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Fungal Meningitis Outbreak Reveals Oversight Failures

Filed November 26th, 2012 Cynthia Diaz-Shephard

Recently released documents highlight the U.S. Food and Drug Administration’s (FDA) ineffective efforts to regulate the New England Compounding Center (NECC), the pharmaceutical firm responsible for a national fungal meningitis outbreak that has killed 34 people and sickened nearly 500 others.

The documents showed that the FDA threatened to bring the full force of its authority down on the company multiple times, only to pull back, citing lack of jurisdiction, The New York Times said. The documents also revealed that the NECC challenged the agency’s legal authority to regulate it and also refused to provide records and continued to ship a drug despite the agency’s concerns.

Records show that the FDA was slow in following up 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. The delay was so long that some of the letter’s assertions no longer applied, The New York Times said. The documents also showed that the FDA was at the NECC in October 2002 over possible contamination of methylprednisolone acetate, the same drug responsible for the current fungal meningitis outbreak, The New York Times said.

The FDA had the right to seize an adulterated steroid on the spot, but officials said that action alone would not resolve the company’s poor compounding practices. FDA officials instead left authority in the hands of the state, claiming that the state would be in a better position to gain compliance or take regulatory action, according to the New York Times. A 2004 visit also revealed weakness on the part of the FDA. The agency had concerns the company’s distribution of a trypan blue dye, used in eye surgeries, despite not being approved. Chief pharmacist Barry Cadden told the agency that the company was going to continue to dispense the product and there was no law that could stop them.

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