The U.S. House of Representatives' 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 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.
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