Overview: Newly released documents add to more to the story behind the fungal meningitis outbreak that has sickened 500 people and killed 34. On Tuesday, documents released in response to a Freedom of Information Act request detailed correspondence between the U.S. Food and Drug Administration (FDA) and the New England Compounding Center (NECC), who distributed the tainted vials of steroid injections across the country. The information reveals the FDA’s failed attempts at regulating the compounding company, reports the New York Times.
- Documents show that the FDA failed to regulate NECC, who distributed vials of contaminated steroid injections
- Among other things, the documents show that NECC at times challenged the FDA by shipping a drug despite agency concerns
- The fungal meningitis outbreak has sickened some 500 people and killed 34
Documents Show FDA Delayed Response
According to an article in the New York Times, the documents track correspondence between the FDA and Massachusetts-based NECC as early as 2002, when the agency decided to inspect the company over reports of two patients who became dizzy and short of breath after receiving its injections. Chief pharmacist Barry Cadden was reportedly cooperative on the first day of inspection, but following that appeared to have “a complete change in attitude & basically would not provide any additional information either by responding to questions or providing records”. Later that year, the FDA revisited the facility due to possible contamination of some of its products. Methylprednisolone acetate, the steroid injection implicated in the meningitis outbreak, was one of the products in question.
Although the FDA has the right to seize the steroid, the agency said that their actions would not help improve the company’s practices and left the responsibility to the state.
Meningitis Outbreak Background
The New England Compounding Center recalled over 17,000 vials of preservative-free methylprednisolone acetate following reports of patients who developed fungal meningitis after receiving the injections for back pain. The deadly outbreak has raised questions about industry practices and regulatory power, particularly with regards to the FDA monitoring compounding companies. Unlike manufacturers, who are regulated by the FDA, compounding companies are regulated by the state and dodge a number of restrictions that are normally placed on manufacturers.