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“I certify that this compounded variation produces ‘a significant difference from the marketed drug version.’ “
If Congress’s initial, knee-jerk reaction to the 2012 New England Compounding Center (NECC) meningitis tragedy had become law, you would have had to add this federally mandated disclaimer to every prescription you wrote for a compounded drug. It seems Congress, influenced by pharmaceutical industry lobbying dollars, wanted to reward the FDA’s failure to shut down grossly negligent compounding manufacturers-but did so by granting the agency vast new powers.
Confused by this logic? Welcome to Washington, DC.
My organization, the Alliance for Natural Health USA (ANH-USA), and our allies eventually defeated the practitioner certification provision. However, it was just another twist in the long, sordid tale of the 2013 Drug Quality and Security Act-legislation that will forever change consumer and practitioner access to compounded medications.
Act I: Documented FDA Inaction Leads to Fifty-three Deaths
In 2002, the FDA began investigating Massachusetts’ NECC after receiving reports that five patients had become ill after receiving its drugs. However, the agency simply gave up its investigation after the NECC’s owner refused to cooperate. Just a few months later, two patients exhibited symptoms of bacterial meningitis after receiving NECC injections.
In 2003, FDA officials suggested the NECC be “prohibited from manufacturing” until it improved its quality and safety controls, as there was very real “potential for serious public consequences.” However, the FDA deferred any real action to the state of Massachusetts.
The FDA inspected the NECC in 2004. Two years later, it issued a warning letter based on violations it found during its inspection. In 2008, FDA received a complaint from its Los Angeles District Office about problems with NECC products. Separately, a New England-based FDA official recommended that the FDA inspect NECC. FDA declined, and instead sent another warning letter.