The U.S. Senate is slowly but surely making its way toward a vote on the latest iteration of the FDA’s user fee program, but a bevy of Republican amendments threatens to stand in the way.
As of today, there were nearly 40 total proposed amendments, including a withdrawn measure that aimed to repeal an unrelated 2.3% medical device sales tax contained in the Affordable Care Act.
"The disputes now are with the Republicans on a Republican amendment," Senate Majority Leader Harry Reid (D-Nev.) said on the Senate floor today. "On this side, we’ve cleared everything."
One such amendment was a short-lived measure by Sen. Orrin Hatch (R-Utah) to tie the user fee bill to his efforts to repeal the medical device tax. Hatch agreed on Monday to withdraw that effort in order to avoid derailing the FDA user fee discussion.
On Tuesday Sen. Scott Brown (R-Mass.) mentioned the device tax again in Senate user fee hearings, saying he was "disappointed the Senate has not yet taken time to address a key area of concern related to this bill; that is, the new medical device excise tax."
Brown did agree, however, that the user fee bill "needs to be passed as quickly as possible to guarantee regulatory certainty at the FDA for the industry and its stakeholders."
GOP Senators also took aim at a $20 million contract the Dept. of Health & Human Services signed with a public relations firm in the interest of promoting healthy living, disease prevention and how to take advantage of benefits provided by the Affordable Care Act, a campaign mandated within the health law.
"At a time of trillion-dollar deficits, the Dept. of Health & Human Services announced that it would go forward with a provision in the Affordable Care Act that apparently allows the department to spend $20 million of taxpayer money to launch a P.R. campaign to convince Americans that they should like the Affordable Care Act better than they apparently do," Sen. Roy Blunt (R-Miss.) said during the hearing. He proceeded to spend the next several minutes detailing shortcomings of and public opposition to the health care law.
"We’re close to a way to move forward on this bill," Reid said in his closing remarks."I hope we can get this worked out."
Reid has launched several failed motions to move forward with a vote on the use fee reauthorization bill, including an attempt, and the Senator warned that continued stagnation might lead him to file cloture or to move on to other legislations. The Senate discussed the measure again this morning, mostly without quorum, moving to pick up the hearing again at 2:30 p.m.
"We’re nearing a time where we can’t prolong this anymore," Reid said. "The information that we have in this bill – everything we need – expires at the end of this month."