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Ready for FDA regulation of compounding pharmacies

Posted Oct 09 2012 5:02pm

The fungal meningitis outbreak caused by contaminated spinal steroid medications produced by the New England Compounding Center (NECC) has killed at least 11 people. More than 10,000 have received these injections; some patients are still at risk of developing meningitis. Naturally, this has sparked scrutiny of compounding pharmacies and calls for greater regulation. Add me to the list of people calling for more FDA involvement.

I’ve always been nervous about compounding pharmacies due to their lack of oversight and potential for errors and contamination. I have family members that rely on compounded products and I always worry when I pick something up. The larger facilities like NECC have a lot more in common with pharmaceutical manufacturing plants than your corner mom and pop drug store. Consider, for example, that NECC sent this particular product to 75 facilities in 23 states between July and December. Yet no FDA inspectors ever visit the facility. I’ve seen pharmaceutical manufacturing up close and it’s no place for self-regulation.

I spoke with Erik Gordon , professor at the University of Michigan’s schools of law and business and asked about the practicality and advisability of bringing in the FDA.

“It’s actually easy to get the situation under control,”  Gordon said. “You just need the political will to make compounding pharmacies subject to the same rules as any pharmaceutical manufacturing facility and empower the FDA to exempt classes of compounding pharmacies from the rule. FDA would immediately exempt most compounding pharmacies except for the large industrial ones, which is where most of the danger is.”

“It makes no sense for people who are essentially running a manufacturing plant to be able to escape FDA rules because they’re a compounding pharmacy,” he added.

Gordon told me that the scientific and manufacturing expertise needed to oversee compounding pharmacies does not vary from state to state and that there are not important local differences to take into account. Additionally, states are not well positioned to develop and apply this kind of expertise nor to share what they learn with other states.

“Even if you believe that in nine case out of 10 the states have the local knowledge and should be the regulators, this is the one case where that doesn’t hold,” Gordon said.


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