The New England Compounding Center in Framingham, Mass., is being investigated in a fungal meningitis outbreak.(Photo: Jared Wickerham, Getty Images)
WASHINGTON (AP) - Nearly a decade ago, federal health inspectors
wanted to shut down the pharmacy linked to a recent deadly meningitis
outbreak until it cleaned up its operations, according to congressional
About 440 people have been sickened by contaminated
steroid shots distributed by New England Compounding Center, and more
than 32 deaths have been reported since the outbreak began in September,
according to the Centers for Disease Control and Prevention. That has
put the Framingham, Mass.-based pharmacy at the center of congressional
scrutiny and calls for greater regulation of compounding pharmacies,
which make individualized medications for patients and have long
operated in a legal gray area between state and federal laws.
House Energy and Commerce Committee released a detailed history of
NECC's regulatory troubles on Monday, ahead of a meeting Wednesday to
examine how the outbreak could have been prevented. The 25-page report
summarizes and quotes from FDA and state inspection memos, though the
committee declined to release the original documents.
shows that after several problematic incidents, Food and Drug
Administration officials in 2003 suggested that the compounding pharmacy
be "prohibited from manufacturing" until it improved its operations.
But FDA regulators deferred to their counterparts in Massachusetts, who
ultimately reached an agreement with the pharmacy to settle concerns
about the quality of its prescription injections.
congressional report also shows that in 2003 the FDA considered the
company a pharmacy. That's significant because in recent weeks public
health officials have charged that NECC was operating more as a
manufacturer than a pharmacy, shipping thousands of doses of drugs to
all 50 states instead of small batches of drugs to individual patients.
Manufacturers are regulated by the FDA and are subject to stricter
quality standards than pharmacies.
The report offers the most
detailed account yet of the numerous regulatory complaints against the
pharmacy, which nearly date back to its founding in 1998. Less than a
year later, the company was cited by the state pharmacy board for
providing doctors with blank prescription pads with NECC's information.
Such promotional items are illegal in Massachusetts and the pharmacy's
owner and director, Barry Cadden, received an informal reprimand,
according to documents summarized by the committee.
subject to several other complaints involving unprofessional conduct in
coming years, but first came to the FDA's attention in 2002. Here are
some key events from the report highlighting the company's early
troubles with state and federal authorities:
-- In March of 2002
the FDA began investigating reports that five patients had become dizzy
and short of breath after receiving NECC's compounded betamethasone
repository injection, a steroid used to treat joint pain and arthritis
that's different from the one linked to the current meningitis outbreak.
inspectors visited NECC on April 9 and said Cadden was initially
cooperative in turning over records about production of the drug. But
during a second day of inspections, Cadden told officials "that he was
no longer willing to provide us with any additional records," according
to an FDA report cited by congressional investigators. The inspectors
ultimately issued a report citing NECC for poor sterility and
record-keeping practices but said that "this FDA investigation could not
proceed to any definitive resolution," because of "problems/barriers
that were encountered throughout the inspection."
-- In October of
2002, the FDA received new reports that two patients at a Rochester,
N.Y., hospital came down with symptoms of bacterial meningitis after
receiving a different NECC injection. The steroid, methylprednisolone
acetate, is the same injectable linked to the current outbreak and is
typically is used to treat back pain. Both patients were treated with
antibiotics and eventually recovered, according to FDA documents cited
by the committee.
When officials from the FDA and Massachusetts
Board of Pharmacy visited NECC later in the month, Cadden said vials of
the steroid returned by the hospital had tested negative for bacterial
contamination. But when FDA scientists tested samples of the drug
collected in New York they found bacterial contamination in four out of
14 vials sampled. It is not entirely clear whether FDA tested the same
lot shipped to the Rochester hospital.
-- At a February 2003
meeting between state and federal officials, FDA staff emphasized "the
potential for serious public consequences if NECC's compounding
practices, in particular those relating to sterile products, are not
improved." The agency issued a list of problems uncovered in its
inspection to NECC, including a failure to verify if sterile drugs met
But the agency decided to let Massachusetts
officials take the lead in regulating the company, since pharmacies are
typically regulated at the state level. It was decided that "the state
would be in a better position to gain compliance or take regulatory
action against NECC as necessary," according to a summary of the meeting
quoted by investigators.
The FDA recommended the state subject
NECC to a consent agreement, which would require the company to pass
certain quality tests to continue operating. But congressional
investigators say Massachusetts Board of Pharmacy did not take any
action until "well over a year later."
-- In October 2004, the
board sent a proposed consent agreement to Cadden, which would have
included a formal reprimand and a three-year probationary period for the
company's registration. The case ended without disciplinary action in
2006, when NECC agreed to a less severe consent decree with the state.
Massachusetts officials indicated Tuesday they are still investigating why NECC escaped the more severe penalty.
will not be satisfied until we know the full story behind this
decision," the state's interim health commissioner Lauren Smith said in a
transcript of her prepared testimony released a day ahead of delivery.
Smith is one of several witnesses scheduled to testify Wednesday,
including FDA Commissioner Margaret Hamburg.
The committee will
also hear from the widow of 78-year-old Eddie C. Lovelace, a longtime
circuit court judge in southern Kentucky. Autopsy results confirmed
Lovelace received fungus-contaminated steroid injections that led to his
death Sept. 17.
Joyce Lovelace will urge lawmakers to work
together on legislation to stop future outbreaks caused by compounded
drugs, according to a draft of her testimony.
"We now know that
New England Compounding Pharmacy, Inc. killed Eddie. I have lost my
soulmate and life's partner with whom I worked side by side, day after
day for more than fifty years," Lovelace states.
Barry Cadden is also scheduled to appear at the hearing, after lawmakers issued a subpoena to compel him to attend.
NECC has been closed since early last month, and Massachusetts
officials have taken steps to permanently revoke its license. The
pharmacy has recalled all the products it makes, including 17,700
single-dose vials of a steroid that tested positive for the fungus tied
to the outbreak.