CQ TODAY ONLINE NEWS
May 23, 2012 – 5:10 p.m.
Deal Sets Up User Fee Bill Passage
By Emily Ethridge, CQ Staff
The Senate is moving rapidly toward passage of a five-year user fee reauthorization for the Food and Drug Administration on Thursday, with strong bipartisan support expected.
Senators agreed Wednesday to limit themselves to 17 amendments, then proceeded to approve six of the least controversial proposals by unanimous consent before wrapping up for the day.
The amendment deal was a week in the making after Iowa Democrat
Reaching the final agreement involved cutting deals to separately consider measures to reauthorize the National Flood Insurance Program and to maintain the interest rate for federal student loans, two unrelated issues that lawmakers had nonetheless threatened to try to attach to the FDA user fee bill.
But the heart of the deal was the decision to limit amendments. The Senate is expected to begin votes on them at 2 p.m. Thursday, although Majority Leader
“We have tomorrow to finish this,” the Nevada Democrat said in his afternoon announcement of the deal. “There’s no reason that it should spill over until the next day.”
Although none of the amendments are expected to trip up final passage of the bill, every proposal that the Senate adopts will widen the differences between the measure and the House bill (
Both measures are five-year reauthorizations of the FDA’s ability to collect user fees from the drug and medical device industries to help fund the agency’s reviews of their products. The measures would also create two user fee programs for generic drugs and generic biologic drugs, and they contain language aimed at improving the safety of the drug supply chain. Both would permanently reauthorize programs aimed at encouraging manufacturers to develop drugs for pediatric patients and to conduct pediatric studies of their products.
Leaders in both chambers have set a goal of sending final legislation to President Obama’s desk by early this summer, and they have steered away provisions that could sink the bill.
To that end, at least one senator said he would not press for a vote on his amendment, even though it was included in Wednesday’s deal.
“At the end of the day, the reality is that this probably upsets the apple cart a little too much,” North Carolina Republican
Supermajority Votes Required
Of the remaining 10 amendments, four will require 60 votes for adoption under the agreement.
Deal Sets Up User Fee Bill Passage
One is a proposal by New Mexico Democrat
Bingaman’s amendment would allow companies that produce generic drugs to share some of the 180-day marketing exclusivity period given to the original generic patent holder if that holder enters into a delay deal.
Another amendment, from Arizona Republican
The pharmaceutical industry strongly opposes the idea, saying it could lead to an increase in counterfeit drugs. It successfully lobbied to keep a similar amendment from being added to the 2010 health care law (PL 111-148, PL 111-152). But senators from both parties, particularly those from border states, and advocates for patients support opening access to cheaper drugs. Harkin, who has supported similar proposals, is concerned that the McCain amendment would become a poison pill to the underlying bill.
Amendments from Alaska Republican
Sanders’ amendment would end a company’s exclusive marketing rights if it is found guilty of fraud, including adulteration or illegal marketing of a particular drug.
A few of the remaining amendments will likely lead to brief floor fights. One, from Majority Whip
“The dietary supplement industry hates my amendment like the devil hates holy water,” the Illinois Democrat said Wednesday.
A proposal from Kentucky Republican
Harkin said Paul’s amendment would threaten passage of the bill and “destroy” the 1994 law (PL 103-417) that allows the FDA to take regulatory action against dietary supplements that are unsafe, that make false or misleading claims, or are otherwise adulterated or misbranded.
“It would turn our current system of drug regulation on its head,” Harkin said on the floor Wednesday.
One of the amendments that did not make it into the agreement would have repealed the 2.3 percent excise tax on medical devices scheduled to take place in 2013 under the health care overhaul. Sponsor
As part of the deal to move forward on the FDA bill, Reid committed to bringing up a 60-day extension of the National Flood Insurance Program’s authorization this week and a five-year reauthorization during the next work period, which begins in June. The current stopgap authorization (PL 112-74) expires May 31.
Deal Sets Up User Fee Bill Passage
Following a vote on passage of the FDA bill, the Senate will vote on a Democratic proposal (
Niels Lesniewski and Elham Khatami contributed to this story.