Compounding problems

The FDA’s clearest authority to regulate compounding was struck down by a 2002 Supreme Court case, Thompson v. Western States. Struck down on First Amendment grounds. Congress held hearings in 2003, but no legislative fix emerged.

Now, almost a decade later, industrial scale compounding has led to contaminated injections, more than a hundred cases of fungal meningitis, and at least nine deaths.

As I said in the NYTs on Sunday:  “The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts.”

Additional interviews at PBS NewsHour Monday.

@koutterson

 

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