Once again, the FDA is at loggerheads with a compounding pharmacy and the latest case underscores the difficulties the agency can sometimes encounter when trying to oversee a compounder that refuses to comply with enforcement steps.
Late last week, the FDA late last week took the unusual step of issuing a reminder to healthcare providers not to administer any sterile drugs made and distributed by NuVision Pharmacy. The agency issued a similar alert this past May and last month, sent a letterto the Dallas compounder requesting an immediate recall of all sterile products.
However, the compounder responded by issuing a statement on its web site maintaining that it does not qualify as a drug manufacturer and “current state laws do not require compounding pharmacies to follow (FDA) standards for manufacturing.” And NuVision added that it is not issuing a recall for all products, and the FDA maintains it cannot require the compounder to do so.
Last April, the agency issued an alert to healthcare providers, hospitals and pharmacies over concerns that freeze-dried powder drugs held a “high potential” for contamination based on an ongoing inspection. At the time, NuVision agreed to recall those particular products, but in its July 26 letter, the FDA notes that NuVision failed to address sterility problems seen during an inspection last March (here is the report).
The FDA is likely to point to this battle as an example of why Congress needs to pass legislation that would clarify and enhance its authority over compounders. The issue arose in the wake of an outbreak of fungal meningitis traced to the New England Compounding Center in which 749 cases, including 63 deaths, have been reported in nearly two dozen states (see this).
The episode has cast a harsh spotlight on the FDA and state regulators, and the extent to which they properly exercise their available authority. There has been considerable debate over this point, especially since FDA officials earlier this year acknowledged that more could have been done to oversee compounders (see this).
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