(Corrects to say fatalities in six states, not 12)
* House panel wants input on problems at meningitis-linked
firm
* Committee seeks information on any "remedial measures" at
NECC
WASHINGTON, Oct 12 (Reuters) - The U.S. 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
six 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 Oct. 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)
