In the documents, released Tuesday in response to a Freedom of Information Act request, the Food and Drug Adminstration would threaten to bring the full force of its authority down on the company implicated in the outbreak, only to back away, citing lack of jurisdiction.
The company, the New England Compounding Center, at times cooperated with FDA inspectors and promised to improve its procedures, and at other times challenged the agencys legal authority to regulate it, refused to provide records and continued to ship a drug in defiance of the agencys concerns.
Some of the documents were summarized last week by congressional committees that held hearings on the meningitis outbreak. Republicans and Democrats criticized the FDA 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 into major suppliers of some of the countrys biggest hospitals. The FDA 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 companys chief pharmacist complained was so long that some of the letters 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, 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 FDA 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 FDA had the right to seize an adulterated steroid, officials at the time said that action alone would not resolve the companys poor compounding practices. In a meeting with Massachusetts regulators, FDA 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 FDA official summarizing the meeting.