By DENISE GRADY and SABRINA TAVERNISE
Published: November 12, 2012
A federal inspection has turned up a long list of
unsanitary conditions and unsafe practices at Ameridose, a drug supplier with
some of the same owners as the pharmacy whose tainted steroid
caused a nationwide outbreak of fungal meningitis
that has killed 32 people and sickened more than 400 others.
Inspectors also said the company failed to “adequately
investigate” complaints of serious reactions in patients that might have
indicated problems with drug potency — reactions including fetal distress, a
hyperstimulated uterus and maternal hemorrhaging from a drug used in labor, and
oversedation and breathing trouble from fentanyl, a powerful narcotic. There
were also complaints of low potency in a sedative
used to relieve anxiety
in children undergoing surgery.
“F.D.A. inspectors observed conditions and practices
at Ameridose which demonstrated that the firm could not consistently assure that
their injectable products were sterile and safe for use by patients,” Sarah
Clark-Lynn, a spokeswoman for the agency, said in an e-mail.
So far, Ms. Clark-Lynn said, no infections have been
linked to Ameridose, but all its products have been recalled, and its operations
have been suspended since early October at the request of state regulators, who
say they need more time to investigate.
Ameridose said in a statement that it had had no
instances of product contamination in its six-year history, during which it had
shipped “70 million units of product.” However, problems with potency did result
in at least one recall. The company said it was “committed to addressing all
observations in order to enhance our existing systems.”
Eric S. Kastango, the president of Clinical IQ, a
consulting firm that advises compounding pharmacies, said the F.D.A. findings at
Ameridose were “just stupefying.”
“It’s an operation that is totally out of control,” he
said. “Especially when you look at the patient complaints, that is scary as all
get-out.”
Ameridose has been a major supplier of sterile
injectable medications to hospitals and sells more than 2,200 blended drug
products, including tranquilizers, anesthetics and antibiotics,
according to its Web site.
The inspection report dealt another blow to the family
behind Ameridose and its sister company, the New
England Compounding Center, which made the fungal-tainted steroid medication
that caused the meningitis outbreak. The report comes just two days before the
House Committee on Energy and Commerce is scheduled to hold a hearing on the
outbreak. Barry Cadden, the chief pharmacist at the New England center, was
subpoenaed by the committee after he declined its initial request to testify.
Federal officials have said Ameridose was investigated because of concerns that
it had some of the same business practices as New England Compounding.
Ameridose, founded in 2006, is a private company and
is not required to report its financial status publicly. Weeks of no activity
seem to have taken their toll on the company, which has laid off or furloughed
most of its 650 employees, as well as 140 employees of its sales affiliate,
Medical Sales Management.
Ameridose was founded by the same people who owned
the New England Compounding Center — Mr. Cadden, who has since lost his license;
Gregory Conigliaro, a businessman; and Mr. Conigliaro’s sister-in-law, Carla
Conigliaro. It is based in Westborough, Mass.
Robert C. Coleman, a retired F.D.A. investigator, said
in an e-mail that while the inspection report was not the worst he had seen, “I
would not want to use any of the company’s products.”
Mr. Kastango said part of the problem was that
Ameridose, while run by pharmacists, had become a major drug manufacturer,
without the proper procedures for safe mass production.
“It’s just unfathomable that they were able to operate
for as long as they did,” he said, adding that he doubted Ameridose would ever
be able to open for business again.
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