* Health officials in 2003 left NECC under state oversight
* Issue central to lawmaker debate over meningitis outbreak
* House Republicans say NECC had long history of misconduct
* House and Senate hearings scheduled for this week
By David Morgan
WASHINGTON, Nov 12 Government health regulators
in 2003 told the pharmacy now at the center of a deadly
meningitis outbreak that its drug compounding activities did not
constitute a manufacturing operation that would merit strict
federal safety standards, a congressional report said on Monday.
The report by the Republican staff of a U.S. House of
Representatives committee, said the Food and Drug Administration
and Massachusetts state officials decided to leave oversight of
the New England Compounding Center to a state pharmacy board,
despite evidence of health problems linked to two drugs in 2002.
One of the drugs was methylprednisolone acetate, the same
steroid treatment health officials have identified as the source
of a current U.S. fungal meningitis outbreak that the U.S.
Centers for Disease Control and Prevention says has grown to 438
cases, including 32 deaths, in 19 states.
Where to draw the line between drug manufacturing and drug
compounding is a central question for U.S. lawmakers, who will
hold separate House and Senate hearings this week as part of two
investigations to determine whether the FDA should be given
stronger authority to regulate compounding operations.
The House Energy and Commerce Committee, which produced the
Republican report, is scheduled to hold its hearing on Wednesday
with testimony expected from FDA Commissioner Margaret Hamburg,
interim Massachusetts health commissioner Lauren Smith and NECC
co-owner Barry Cadden, who has been subpoenaed to appear.
A separate hearing before the Senate Health, Education,
Labor and Pensions Committee is scheduled for Thursday with a
similar roster of witnesses expected.
A handful of Democrats have called for new legislation to
strengthen federal oversight of the compounding industry, in
which pharmacists traditionally alter or recombine drugs to meet
the special needs of specific patients.
Drug compounding has evolved in recent decades to include
large-scale production that some experts view as drug
manufacturing that should be subject to FDA regulation.
But the compounding industry is currently overseen mainly by
state authorities that are often ill-equipped for the job.
Up to now, compounding pharmacies have waged long legal and
lobbying battles to stave off federal regulation. And some in
Congress worry that failure to act before the end of the current
lame duck session could postpone legislation in 2013 and risk
losing momentum driven by the growing number of cases.
The advocacy group Public Citizen earlier this month called
on the Obama administration to launch an independent probe into
FDA's lack of action against NECC. The group alleges that FDA
already has the authority it needs, but that agency officials
failed to take steps that could have prevented the current
Responding to a Reuters query about Public Citizen's claims,
the Department of Health and Human Services, which oversees FDA,
said the agency has limited powers over compounders and urged
Congress to strengthen its authority.
The House Republican report does not say how health
officials determined NECC to be a pharmacy instead of a
manufacturer. But the decision came after NECC had doubled its
production space and begun pursuing a marketing strategy that
called for selling compounded drugs to customers in all 50
"It was decided that 'current findings supported a
compounding role' and that 'the state would be in a better
position to gain compliance or take regulatory action against
NECC as necessary'," said the report.
The decision came at a Feb. 5, 2003 meeting between FDA and
state officials that ended with federal regulators emphasizing
the potential for "serious public health consequences" if NECC's
compounding practices, in particular those relating to sterile
products, did not improve.
"It is noteworthy that after closing out the inspection ...
FDA's primary NECC investigator and her supervisor recommended
that the 'firm be prohibited from manufacturing until they can
demonstrate ability to make product reproducibly and
Cadden was informed soon after the meeting that FDA did not
consider his company to be a manufacturer. On Feb. 26, 2003, he
responded in writing to an FDA document calling for corrective
measures at NECC by saying: "We are not subject to (nor are we
voluntarily subjecting ourselves to) current good manufacturing
practices as promulgated by FDA, since we are a compounding
pharmacy, not a manufacturer."
The decision to leave oversight largely to state officials
also followed an April 2002 encounter between FDA investigators
and Cadden in which the report said the NECC executive
challenged the FDA's authority to be at his pharmacy and refused
to provide information or records to the federal agency.
But problems continued at NECC, and the FDA finally issued a
warning letter in 2006 warning that the company's compounding
operations had begun to resemble manufacturing operations and
still posed potential health risks from the compounding of
"NECC has a long history of very similar, if not identical,
underlying misconduct," said the congressional report.
"Some of the violations observed by regulators as early as
2002 include the company's failure to maintain adequate
safeguards for sterile injectable products -- the very issue at
the center of the current meningitis outbreak."
On Monday, FDA said it discovered insects, a flying bird and
other unsanitary conditions at NECC's sister company, Ameridose