House Passes Bipartisan Measure To Reauthorize FDA User-Fee Programs
On Wednesday, the House on Wednesday approved legislation (S 3187) that would reauthorize and modify FDA's prescription drug and medical device user-fee programs, after House and Senate leaders reached a bipartisan deal on the bill earlier this week, the Wall Street Journal reports (Burton, Wall Street Journal, 6/20).
About the Legislation
Republican and Democratic 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 (California Healthline, 5/31).
The agreement, which was added as an amendment to the Senate bill, contains elements from both bills (Ethridge, CQ Today, 6/18).
The Senate is expected to approve the bill next week, in time for it to reach President Obama's desk by the July 4 congressional recess (Wall Street Journal, 6/20).
Lawmakers Praise Bipartisan Effort
Lawmakers from both parties praised the bipartisan effort to approve the bill, The Hill's "Floor Action Blog" reports.
House Energy and Commerce Committee Chair Fred Upton (R-Mich.) said the legislation "is a reflection of the hard work put in by both members and staff, and of everyone's willingness to put partisanship aside" (Kasperowicz, "Floor Action Blog," The Hill, 6/20).
A Senate Democratic staffer said lawmakers "really wanted to get this done before the politics take over" after the Supreme Court releases its ruling on the constitutionality of the federal health reform law (Norman, Politico, 6/20).
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