We all depend on pharmaceutical manufacturing to produce our prescription drugs that are consistent in formulation, safe, and not contaminated with foreign materials or potentially harmful pathogens.
Anybody who has done pharmaceutical manufacturing, especially biologics or sterile injectable prescription drugs, knows how challenging it is to repeatedly get it done right in large scale. From engineering and process controls to supply chain and inventory management to quality systems the expertise required to consistently produce high quality, regulatory compliant prescription drugs is perhaps one of the most unappreciated critical success factors for a pharmaceutical company. If you can’t make it you can’t sell it.
This expertise is a core competency that has clearly been taken for granted by Big Pharma senior executives. This lack of appreciation for manufacturing expertise is evident every time a pharmaceutical company faces a recall or needs to shut down due to “quality issues.” Perhaps best exemplified by the now well publicized drug shortage situation, the inability to manufacture these life saving prescription drugs is putting patient lives at risk. The lack of appreciation for the complexities and challenges of pharmaceutical manufacturing manifests itself in these shortages.
So what does it take to do high quality, safe, and regulatory compliant prescription drug manufacturing? It takes a broad range of expertise (not just well trained technicians and operators), significant ongoing capital investment in facilities and equipment, and rigorous, almost obsessive quality systems. These are not the places pharmaceutical executives should be looking to cut costs. And worse, generic drug pricing generally don’t allow for the levels of continuous investments I believe are necessary in people (expertise), facilities, equipment, and quality systems.
But what about Big Pharma? Well, who had the expertise? Who had the robust quality systems? I’ll even add … who had the proprietary insight into the nuances and complexities of making a particular prescription drug. Big Pharma. At least they did until they decided to take manufacturing expertise for granted. Unfortunately, Big Pharma continues to close manufacturing facilities, outsource more to contract manufacturers, and retire or let go much of their manufacturing expertise. And, this expertise and know-how doesn’t necessarily get transferred from Big Pharma to the manufacturers that will be making the generic versions of their products.
I often wonder how generic drug manufacturers or even contract manufacturers who take over manufacturing a prescription drug figure out, understand, and know how to deal with all the nuances and complexities of making a particular prescription drug. Again, if you’ve done pharmaceutical manufacturing, you know how much is learned by doing hundreds and thousands of batches over years of experience. Perhaps those who are challenged with making the drugs that are now in shortage are finding this out the hard way. Unfortunately, it is patients who are now suffering and dying because pharmaceutical manufacturing is harder and takes more expertise than most pharmaceutical company executives appreciate. mike@pharmareform.com
