"As we all start peeling back the layers of this onion, it turns out this has been an issue that any number of people have been quite aware of for some time," says Vanderbilt University Medical Center's William Schaffner, MD, past president of the National Foundation for Infectious Diseases. "It's just that nothing's been done about it. And it's not because harmful contamination issues have not occurred. They have."
Lawmakers and regulators, for whatever reasons, haven't wanted to tackle it, he says. Maybe it has been considered a state's rights issue, or maybe these compounding companies were seen as too small, or their operations too benign to cause much damage.
But here we have a major problem: Deaths and illness and panic in 10 states where 13,000 people have been exposed. Only now do the headlines say lawmakers are starting to take notice.
A patchwork of regulations
This scandal has exposed huge regulatory loopholes—a patchwork of widely varying state regulations, combined with unclear definitions for when a compounding pharmacy becomes a "manufacturer"—that have allowed these suppliers to escape U.S. Food and Drug Administration oversight.
Manufacturers do have to register with and meet requirements of the FDA, but compounding pharmacies do not, leaving unclear what propels a mere compounding pharmacy to manufacturer status.