The FDA has an ally in its effort to get hospitals to buy compounded drugs from only those companies that volunteer to be regulated under a new FDA program. It is one with substantial reach. While healthcare improvement company Premier is not generally one to look favorably on federal regulation that affects its 2,900 member hospitals, it is urging its clients to get on board with this one.
That's because a lot of risk has grown up around buying compounded drugs, "and the risk is with the hospitals," said Blair Childs, senior vice president with Premier. "Those hospitals in Kentucky and Tennessee that bought drugs from NECC are being sued," Childs said during an interview in San Francisco where he was attending the J. P. Morgan Healthcare Conference at which Premier CEO Susan DeVore presented.
The NECC he referred to is the New England Compounding Center, the now defunct compounding pharmacy whose ostensibly sterile drugs were tied to a fungal meningitis outbreak that infected more than 750 patients, 64 fatally. In response to the outbreak, Congress last fall passed the Drug Quality and Security Act. Instead of giving the FDA absolute authority over the largest compounders as it sought, Congress crafted a law creating a voluntary program with the idea that hospitals would want to buy from regulated companies with an FDA seal of approval. FDA Commissioner Margaret Hamburg sent letters to hundreds of facilities last week asking them to do just that.
So far, only 11 of the roughly 3,000 compounding pharmacies that make sterile injectable drugs have signed up for the voluntary program.
While Premier, which negotiaties drug contracts for its members, does not source compounded products for them, Childs said that it did inspect some compounders on their behalf. Having taken a look at the manufacturing conditions at some of the large operators, Premier waved members off from using many of this new breed of large-scale compounding operations. They suggested they use "sterile to sterile" repackagers instead. But with the new FDA program, Blair said Premier is encouraging members to buy from those compounders getting FDA oversight. "And we think the market will respond."
- here's the FDA list of registered compounders