According to a report by Christina Jewett of ProPublica and Deborah L. Shelton of the Chicago Tribune, the U.S. Food and Drug Administration — understaffed, overworked and increasingly reliant upon the cooperation and assistance of the industries it’s expected to oversee — allowed a North Carolina plant to ship tainted syringes which have “been linked to at least 4 deaths and 162 illnesses nationwide.”
The reporters chronicle the, the series of FDA internal safeguards that failed to catch the syringes before they were shipped.
- In October 2007, an inspector visited the plant after reports of specks of debris in fluid-filled syringes. She reported that management had a plan to deal with the problem, not noting that their sterilization method was unreliable.
- The company, AM2PAT, announced a recall a week later. This should have triggered an automatic FDA review but the overloaded agency ignores that particular fail-safe unless it judges lives to be on the line.
- In late 2007, as folks started getting sick, the FDA finally gave the plant a detailed inspection, finding a gummy brown substance on the syringe filler and brown water coming from the taps. It was closed in January 2008, but the damage had already been done.
The reporters found the regulatory failures were the cumulative effect of overwork and an increasingly heavy reliance on industry to police itself.
For this article, Gordon Harnack, a consultant who helps medical device companies prepare for inspections, reviewed more than 120 pages of FDA reports on the AM2PAT plant dating to 2005. He said inspectors didn’t look deep enough, and FDA managers were too tolerant.
“Time after time, the evidence was there that [AM2PAT] management had little intent of complying with adequate FDA regulations,” Harnack said. “In 2005, [the FDA] might have caught it. In 2007, they should have caught it. And finally when reports of deaths came in, it all became evident.”
The Propublica/Tribune report exhaustively chronicles AM2PAT’s fraud and manipulation of the system, a history of deception which the FDA failed to act on until it was too late.