By Tim McLaughlin
BOSTON Nov 21 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 Jan. 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
"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 Oct. 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 Nov. 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 Jan. 19, 2005, according to the documents.