Action on Beacon Hill to tighten oversight of compounding pharmacies is a good (if overdue) development. But as always with these matters the scrutiny of the specialty pharmacies will only be as strong as those doing the scrutinizing. A bill now on Gov. Deval Patrick’s desk is an improvement on the status quo, but we won’t be impressed until we see meaningful enforcement in action.
Nearly two years after a national fungal meningitis outbreak was traced to the New England Compounding Center in Framingham, the House and Senate last week finally approved a bill that will require the specialty drug dispensaries to secure a special state license and to undergo both annual and unannounced inspections. It carries new labeling requirements and improves patient access to information.
It will even require that inspectors undergo training specific to the type of specialty work these pharmacies handle. Imagine that — actual training!
Recall that an ugly round of finger-pointing followed the fatal meningitis outbreak, which was traced to tainted steroid injections and cost dozens of people their lives.
The Food and Drug Administration shifted blame for the crisis, pointing out that states are responsible for oversight of compounding pharmacies.
The hapless Department of Public Health had an inkling that NECC had strayed miles from its core work — to provide specialty drug mixtures for individuals with patient-specific prescriptions. But it didn’t act to rein it in. And the Board of Registration in Pharmacy, rife with conflicts, failed in its oversight role, too.
The bill changes the makeup of the pharmacy board, in addition to the new licensing and inspection rules. It is a necessary effort to force the executive branch to do the job it should have been doing all along.