FDA Reauthorization Bill Clears Senate By 96-1 Vote
The Senate voted overwhelmingly Thursday afternoon to pass a bill to reauthorize the Food and Drug Administration’s user fee programs.
Politico: FDA User Fee Bill Passed By Senate
Previous user fee authorizations have been contentious affairs. But notwithstanding the election-year and health care politics that dominate Congress, the bill sailed through with hardly a complaint. In part, that’s because it’s the No. 1 priority for the pharmaceutical and medical device industries. And in part, it’s because legislators on both sides have had a lot of input for a long time (Norman, 5/24).
Reuters: U.S. Senate Passes Bipartisan FDA Funding Bill
The bill, which passed by a vote of 96 to 1, aims to speed approval of new drugs and devices and ensure food safety. It reauthorizes fees from companies like Johnson & Johnson, Medtronic Inc and Roche Holding AG that help speed FDA evaluation of new medical products prior to approval (Yukhananov, 5/24).
CQ HealthBeat: Senate Passes FDA User Fee Bill, Spurns Drug Importation Amendment
Senators gave strong bipartisan backing to a five-year reauthorization of the Food and Drug Administration’s user fee programs Thursday, after rejecting a contentious drug importation amendment that had support from members of both parties. The bill (S 3187), passed 96-1, would renew the FDA’s programs that help fund reviews of prescription drugs and medical devices. The measure also would create user fee programs for generic drugs and generic biologic drugs. Vermont Independent Bernard Sanders cast the lone vote against the bill (Khatami and Lesniewski, 5/24).
National Journal: Senate Votes to Approve FDA Bill 96-1
The bill authorizes $6.4 billion in fees from the medical device and pharmaceutical industry to the FDA, to help cover the cost of making sure new products are safe and effective. ... The House is expected to take up and easily pass its own version of the legislation next week (McCarthy, 5/24).
Associated Press: Senate Bill Aims To Increase Drug Import Safety
Under the Senate bill, approved 96-1, the Food and Drug Administration would have more flexibility to inspect manufacturing sites in China, India and other foreign countries. ... Other sections of the bill would increase fines for drug counterfeiting and require drugmakers to notify the government earlier of potential drug shortages. ... The legislation also renews user fee programs under which drugmakers pay the FDA to review new products (5/24).
The Hill: Senate Reaches Deal On FDA Bill Amendments
Under the agreement, the Senate will consider 17 amendments to the bill, the Food and Drug Administration Safety and Innovation Act (S. 3187), which reauthorizes a user-fee program for drug companies seeking FDA approval. The Senate will debate amendments until Thursday at 2 p.m. After votes on the amendments, the Senate will vote on the bill itself (Strauss, 5/23).
CQ HealthBeat: FDA Reauthorization Has Bipartisan Support; 17 Amendments In Question
After a day of delay, the Senate reached a deal to vote Thursday afternoon on 17 amendments, then on final passage of the bill to reauthorize the Food and Drug Administration’s user fee programs for five years. The FDA reauthorization bill has bipartisan support and is expected to pass. The only question is which amendments will be added to the measure. Some of the amendments may be adopted by voice vote, while others are much more controversial.“We have tomorrow to finish this. We should be able to do that,” Majority Leader Harry Reid, D-Nev., said on the floor Wednesday afternoon (Ethridge, 5/23).
Politico Pro: Senate FDA Bill Down To 17 Amendments
HELP Chairman Tom Harkin (D-Iowa) and ranking member Mike Enzi (R-Wyo.) parried offerings of various additions to their hard-negotiated bill and were expected to oppose the most controversial proposals, three lobbyists told POLITICO. Four amendments, in particular, are subject to the high bar of a 60-vote threshold, which cuts into their chances of success — but they're still expected to receive a vote when the Senate wraps up work on the bill Thursday (Norman, 5/24).