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.