Meningitis Outbreak Reveals Regulatory ‘Black Hole’
The number of people infected with a rare type of fungal meningitis has now climbed to 119. Eleven people have died, according to the latest numbers from officials at the Centers for Disease Control and Prevention.
The infections trace back to a contaminated steroid manufactured and distributed by the Framingham-based New England Compounding Center. As many as 13,000 people in 23 states received the injectable steroid to treat back pain. Though health officials do not know how many of the shots could be tainted with fungal meningitis.
The NECC has now voluntarily recalled all its products. This is not the company’s first quality control crisis. In 2002, the NECC was investigated by the FDA and the Massachusetts Board of Pharmacy. It had three prior complaints against it, including a separate investigation involving the potency of a product used in eye surgery procedures.
So how did this happen? And who has oversight over these “compounding centers”?
- Sheldon Bradshaw, Former Chief Counsel at the US Food and Drug Administration, currently a partner at the Washington law firm Hunton & Williams
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