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.
"What we needed were more answers, what we got was pushback," Roberts said.
Senators also heard testimony from Food and Drug Administration Commissioner Margaret Hamburg, who recommended new legislation to give the FDA more direct oversight over compounding pharmacies. In her second congressional appearance this week, Hamburg described again the "crazy quilt" of conflicting laws and court rulings that she says limit the agency's ability to take action.
Hamburg suggested Congress mandate a two-tier system in which traditional compounding pharmacies continue to be regulated at the state level, but larger pharmacies would be subject to FDA oversight.
But some Senators expressed skepticism, pointing out that the FDA inspected the NECC three times since 2002 and issued a warning letter to the company in 2006, but never shut the operation down.
"I think a lot of the questioning you're seeing here reflects a skepticism on the part of Congress and the public about whether FDA will use this enhanced authority more than it's used the authority it's had to date," said Sen. Richard Blumenthal, D-Conn.
The Massachusetts pharmacy has been closed since early last month, and state officials have taken steps to permanently revoke its license.
Senators invited NECC co-owner and lead pharmacist Barry Cadden to testify Thursday, but he declined to appear. A day earlier Cadden was compelled by subpoena to appear before at a House of Representatives hearing. Cadden repeatedly invoked his Fifth Amendment right to not answer questions in order to avoid self-incrimination.
Federal authorities have opened an investigation on Cadden and the NECC.
FDA inspections in the wake of the outbreak found a host of potential contaminants at NECC's facility, including standing water, mold and water droplets. Compounded drugs are supposed to be prepared in temperature-controlled clean rooms to maintain sterility.