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.
