Published November 15, 2012
The top lobbyist representing compounding pharmacies will tell members of Congress that stricter federal oversight is unnecessary to oversee his industry, despite a deadly meningitis outbreak tied to contaminated medications.
Testimony released ahead of a Senate hearing Thursday shows that the head of the International Academy of Compounding Pharmacists will tell lawmakers that current regulations are adequate to police specialty pharmacies.
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. "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, will tell 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," Miller states 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.
"What we needed were more answers, what we got was pushback," Roberts said.