Inside its sprawling red brick offices, New England Compounding Center engaged in the most hazardous type of pharmacy drug making. The company bought unsterilized powders and turned them into liquid steroids and other medicine supposedly pristine enough to inject into a patient.
It’s called “high-risk compounding,” and doing this safely, industry specialists say, requires elaborate and expensive manufacturing processes, sensitive tests for sterility and potency, and exacting attention to detail.
Comments
We certainly hope that all those Liberetards who keep whining about too much gummint regerlation have been following this story.
Ms. Kowalczyk provided useful background on the growing business of drug compounding here, following up on her less useful article of October 5 without falling this time for decoys being launched by government agencies trying to obscure shortcomings.
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The state's health department tried to claim NECC in Framingham was operating "illegally" but could not cite any clearly relevant law or regulation, mainly because the state has only addressed "controlled substances" in some detail, mostly ignoring ordinary prescription drugs.
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FDA tried to claim they lacked authority over compounders, based on a 2002 Supreme Court case. [Thompson v. Western States Medical Center, 535 U.S. 357, 2001] However, FDA has since asserted its authority when compounders produce a new drug and when they adulterate or misbrand a drug. NECC clearly adulterated drugs by contaminating them with fungus, but FDA had not regularly inspected NECC.
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It would be helpful to look into why hospitals, among others, have been buying from compounders. Sabrina Tavernise and Andrew Pollack made a start at that, reporting October 27 in the NY Times that Brigham & Women's has bought drugs from NECC for several years but is now compounding them in-house. Does that make hospital patients any safer?