Troubled Compounders: What FDA Knew And When It Knew
After months of anticipation, a House committee is holding a hearing today to review a scathing report about the extent to which the FDA knew about the manufacturing issues at the New England Compounding Center, which was tied to a nationwide outbreak of fungal meningitis, and a related compounding pharmacy called Ameridose. Since the outbreak, more than 700 cases have been reported, including 53 deaths, in what has been described as the worst public health crisis in the US in decades.
For the past few months, the FDA has skirmished with the House Energy and Commerce Committee over its legal authority to sufficiently regulate compounders, given a pair of confusing US Supreme Court rulings and a patchwork of state regulations. FDA commish Margaret Hamburg, in fact, is testifying again to defend agency actions (WATCH HERE). Just the same, the committee and a growing chorus of consumer watchdogs says the FDA has had authority to regulate compounders that act more like big drugmakers by producing large quanitities of medicines without individual patient prescriptions and shipping across state lines.
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