Tighter Compounding Pharmacy Oversight Advances in SenateJames Rowley
Legislation to broaden federal regulation of compounding pharmacies like the one linked to last year’s meningitis deaths may reach President Barack Obama’s desk in days after clearing a procedural hurdle in the U.S. Senate.
The Senate may vote on passage as early as today, following yesterday’s 97-1 vote to advance the measure that would subject large compounding pharmacies to Food and Drug Administration oversight. The House has already passed the bill, H.R. 3204.
“This legislation is truly a matter of life and death,” Majority Leader Harry Reid, a Nevada Democrat, said on the Senate floor.
The bill would bar large compounding pharmacies from copying drugs approved by the FDA and marketed by other pharmaceutical companies.
That provision may help boost sales of medicines made by Regeneron Pharmaceuticals Inc. and Roche Holding AG, whose macular degeneration drugs face competition from products made by compounders, according to an Oct. 2 report by Bloomberg Government analyst Brian Rye.
In addition, the bill would establish an electronic “track and trace” system to protect the safety of the nation’s pharmaceutical supply chain.
The compounding-pharmacy language was drafted in response to a fatal outbreak of fungal meningitis that was traced to contaminated vials of an injectable painkilling steroid. The outbreak, which killed 64 people and infected more than 750 in 20 states, forced the manufacturer, New England Compounding Pharmacy Inc. in Framingham, Massachusetts, to close.
The FDA was criticized for not acting quickly enough to shut the company; once the outbreak subsided, the agency asked Congress to clarify its authority over compounding pharmacies.
The legislation will put larger companies, known as “outsourcing facilities,” under FDA oversight if they agree to be inspected. Supporters said they were counting on market forces to prod these suppliers to submit to FDA regulation.
Small compounders that mix ingredients for individual prescriptions will continue to be regulated by states.
At a Nov. 5 Bloomberg Government conference, 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.”
Yesterday’s Senate vote removed a roadblock posed by an objection from Senator David Vitter, who tried to force consideration of an amendment tied to the 2010 U.S. Patient Protection and Affordable Care Act, known as Obamacare.
The Louisiana Republican, who was the only senator to oppose advancing the bill, is seeking to force lawmakers to disclose who on their staffs are listed as working in their “official office.” Under the law, as of Jan. 1, the only health insurance those employees can get through the government must be obtained on the newly created state insurance exchanges.
Congressional staff not listed as working in a member’s “official office” can keep getting insurance through the federal employees’ benefits program. The law failed to define “official office,” and an Obama administration ruling left that determination up to individual lawmakers.
Vitter had rejected an offer by Reid for a vote on his amendment if he promised not to try to attach the proposal to other legislation. Vitter has said he would offer it as an amendment when the Senate debates the $625 billion defense authorization bill, S. 1197, later this week.
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