Compounding pharmacies are major suppliers of infusable and injectable solutions used by some of the nation's biggest hospitals. As the recent meningitis outbreak shows, contamination of these products can lead to disasterous results for patients. Nearly 500 people have been sickened and 34 killed by the meningitis outbreak, causing many to wonder about the role of the Food and Drug Administration in regulating compounding pharmacies.
By law, compounding pharmacies are regulated primarily by the states. The Congressional investigation of the New England Compounding Center (NECC), the compounding pharmacy at the center of the meningitis crisis, is shedding light on the need to clarify the authority of the FDA to regulate these manufacturers of compounded solutions. As reported in the New York Times, documents released last Tuesday, illustrate the FDA's current impotence with respect to compounding pharmacies.
The FDA had information about unsafe practices and unsterile conditions at the NECC as far back as March 2002. The FDA inspected on numerous occasions the NECC facility. The FDA first inspected NECC 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.
It sure sounds like Mr. Cadden consulted with NECC's lawyers between the inspection and the next day, was advised that the law is unclear whether the FDA had the authority to require that Cadden produce information, and was instructed not to cooperate.
The NECC, at times cooperated with FDA 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 product in defiance of the agency’s concerns.
The FDA is not without blame. 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 NECC 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 following excerpt from the New York Times article shows the NECC's utter disregard of the FDA:
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.
The next time the FDA conducted another inspection of the NECC compouning facility was after the meningitis outbreak. The FDA is currently asking Congress for stronger, clearer authority to police compounding pharmacies, but some in Congress have said the agency already has enough power. Let's not forget that in the early 1990's Newt Gingrich and others proposed eliminating the FDA and letting the pharmaceutical companies police themselves. Is cronyism once again getting in the way of public safety? Another question is, why were the Massachusetts state inspectors not up to the job of regulating this company?
P.S. Last Thursday, the FDA released the results of testing of additional steroid products compounded by NECC, finding more contaminants (fungal growths and bacteria) in additional drugs. Consequently, the FDA updated its list of lot numbers for contaminated drugs produced by New England Compounding Center.