Thu November 21, 2013
Congress Passes Bill That Could Help With Drug Shortages
Last spring we reported on a serious problem in hospitals – shortages of critical drugs, including chemotherapy treatments, anesthetics and even basic vitamins. This week Congress passed a bill that could make it easier for hospitals to get drugs they can't find anywhere else. But there are also risks that come with this particular solution.
This bill is specifically about compounding pharmacies. Remind us what those are and why they're important?
Traditionally, a compounding pharmacy has been a place where pharmacists mix drugs for specific patients in their community – mom-and-pop stuff. But some compounders have grown way beyond that, and now produce drugs in bulk and ship them across the country.
How much is that growth tied to drug shortages?
That's a huge part of it. Hospitals have started relying on compounders as a sort of last resort. The head pharmacists for Carolinas HealthCare System, for example, say that compounders play a critical role.
But as compounders have grown, the regulations governing them haven't changed. That's led to confusing situations where FDA inspectors show up at a compounding pharmacy and effectively shut it down, while the compounder is like, what are they even doing here – I'm not regulated by them, and I'm not subject to the standards they're telling me I don't meet.
So why are FDA inspectors showing up?
Because of a deadly meningitis outbreak tied to a compounder. About a year ago, New England Compounding Center shipped tainted injections across the country. More than 60 people died, including one person in North Carolina.
How does the bill that passed this week address all this?
It tries to get rid of the legal gray zone that exists right now. It creates a new legal category for compounders mixing drugs in bulk. They'd be called "outsourcing facilities." And those facilities would have the option of registering with the FDA and coming under its authority.
Wait, the option?
Yep, it would be optional. For compounders who've undergone FDA inspections and are trying to figure out a way to comply, it's a no-brainer. We've reported on one of those compounders, Medi-Fare Drug Center. It's in South Carolina, about an hour from Charlotte. And here's what owner Pat Stephens says the bill means for her.
"It will allow me to get back to doing what we did before we were shut down," which is compound drugs in short supply for about two dozen hospitals in the Carolinas, she said. So she and those hospitals come away from this happy.
But what happens to compounders that choose not to register with the FDA?
It's not clear, but it looks like they'll be in the same gray zone that exists right now. Based on how we've seen that play out over the past year, some would probably keep compounding, others would shut down – and you can bet the FDA would be involved in some of those decisions.