Could FDA Have Stopped the Bacterial Infections Traced to NECC?
August 15th, 2013 // 5:57 pm @ jmpickett
Latest FDA and cGMP Compliance News
Is it possible that FDA could have stopped a bacterial infection outbreak that was traced recently to a compounding pharmacy?
This is believed to be the case by a certain consumer watchdog that has noted that FDA issued a 483 report last year that showed that Specialty Compounding in Dallas did not take proper steps to stop microbiological contamination, along with other cGMP problems. However, FDA failed to send out any safety notices and did not pressure the firm to do a recall.
However, there was a product recall this week, after the agency got 15 bacterial infection reports at two hospitals in Texas that could have been related to Specialty’s calcium gluconate infusions. FDA warned that any drugs that were gotten from this compounder since May should not be used.
However, a letter to the DHHS Secretary, Kathleen Sebelius, which was sent by Public Citizen, stated that FDA should have taken more actions to stop the infections after the recent cGMP audit. Public Citizen also wants the secretary to order the OIG to investigate why the agency failed to push the compounding pharmacy to do a recall.
Public Citizen also is requesting that HHS push FDA to do a review of many other compounding pharmacies that also had cGMP audits in recent months. It wants to see similar actions taken against any other pharmacy that had similar sterility issues.
Public Citizen stated that FDA was aware there was a very serious problem but it failed to use its legal authority to take aggressive action against the compounding pharamcy. Public Citizen asked: What is the point of doing a CGMP inspection if you won’t take action when there is a safety threat to consumers?
There have been inspection reports issued for about 50 compounding pharmacies, but just 15 have had a recall or had an FDA warning letter or 483 issued.
The reason the cGMP audits took place was because of the serious fungal meningitis outbreaks that happened last year. These were traced in the end to New England Compounding Center. The outbreak caused 61 deaths and 750 cases of infection. It is thought to be the worst crisis of public health in 50 years in the US.
The scandal caused a big debate about how much oversight the agency should have over drug compounding pharmacies. FDA is lobbying Congress for a law that could provide it with more enforcement and oversight powers.
