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Congress expands probe into meningitis outbreak

By DAVID MORGAN | Reuters
October 13, 2012

A security guard looks out from the front doors of pharmaceutical compounding company New England Compounding Center (NECC), a producer of the steroid methylprednisolone acetate, in Framingham, Massachusetts October 8, 2012.
(REUTERS/Jessica Rinaldi)

Lawmakers on Friday widened their investigation into the deadly meningitis outbreak to include the role state regulators played in monitoring the pharmacy that produced steroid treatments blamed for killing 14 people in six states.

The U.S. House of RepresentativesEnergy and Commerce Committee called on the Massachusetts pharmacy board to tell congressional staff what it knew about the New England Compounding Center before the recall of more than 17,000 vials of injectable steroid treatments for back and joint pain from health facilities in 23 states.

Separately, New England Compounding, which voluntarily gave up its license in Massachusetts after it was identified as the likely source of the outbreak, started to shed employees.

The suburban Boston company has cut more than half of its workforce, or about 40 employees.

New England Compounding, which had been licensed in 49 states, is expected to face a torrent of regulatory action and lawsuits.

As past regulatory actions came into focus the U.S. House panel, which oversees health issues including drug safety, said the U.S. Food and Drug Administration was aware of production problems at Framingham, Massachusetts-based firm in 2006, including potential public health risks involving a different sterile injectable drug.

The Senate Health, Education, Labor and Pensions Committee said it would seek information next week from “critical stakeholders” involved in the outbreak, following a closed-door Friday briefing from the staff of the FDA and U.S. Centers for Disease Control and Prevention.

MULTIPLE INVESTIGATIONS UNDER WAY

The rare fungal form of meningitis has now infected 184 people in 12 states, with Texas reporting its first case on Friday.

The outbreak is a major national health scandal, with multiple investigations under way and a leading Democratic lawmaker, Senator Richard Blumenthal of Connecticut, calling for a criminal investigation of the company.

The House committee asked the Massachusetts regulator to agree to a briefing no later than October 19 and requested all inspection reports, records and communications related to New England Compounding Center (NECC) and its sister pharmacy, Ameridose LLC, which has the same owners.

“The committee is investigating whether any remedial measures were taken after this inspection and why the NECC was able to continue operating in this manner more than six years after the fact,” Republican Fred Upton, the committee chairman, said in a letter co-authored by six other panel members.

The Massachusetts agency did not comment directly on the committee’s request for information, but the state health department said that it had taken swift action in response to the meningitis outbreak.

The specialist pharmacy appears to have violated the licensing regulation that restricted their production to the receipt of “individual patient-specific prescriptions,” the department said in a statement. “We are jointly examining all root causes of these events with the FDA.”

Late on Friday, Michigan suspended the company’s license in the state, which is among the hardest hit in the outbreak.

Attorney General Bill Schuette’s office alleged that the specialist pharmacy was acting as a drug manufacturer – distributing large amounts of medication to hospitals and clinics – while licensed only to fill individual prescriptions for patients in the state.

FDA WANTS EXPANDED OVERSIGHT

Lawmakers and organizations including the advocacy group Public Citizen have raised questions about whether the FDA and Massachusetts regulators had the knowledge and authority to act against New England Compounding before the outbreak occurred.

The compounding company has recalled the suspect product, surrendered its operating license and has said it is cooperating with the investigations.

The regulatory issue involves a little-known segment of the pharmacy industry called drug-compounding, in which pharmacists alter or recombine ingredients from FDA-approved drugs to meet the special needs of doctors and their patients.

Pharmacies like NECC are allowed to compound drugs for specific prescriptions, mainly under the supervision of state pharmacy boards rather than the more stringent safety and efficacy standards that the FDA imposes.

FDA officials have called for a new regulatory framework, saying the agency’s power to oversee compounding pharmacies is limited, partly as the result of legal challenges that have popped up in courts across the country over more than a decade.

The House committee noted a 2006 FDA letter that said NECC’s actions were not consistent with traditional compounding practices and likened the operation to a drug manufacturer.

The CDC is working furiously to contain the meningitis outbreak from medications shipped to 23 states. Deaths have been reported in Tennessee, Florida, Michigan, Indiana, Maryland and Virginia.

Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms include headache, fever and nausea and it must be treated quickly to improve chances of survival. Fungal meningitis is a rare form and is not contagious.

(Reporting by David Bailey, Toni Clarke, Ros Krasny, Aaron Pressman, Grant McCool, and Tim Ghianni; Writing by Greg McCune; Editing by Lisa Shumaker and Bill Trott)

Copyright 2012 Thomson Reuters. All rights reserved.

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