"This pharmacy had been disciplined by the Massachusetts Board of Pharmacy. And in addition, the FDA has the statutory authority to inspect any pharmacy at any time," Miller says.
Except that in this case, the laws and regulations didn't work because apparently, the discipline didn't prevent this from happening,
In the time it took me to write this column, the death toll increased by from 11 to 12, the number of people infected from 119 to 137, and the number of people who may have been exposed is now at 13,000 in 10 states.
I note that in the 2002 MMWR report, federal disease investigators cautioned: "Some health system pharmacists might not realize that they are purchasing injectables prepared through compounding." The agency urged purchasers to check that "supplies are provided through a compounding pharmacy that is licensed in their state and that follows appropriate measures."
And there was this line: "In most states, compounding pharmacies are not required to report adverse events associated with their products to state or federal agencies," however, reporting to the FDA is required for "manufacturing companies."
Even though the unused steroid products are being recalled, it's obvious to me that the issue has legs this time, even if last time it was quickly forgotten. Lawmakers and regulators will have to step in. I think they should give the FDA authority to take a much greater role to prevent this from happening again.
Vanderbilt's Schaffner put it a different way: "I think we're going to have to rub the Congress's nose in this, because this is not the sort of thing it likes to get into."