The Senate is poised to approve the measure to broaden the U.S. Food and Drug Administration’s oversight of compounding pharmacies. Ninety-nine senators have agreed to pass the legislation that the House passed without a roll call vote, Democratic and Republican lawmakers said.
Republican Senator David Vitter of Louisiana wants the vote on compounding pharmacies coupled with consideration of his proposal to deny lawmakers and their staffs employer contributions when they buy medical insurance on the exchanges set up under the new health-care law. As a result, senators may have to spend a week on work that could be done in minutes.
The bill, H.R. 3204, was written in response to a lethal outbreak of fungal meningitis among users of an injectable pain-killing steroid last year. The deaths and hundreds of infections forced the closing of New England Compounding Pharmacy Inc. in the Boston suburb of Framingham.
“We’ve cleared it with everyone but Mr. Vitter,” said Senator Tom Harkin, a sponsor of the companion Senate measure and chairman of the chamber’s Health, Education, Labor, and Pensions Committee.
During the negotiations, Vitter refused Majority Leader Harry Reid’s offer for a vote on his amendment provided he promise not to try to attach the proposal to other bills, Harkin said. Reid is a Democrat from Nevada.
“We just don’t want this to keep bubbling up every darn time in the future,” said Harkin, an Iowa Democrat. “You get one vote, what more could you ask for? He wouldn’t agree to that.”
Vitter is asking for floor time to debate and vote on an amendment that would strip lawmakers and their staffs of the employer contributions to their new health-insurance plans. Under the health-care law, members of Congress and their staff must drop their current plans with the Federal Employees Health Benefits Program and can buy policies offered in the new health-care exchanges. The Office of Personnel Management ruled that they could still keep the subsidies they had under the old system.
Clarify Authority
Vitter also has proposed ending the employer-paid portion of health premiums for the president, vice president and political appointees in the executive branch, who would have to obtain insurance from the exchanges instead of the program for federal employees.
Lindsay Bembenek, a spokeswoman for Vitter, said she had no immediate comment.
The compounding pharmacy legislation was drafted in response to calls by the FDA to clarify its authority after the agency was criticized for not acting quickly enough to close New England Compounding Pharmacy.
The company was identified as the source of an outbreak of fungal meningitis that killed more than 64 people last year. FDA officials cited conflicting legal decisions to explain the uncertainty about its authority to act sooner.
Republican Senator Lamar Alexander of Tennessee, where the Center for Disease Control linked at least 16 deaths to the fungal meningitis outbreak, said he hopes Vitter will accept Reid’s offer for a single vote on his amendment.
‘Another Tragedy’
“The FDA administrator has told us if we don’t act there will be another tragedy like the one that killed more than 50 people and made people sick,” Alexander said in an interview.
At a Bloomberg Government conference yesterday, FDA Commissioner Margaret Hamburg called the bill “a step in the right direction,” adding, “I don’t think it’s going to be as comprehensive as we had hoped.”
In congressional testimony earlier this year, Hamburg blamed a patchwork of state regulations over compounding pharmacies that restrained action by the FDA.
The legislation would would bar some kinds of drug compounding, a provision that may boost sales of medications that now face competition from compounded versions of other drugs, according to Brian Rye, a Bloomberg Government analyst.
For example, drugs to treat macular-degeneration such as Roche Holding AG (ROG)’s Lucentis and Regeneron Pharmaceutical Inc. (REGN:US)’s Eylea have faced competition from compounded versions of the cancer medication Avastin, according to Rye’s Oct. 2 analysis.
The last time Reid was in this position -- facing a demand from Vitter and other Republicans that time be spent on off-topic amendments -- the Nevada Democrat pulled bipartisan energy-efficiency legislation, S. 1392, from the floor.
The No. 2 Senate Democrat, Richard Durbin of Illinois, said the majority party’s leadership is serious about wanting Vitter to promise no reruns of his Obamacare amendment after it gets an up-or-down vote on the pharmaceutical bill.
“There reaches a point there where this is not a productive exercise but simply political harassment,” Durbin told reporters.
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