BOSTON (AP)
-- The specialty pharmacy linked to a deadly meningitis outbreak may
have misled regulators and done work beyond the scope of its state
license, Massachusetts Gov. Deval Patrick said Wednesday.
Meanwhile,
a second pharmacy connected to the New England Compounding Center in
Framingham has shut down for state and federal inspection.
The
New England Compounding Center made a steroid that was used in
injections for back pain that were later found contaminated. More than
130 people in 11 states have been sickened. Twelve have died.
On
Wednesday, Patrick told reporters that state and federal agencies "may
have been misled by some of the information we were given" by the New
England Compounding Center.
The company was licensed to fill specific prescriptions for specific patients but exceeded that, he said.
"What
they were doing instead is making big batches and selling them out of
state as a manufacturer would, and that is certainly outside of their
state license," he said.
Massachusetts U.S.
Rep. Ed Markey seized on Patrick's statement, and sent a letter to the
U.S. Food and Drug Administration, asking if it believes it was misled
by the company.
"This company may have
disregarded federal guidelines, and we need to know from the FDA whether
the company misled regulatory authorities and if sanctions against the
company are available or warranted," Markey said.
A
company spokesman declined comment beyond a statement that company
officials are focused on cooperating with the investigation. The company
has shut down operations, recalled the fungus-contaminated steroid and
is cooperating with investigators.
On
Wednesday afternoon, the state announced that the pharmacy Ameridose has
agreed to temporarily shut down, pending inspection by state and
federal regulators. Ameridose was founded in 2006 by Greg Conigliaro and
Barry Cadden, who opened the New England Compounding Center eight years
earlier.
Ameridose said in a statement that
its shutdown ends Oct. 22, though the agreement with the state allows
the shutdown to be extended or shortened. The company said that as part
of the agreement, Cadden has resigned all corporate positions with the
company, where he has not had a day-to-day role.
Ameridose
compounds drugs at one of its two facilities in Westborough, but also
provides medication in prefilled oral syringes to hospitals nationwide.
Dr.
Madeleine Biondolillo, director of the state's Bureau of Healthcare
Safety, said there's no evidence of problems at Ameridose and the state
hasn't requested a recall of any Ameridose products.
A
pharmacy manager at Ameridose, Sophia Pasedis, has been a member of the
regulatory body, the Massachusetts Board of Registration in Pharmacy,
since 2004. But the state said she has rescued herself from all matters
related to Ameridose and the New England Compounding Center.
Compounding
pharmacies supply products that aren't commercially available, based on
an individual doctor's prescription. Some have grown into larger
businesses, operating across state lines and supplying drugs to
thousands of hospitals, clinics and physicians.
Biondolillo
said the state has reminded Massachusetts pharmacies that compounding
can be done only in response to a patient-specific prescription. She
said the state is now requiring all compounding pharmacies to sign an
affidavit that they are following all regulations.
The state has 1,100 pharmacies that can compound drugs.
Massachusetts
last inspected the New England Compounding Center in March in response
to a pending complaint unrelated to the outbreak, officials have said.
It also inspected the pharmacy in 2011 when it moved operations, and
found no problems.
Asked if the state had
tried to determine if the company was making large batches of drugs, a
possible signal it was operating outside the bounds of its license,
Biondolillo said, "Each time we go out and inspect, we're looking at all
aspects of the operation."
She didn't give specifics about what the inspectors found in the most recent visit.
In
Ohio, the state's board of pharmacy on Wednesday suspended the
company's license to distribute in the state, citing evidence that the
company's practices presented a danger of serious and immediate harm to
others.
As many as 13,000 people received
steroid shots from the New England Compounding Center, according to the
federal Centers for Disease Control and Prevention.
Compounded
drugs have never been reviewed for safety and effectiveness by the FDA.
The outbreak has led to calls from lawmakers, including Markey and
Connecticut Rep. Rosa DeLauro, to strengthen the agency's oversight over
the drugs.
Copyright 2012 by The Associated Press. All rights reserved.
