The Food and Drug Administration is defending its actions regarding a sterile lubricating jelly that was recalled due to potential sterilization problems. The agency was criticized for failing to take the appropriate steps to contain the public health hazard, according to an MSNBC news report.
Critics of the FDA say the agency knew and reported that Triad Group, the company responsible for manufacturing the product, had contamination and sterilization issues but did not act aggressively enough until a hospital infection took the life of a two-year-old boy in Houston, according to the report.
In response, Michael Rogers, acting director of the Office of Regional Operations for the FDA, said the agency closely monitored the company in July 2009, April 2010 and May 2010 and tried to act swiftly to contain the sales of the jelly product following the toddler's death. Mr. Rogers added the FDA wanted to work collaboratively with the firm to correct problems related to contamination and sterilization, including broken equipment and lack of proper sterilization.
"Neither of those two inspections revealed information or evidence that allowed the agency to make conclusions that there was an imminent health hazard," Mr. Rogers said. He added if evidence suggested more concerns with sterilization, the FDA would have taken different actions with Triad Group, according to the report.
Read the MSNBC news report about the FDA and Triad Group's recall.
Read other coverage about the FDA:
- FDA Approves Mindray Medical Anesthesia System
- Triad Sterile Lubricating Jelly Recalled
- House Hears Arguments Over FDA's Medical Device Approval Process
Critics of the FDA say the agency knew and reported that Triad Group, the company responsible for manufacturing the product, had contamination and sterilization issues but did not act aggressively enough until a hospital infection took the life of a two-year-old boy in Houston, according to the report.
In response, Michael Rogers, acting director of the Office of Regional Operations for the FDA, said the agency closely monitored the company in July 2009, April 2010 and May 2010 and tried to act swiftly to contain the sales of the jelly product following the toddler's death. Mr. Rogers added the FDA wanted to work collaboratively with the firm to correct problems related to contamination and sterilization, including broken equipment and lack of proper sterilization.
"Neither of those two inspections revealed information or evidence that allowed the agency to make conclusions that there was an imminent health hazard," Mr. Rogers said. He added if evidence suggested more concerns with sterilization, the FDA would have taken different actions with Triad Group, according to the report.
Read the MSNBC news report about the FDA and Triad Group's recall.
Read other coverage about the FDA:
- FDA Approves Mindray Medical Anesthesia System
- Triad Sterile Lubricating Jelly Recalled
- House Hears Arguments Over FDA's Medical Device Approval Process