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States Take On Unregulated Pharmaceutical Facilities As House GOP Holds Back Nationwide Reform

By Sy Mukherjee  

"States Take On Unregulated Pharmaceutical Facilities As House GOP Holds Back Nationwide Reform"

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(Credit: ABC News)

After last year’s deadly meningitis outbreak was traced to unclean conditions at a New England-area pharmaceutical mixing plant, state and federal officials called for increased oversight of the largely unregulated facilities. But as states await congressional action to give the Food and Drug Administration (FDA) and state agencies more regulatory authority over the so-called “compounders,” many have taken it upon themselves to increase facility inspections in an effort to protect public health.

Since December’s outbreak, five states — including Maryland and Virginia, which experienced fatalities linked to the incident — have already passed new laws strengthening regulation of compounding pharmacies, and another nine have legislation pending. Independent groups have also conducted over 100 inspections in several other states.

But as Politico reports, barring enhanced funding and clearer lines of FDA and state authority endorsed by Congress, there is only so much that states can do on their own:

“NECC just blew this out of the water, and there was a recognition that these guys really weren’t being overseen much at all,” said Joseph Hill, legislative director for the American Society of Health-System Pharmacists. “States realized they need to know who these compounders are, where they are operating and where they are sending product, and to provide some oversight.” [...]

Many states have been devoting the resources needed in the short term to bolster inspections, Catizone said, as they wait to see what Congress will do before passing laws of their own.

But even as states act, the steps they are taking vary. And experts say it would be difficult for them to plug the regulatory hole on their own.

“It’s partly a matter of resources,” Hill said. “You can have the perfect regulation, but if you can’t spend the time and money to give your people specialized training and send them to do inspections, the regulation won’t matter much.”

Those additional resources are particularly significant considering that inspections conducted since the outbreak have revealed that a vast number of compounding facilities violate safety guidelines, including unsanitary conditions such as rusty and moldy mixing plants.

Congressional Democrats have introduced bills that would crack down on compounders by increasing FDA funding, creating a federal database of compounding facilities, and subjecting the drug makers to a minimum level of production standards. But House Republicans have been skeptical about requests for additional resources and tighter regulations, arguing that the FDA’s past failure to prevent outbreaks such as last December’s indicates that such legislative measures would be futile. FDA director Margaret Hamburg has argued that the exact opposite is true, and that barring legislative fixes, the agency will be largely unprepared to address future crises — as will the states that have taken it on themselves to safeguard their residents’ public health.

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