Pharmaceutical

FDA should have acted faster to prevent contamination

Leslie Fullerton provided the best care he could for his 29-month-old daughter Natalie with the medical equipment and medications provided him, but he still blames himself for her death. The little girl had already undergone a double-lung transplant and was recovering nicely when her father, following instructions of his daughter’s health care provider, used a pre-filled syringe to clean the tube implanted in Natalie’s chest to give her intravenous medication. Days later, Natalie became breathless and feverish as a bacteria infected her blood. Months later, Natalie died.

Investigators now know that the pre-filled heparin and saline syringe Fullerton used was part of a contaminated lot that has since been linked to at least four deaths and 162 illnesses. And that lot could have and should have been prevented from being shipped to hospitals by the Food and Drug Administration (FDA).

Months before the syringes were shipped out, the FDA received reports about debris in syringes filled with heparin and saline distributed by drug manufacturer AM2PAT, yet the agency didn’t follow up on the complaints until 2007 after the reports of deaths and illnesses following use of the syringes. Reports from 2007 inspections show that investigators found a “gummy brown” substance on the syringe-filling machine. The plant was closed in January 2008.

Consumer advocates say the FDA should have acted faster and more aggressively to prevent the contamination of the pre-filled syringes at AM2PAT. Congress, too, has been critical of the agency for not properly or adequately inspecting food and drugs that are distributed to American hospitals and health care centers, and are pushing for better inspection standards within the agency.

Source: Pro Publica