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Updated Friday, November 23, 2012 at 12:16 AM

Documents cite FDA's troubling history with compounding pharmacy

By ANDREW POLLACK and SABRINA TAVERNISE
The New York Times

Newly released documents add detail to the emerging portrait of the Food and Drug Administration's (FDA) 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 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 FDA inspectors and promised to improve its procedures; at other times, it challenged the agency's legal authority to regulate it.

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 to New England Compounding 684 days after an inspection, a delay 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 Wednesday that it "was not the timeline we strive for."

The agency first inspected the company in April 2002.

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," 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 product, methylprednisolone acetate, the same drug involved in the current meningitis outbreak.

While the FDA had the right to seize an adulterated steroid, officials said that action alone would not resolve the firm's poor compounding practices. In a meeting with Massachusetts regulators, FDA officials left authority in the hands of the state.

In a September 2004 inspection over concerns that the company was dispensing trypan blue, a dye used for some eye surgeries that had never been approved by the FDA, Cadden told the agency inspector 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.

Cadden told the agency there was nothing in the law saying a compounder could not dispense unapproved products. He rejected many of the claims in the warning letter that finally came in December 2006. The next correspondence did not come until October 2008, saying the agency still had "serious concerns," about the company's practices.

The agency did not conduct another inspection until the recent meningitis outbreak.


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