Newly released documents add vivid detail to the emerging portrait of
the Food and Drug Administration's ineffective and halting efforts to regulate a
Massachusetts company implicated in a national meningitis outbreak that has sickened nearly 500 people and killed 34. In the documents,
released on Tuesday in response to a Freedom of Information Act request, the
agency would threaten to bring the full force of its authority down on the
company, only to back away, citing lack of jurisdiction.
The company, the New England Compounding Center, at times cooperated
with F.D.A. inspectors and promised to improve its procedures, and at other
times challenged the agency’s legal authority to regulate it, refused to
provide records and continued to ship a drug in defiance of the agency’s
concerns. Some of the documents were summarized last week by Congressional
committees that held hearings on the meningitis outbreak. Republicans and
Democrats criticized the F.D.A. for failing to act on information about unsafe
practices at the company as far back as March 2002.
By law, compounding pharmacies are regulated primarily by the states,
but the pharmacies have grown over the years into major suppliers of some of
the country’s biggest hospitals. The F.D.A. is asking Congress for stronger,
clearer authority to police them, but Republicans have said the agency already
has enough power. Records show that the agency was sometimes slow in pursuing
its own inspection findings. In one case involving the labeling and marketing
of drugs, the agency issued a warning letter to New England Compounding 684
days after an inspection, a delay that the company’s chief pharmacist
complained was so long that some of the letter’s assertions no longer applied
to its operations.
The agency said in a statement Wednesday that it “was not the timeline
we strive for,” but that much of the delay was because of “our limited, unclear
and contested authority in this area.” Because of litigation, it said, there
was “significant internal discussion about how to regulate compounders.” The
agency first inspected the company in April 2002 after reports that two
patients had become dizzy and short of breath after being injected with a steroid made by the company. On the first day of the inspection, Barry Cadden, the
chief pharmacist, was cooperative, but the next day, the agency inspectors wrote,
Mr. Cadden “had a complete change in attitude & basically would not provide
any additional information either by responding to questions or providing
records,” adding that he challenged their legal authority to be at his pharmacy
at all.
The F.D.A. was back at New England Compounding in October 2002 because
of possible contamination of another of its products, methylprednisolone
acetate, the same drug involved in the current meningitis outbreak. While the
F.D.A. had the right to seize an adulterated steroid, officials at the time
said that action alone would not resolve the company’s poor compounding
practices. In a meeting with Massachusetts regulators, F.D.A. officials left
authority in the hands of the state, which “would be in a better position to
gain compliance or take regulatory action,” according to a memo by an F.D.A.
official summarizing the meeting.
David Elder, compliance branch director for the F.D.A.’s New England
District, warned at the meeting that there was the “potential for serious public
health consequences if N.E.C.C.’s compounding practices, in particular those
relating to sterile products, are not improved.” The company fought back hard,
repeatedly questioning the F.D.A.’s jurisdiction. In a September 2004
inspection over concerns that the company was dispensing trypan blue, a dye
used for some eye surgeries that had not been approved by the F.D.A., Mr.
Cadden told the agency inspector that he had none in stock.
But in the clean room, the inspector noticed a drawer labeled “Trypan
Blue,” which contained 189 vials of the medicine. A few days later, Mr. Cadden
was defiant. He told the agency that he was continuing to dispense trypan blue
and that there was nothing in the law saying a compounder could not dispense
unapproved products. The conversation turned testy. “Don’t answer any more
questions!” Mr. Cadden told another pharmacy executive, according to the
F.D.A.’s report. Mr. Cadden rejected many of the assertions in the warning
letter that finally came in December 2006. The next correspondence from the
agency did not come until almost two years later, in October 2008, saying that
the agency still had “serious concerns” about the company’s practices, and that
failing to correct them could result in seizure of products and an injunction
against the company and its principals. It is not known whether any corrective
actions were taken. The agency did not conduct another inspection until the
recent meningitis outbreak.
Source: NY Times
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