As more patients in Maryland, Virginia and seven other states are found with severe meningitis infections from an injected steroid pain drug, the tradeoff in how the drug got made is becoming increasingly plain. It’s a new variation on the old line, “Your money or your life.”
The “compounding” pharmacy in Massachusetts that made and distributed 17,000 vials of the drug, contaminated with a fungus, was subject only to the loosest regulations. That kept down their costs and attracted hospitals and pharmacies as customers.
As one law professor, Kevin Outterson of Boston University. told the New York TImes: “The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts.”
According to Professor Outterson, “compounding” falls in a regulatory no man’s land. As he told the Times:
The F.D.A. regulates manufacturers, but compounders register as pharmacies, putting them under a patchwork of state rules. The F.D.A. did develop a clear set of rules for compounding, but subsequent litigation that culminated in a Supreme Court decision in 2002 struck them down, and Congress never re-established the agency’s clear authority.
Another law expert quoted by the Times asserted that the FDA could pursue these mini-manufacturers like the New England Compounding Center by contending in court that they were introducing unapproved drugs into interstate commerce.
But while legal authorities are poring over their books figuring out who’s in charge, doctors in pain clinics are taking a new hard look at where they buy their drugs from, and whether a bit of cost savings is worth the price in human lives at risk.