Congress widens scrutiny of meningitis outbreak to regulator

WASHINGTON Fri Oct 12, 2012 7:53pm EDT

1 of 4. 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.

Credit: Reuters/Jessica Rinaldi

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WASHINGTON (Reuters) - The House of Representatives on Friday widened its investigation into the deadly meningitis outbreak to include the role health regulators played in monitoring the pharmacy that produced steroid treatments suspected of causing the crisis.

The House Energy 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 sterile injectable steroid treatments for back and joint pain from health facilities in 23 states. Massachusetts board officials were not immediately available for comment.

The 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 NECC in 2006, including potential public health risks involving a different sterile injectable drug.

The rare fungal form of meningitis has killed 14 people in 12 states, with the first case reported in Texas on Friday. The number of cases nationwide reached 184, an increase of 15 from Thursday, CDC said.

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 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.

CONGRESSIONAL BRIEFINGS

The committee also has asked for briefings from NECC and has had what an aide called "several preliminary discussions" with FDA and the U.S. Centers for Disease Control and Prevention.

One of the nearly 14,000 patients given potentially tainted injections of pain medicine has sued the maker of the treatment in the first of a wave of lawsuits.

The lawsuit was filed in a Minnesota federal court on Thursday by a woman who said she was given a steroid injection for back pain and has experienced symptoms consistent with meningitis. She is awaiting the results of tests.

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 NECC 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.

An FDA official at a briefing on Thursday said NECC assured the agency that it was producing safe products. Also at that briefing, Massachusetts health regulator Dr. Madeleine Biondolillo said the company appeared to have flouted state laws for pharmacies.

She said the state inspected of NECC facilities in 2011 and currently is investigating a complaint from March. She provided no details.

14,000 AT RISK

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.

Of the 14,000 people at risk of infection, medical practitioners still were trying to reach about 2,000 patients to warn them to be tested immediately.

"We are not out of the woods yet," Dr. Todd Weber, manager of the CDC response to the meningitis outbreak, said during a briefing on Thursday.

While most of the patients at risk received epidural injections to alleviate back pain, the CDC said patients who received injections in joints such as a knee or ankle also should be checked.

They disclosed that a Michigan patient had developed an infection after an injection in an ankle. Tests have not yet been completed to determine if it is a fungal infection.

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.

Most people infected so far have displayed symptoms within two weeks of receiving the medication and as long as 42 days afterward. They cautioned that patients should be vigilant for several months if they received one of the injections.

Health officials in Tennessee, the state with the most cases, said on Friday that a facility there may have received one of the suspect shipments of medication as early as the beginning of June. There could be 111 more patients needing testing who were not on the original list of those at risk, they said.

More than 50 vials of the steroid, out of more than 17,000, had so far been confirmed as contaminated with more tests under way, health authorities said.

The lawsuit is Barbe Puro v. New England Compounding Pharmacy Inc, U.S. District Court, District of Minnesota, No. 12-2605.

(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)

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