What does “drug safety” mean? All drugs have benefits as well as risks – and that’s why we have, for example, REMS and early safety signal communications (worts and all) as well as the FDA’s “safe use” initiative (wherein a drug is made safer when it is used as intended).
But the unsung hero of “safety” is “quality.”
I recently was invited to visit Pfizer’s Kalamazoo production facility. I expected “yawn” – but what I got was “gee!" -- as in GMPs.
What impressed me more than the gee-whiz production aspects of the facility (of which there were plenty) was the dedication of the people who work there – top to bottom. It actually reminded me a lot of the FDA. Long-term employees dedicated to serving the public health through dedication to quality. And they all took it very personally. Just like at the FDA, the Pfizer folks (many of whom were not only Upjohn legacy employees – but the sons and daughters of Upjohn employees) were on personal missions of quality. There was a lot of pride on display.
It was all about quality 100 ways to Sunday. And innovation.
But innovation with a twist.
The Kalamazoo facility makes (among other things) the API for methyl prednisolone, a corticosteroid long off patent. In fact, it’s been around for about 50 years. To my surprise, the Kalamazoo plant exports the API to both China and India.
A US manufacturing facility of an innovator biopharmaceutical company exporting API to China and India for profit? What’s wrong with this picture?
Well, as it turns out, it’s what’s right – innovation through manufacturing prowess, organic chemistry smarts and green technology. Better. Faster. Cheaper.
And also safer – since Pfizer’s figured out how to manufacturer it without preservatives.
Obvious implications for generic manufacturing standards as well as FOBs.
Pharma’s always bragging on its ever-growing investment in R&D. But when’s the last time you heard about investments in domestic manufacturing? Probably never. And when’s the last time you read about enhanced drug safety through cGMPs and cooperation between industry and the FDA? Not recently. That’s a shame because they’re two important stories.
Sound like an infomercial? Request a plant tour and see for yourself.
For more details on the Kalamazoo facility, see here.
