http://mobile.reuters.com/article/idUSBRE8AK0T520121121?irpc=932
REUTERS
Wed, Nov 21 14:28 PM EST FiDA
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By Tim McLaughlin
BOSTON (Reuters) - The U.S. Food and Drug
Administration took 684 days to issue a warning letter after uncovering
infractions that could potentially harm patients at the pharmacy at the center
of the deadly U.S. meningitis outbreak, newly released documents show.
The New England Compounding Center (NECC) chastised the FDA
in a letter dated January 5, 2007, telling the agency its response time was nearly
18 months longer than the FDA's average response, according to letters released
under an open records request.
"We believe that FDA's nearly two year
delay in issuing the Warning Letter contradicts FDA's rhetoric regarding the
asserted risks associated with our compounded products," NECC co-owner and
chief pharmacist Barry Cadden said in the letter, released by the FDA under an
open records request.
The FDA acknowledged in a letter to Cadden
dated October 31, 2008, that there had been a "significant delay" in
its response but insisted that the delay "in no way diminishes our serious
concerns about your firm's operations."
On Wednesday, a spokeswoman for the FDA, Erica
Jefferson, said the delay
in issuing the warning letter was due to the agency's limited, unclear and
contested authority.
"During the time between the inspection of
NECC and the issuance of the warning letter, there was ongoing litigation
pertaining to pharmacy compounding and significant internal discussion about
how to regulate compounders, all of which delayed FDA," she said.
The FDA has asked lawmakers to clarify its authority to oversee
large-scale drug compounders such as NECC. But several Republicans have argued that the agency already
had the authority that could have prevented the outbreak.
And on November 19, a congressional panel
investigating the outbreak told the FDA not to expect new authority until it
releases documents about its role.
According to the Centers for Disease Control
and Prevention, 34 people
have died and 490 have been injured after Framingham,
Massachusetts-based NECC shipped a tainted steroid, methylprednisolone acetate,
to medical facilities throughout the United States. The steroid is typically
used to ease back pain.
On Tuesday, defense lawyers for NECC's owners
told a U.S. District Judge in Boston there was nothing to show they had a
direct hand in the cause of the meningitis outbreak.
INDIGNANT
AND UNCOOPERATIVE
NECC has consistently pushed back against
attempts by regulators to discipline it, despite a series of violations dating back to 1999.
And the pharmacy's principals have sometimes
shown little respect for
the FDA or its inspectors.
During a re-inspection of the pharmacy in 2004
following up on certain marketing and packaging violations, Cadden and his
brother-in-law, Gregory Conigliaro, a co-owner of NECC, became indignant,
according to a 2005 memorandum from the FDA inspector. Cadden declined to
cooperate without speaking to a lawyer first and at one point instructed his brother-in-law
not to answer any more questions.
Conigliaro said he had "a lot of things to
finish and just did not have the time to sit with us to answer our
questions," the inspector said in his memo.
The FDA's eventual warning letter to NECC in
December 2006 was based on an inspection that began in September 2004 and ended
on January 19, 2005, according to the documents.
(Reporting by Tim McLaughlin; Editing by
Jeffrey Benkoe and Andre Grenon)
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