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 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 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 a drug in defiance of the agency’s concerns.
By law, compounding pharmacies are regulated primarily by the states, but the pharmacies have grown into major suppliers of some of the country’s biggest hospitals.
