Regulator firing adds to reasons for FDA to take on compounders
The discovery that the top pharmacy regulator in Massachusetts sat on an initial complaint of problems at the compounding pharmacy at the center of a national outbreak of fungal meningitis will add fuel to the fire that the FDA should be watching over large-scale compounders.
James Coffey, director of the state's pharmacy board, got the ax Wednesday after state health officials uncovered the fact that he had not investigated a complaint he received July 26 about New England Compounding Center (NECC), Fox News reports. Counsel for the board, Susan Manning, was placed on administrative leave. Colorado regulators in July, months before the outbreak, complained to the Massachusetts board that NECC appeared to be violating its license by distributing drugs there. The Massachusetts board didn't bother to look into the complaint.
Steroids injected into patients in 19 states have been found to be contaminated and led to infections that have sickened more than 400 and killed 31, figures that rise daily. The fact that NECC was operating on a much larger scale than most compounders has led to two congressional investigations and suggestions that the FDA assume oversight over some of them. FDA Commissioner Margaret Hamburg is slated to testify before both House and Senate committees next week on the matter. In a statement to Reuters recently, she said the FDA is committed to working with Congress to realize "the authority we need to help prevent tragedies like this from happening again."
Compounders are traditionally monitored by state regulators. Efforts over a decade by the FDA to get some authority were litigated by the industry and fell before a Supreme Court decision. FDA inspectors had actually been in the NECC plant in 2006 to check a specific complaint and issued a warning letter noting sterility concerns but did not follow up until the outbreak. Recent inspections by the FDA and state inspectors have found filthy conditions and discovered that NECC shipped out some batches of the now suspect product before getting back from a lab the results of sterility tests.
- here's the Fox News story
Hamburg, FDA inspection practices go under microscope in meningitis outbreak
Report: NECC operated on manufacturing scale, failed in quality
Congressional committee wants answers on NECC's scale
Compounder tied to meningitis deaths sold large quantities
Should FDA get more power over compounding pharmacies?