Nov. 15, 2012 12:48 PM ET
WASHINGTON (AP) — The top lobbyist representing compounding pharmacies says Congress does not need to draft new laws to oversee his industry, as lawmakers seek accountability for a deadly meningitis outbreak tied to contaminated medications.
In testimony Thursday before the Senate, the head of the International Academy of Compounding Pharmacists condemned the conduct of the pharmacy at the center of the outbreak, but said the company was operating as a rogue drug manufacturer and should have been shut down years ago by state or federal regulators.
More than 460 people have been sickened by contaminated steroid shots distributed by New England Compounding Center, and more than 32 deaths have been reported. The Senate hearing is meeting one day after a similar hearing in the House to scrutinize the oversight of compounding pharmacies, which currently operate in a legal gray area between state and federal regulation.
Compounding pharmacies, which mix customized medications based on prescriptions, are traditionally overseen by state pharmacy boards. But in recent years larger compounders like the NECC have emerged, mass-producing thousands of vials of drugs that can be shipped nationwide.
That trend has prompted calls for tighter oversight of compounders.
"We do not know where or how much large-scale drug compounding is being conducted, or if these companies are compounding drugs in accordance with best practice standards," said Sen. Tom Harkin, D-Iowa, who chairs the Senate health committee. "This is a problem and indicates to me the need for better federal regulation in this area."
But the compounding industry's trade group states that current state laws, if enforced, would have prevented the current outbreak. The compounding academy's CEO, David Miller, told lawmakers that the Framingham, Mass.-based pharmacy was shipping medication without first receiving prescriptions from doctors, a violation of its pharmacy license.
"The operations of NECC were clearly outside of the scope of the state's licensure requirements and their license should have been pulled long ago," stated Miller in prepared testimony.
The International Academy of Compounding Pharmacists has spent more than $1 million lobbying Congress in the past decade and has a track record of defeating measures opposed by the industry.
In 2007, Senators including Pat Roberts, R-Kan., and Ted Kennedy, D-Mass, introduced a bill to give the FDA more power to inspect compounders, set standards for sterile drugs and limit interstate sale of medications.
Roberts recalled Thursday that the bill was defeated after lawmakers were inundated by protests from the compounding industry.
Continue reading here
No comments:
Post a Comment