final Floor Vote on FDA User-Fee Legislation
On Monday, the Senate cleared a procedural hurdle that paves the way for a final vote today on House-approved compromise legislation (S 3187) that would reauthorize and modify FDA's prescription drug and medical device user-fee programs, Modern Healthcare reports (Daly, Modern Healthcare, 6/25).
Senators voted 89-3 to end debate on a motion to concur, easily surpassing a 60-vote minimum required for cloture (Khatami, CQ Today, 6/25).
Sens. Richard Burr (R-N.C.), Rand Paul (R-Ky.) and Bernard Sanders (I-Vt.) cast the dissenting votes (Strauss, "Floor Action Blog," The Hill, 6/25).
About the Legislation
House and Senate leaders reached a bipartisan deal on the measure last week.
The leaders and their staff had met in a conference committee to reconcile the differences between the House (HR 5651) and Senate (S 3187) versions.
Both measures would have reauthorized the user-fee programs -- which are scheduled to expire at the end of September -- for five years. They included provisions to address drug shortages, improve drug supply chain safety and establish new user-fee programs for generic drugs and generic biologics, or biosimilar drugs.
The agreement, which was added as an amendment to the Senate bill, contains elements from both bills (California Healthline, 6/21).
The Senate is expected to approve the bill and send it to President Obama by Tuesday (Norman, Politico, 6/25).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.