WASHINGTON -- Legislation to broaden federal regulation of compounding pharmacies like the one linked to last year's meningitis deaths cleared a procedural hurdle in the Senate yesterday and could be on the desk of President Barack Obama within days.
The Senate voted 97-1 to advance H.R. 3204, removing an obstacle to eventual passage of the measure that would subject large compounding pharmacies to Food and Drug Administration oversight. The House has already passed the bill.
"This legislation is truly a matter of life and death," Majority Leader Harry Reid (D-Nev.) said on the Senate floor.
The measure would bar large compounding pharmacies from copying drugs approved by the FDA and marketed by other pharmaceutical companies. It would establish an electronic "track and trace" system to protect the safety of the nation's pharmaceutical supply chain.
The 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, Mass., to close.
The Senate vote removed a roadblock to passage posed by an objection from Sen. David Vitter (R-La.), who tried to force a vote on an amendment related to the 2010 health care law. -- Bloomberg News