FDA Faces New Round of Questioning Over Compounder Regulation

Posted on April 17, 2013

In the past few weeks, compounders have been recalling sterile products in droves over concerns that said sterility cannot be assured.  Many of those recalls have stemmed from inspections by the Food and Drug Administration that uncovered the types of conditions that could lead to contamination.

Nevertheless, the Commissioner of the FDA feels that current laws leave the agency at a disadvantage when it comes to policing such compounders.  She said as much during questioning yesterday by the House Energy and Commerce Subcommittee on Oversight and Investigations.

Members of that committee lobbed questions the Commissioner’s way in regards to how the organization handled a variety of complaints made about the Massachusetts-based New England Compounding Center.  That company had made available certain steroid injection products that were reportedly contaminated with fungus.  730 people sustained a fungal meningitis infection, and 51 persons are thought to have died because of the illness.

The Commissioner expressed disappointment over the fact that the agency did not more aggressively go after compounders like the NECC, and she has asked for alterations to the law which could improve the FDA’s oversight of such facilities.  At the moment, she believes the FDA’s hands are tied thanks to conflicting laws that allow compounders to dispute inspection access.

Recently, the FDA has handed out inspection reports to 31 different compounders, and a variety of recalls have been issued.  Some lawmakers believe this shows the FDA already has the power to police the compounders.

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