As the story of the Framingham-based “compounding pharmacy” continues to unfold, it’s absolutely clear that there is a giant loophole in regulating these sorts of businesses.
That’s something Congress must fix.
At this point, the outbreak of fungal meningitis has killed more than a dozen people and sickened more than 170 — and health officials continue to find more people infected. The outbreak has been traced to the New England Compounding Center and its handling of an injectable steroid that was shipped to different parts of the nation — at least 23 states — and to have been administered to upwards of 14,000 patients in the treatment of neck and back pain.
As it turns out, these sorts of drug producers don’t come under the purview of the U.S. Food and Drug Administration and therefore aren’t subject to the same rigorous testing, inspections and standards established for regular pharmacies. Instead, state pharmacy boards are supposed to be the watchdogs.
This arrangement may have been OK back in 1997 when the Food and Drug Administration Modernization Act was enacted and these compounding pharmacies were small operations, in the business of producing drugs that were “customized” for individual patients. But some 15 years later, the industry has changed, with many of these firms expanding to compete with the more traditional pharmacies.
Yet regulations have not kept pace with their growth. That’s not to say warning flags about possible dangers haven’t been raised. But the courts and Congress have, up until this outbreak, treated compound pharmacies with kid gloves.
This tragedy should get our lawmakers to realize that the times and industry have changed. The FDA is in a much better position than the individual states to police this industry.
To continue with the status quo is just inviting a repeat of tainted medicine finding its way to patients.