Quality Executive Partners (QxP) attended the AAM/IGBA meeting in Orlando, Florida in February. The event was simultaneously informative, thought-provoking, and challenging. The audience listened to industry experts describe the roadblocks that the generics industry faces (particularly in the U.S.) and it gave everyone a reason to pause, consider the problems, and try to find ways to reach common ground.
Given the complexities involved in the processes of bringing these life savings drugs to American patients and current market dynamics, it’s no wonder that cost to manufacture has become a race to the bottom for the generics industry.
The pharmacy benefits managers (PBMs), insurance companies, and distribution lanes add costs to these medicines. And though the generics industry is essentially pricing at cents per pill, the American patient still pays too much for the medicines they need and without transparency as to why. This, in turn, causes the generics industry to race to the bottom to charge even less per pill so that their products can be written into formularies and be accessible in our country.
We are approaching a significant problem in our healthcare system. U.S. cost structures do not incentivize generics manufacturers to sell here and in turn, exacerbate access problems to these medicines that are desperately needed to treat the American patient. This is a significant risk to the supply chain of medicines for our country.
As I reflect on the sessions, including Mark Cuban’s fireside chat on his Cost Plus Drug Company, and many SVPs and CEOs of large generic manufacturers like Teva, Sandoz, Amneal and Dr. Reddy, the one topic that was not mentioned explicitly was quality.
Quality is essential in the algorithm of cost and more importantly, the value that generic drugs deliver. When you don’t include quality in the equation, the American patient assumes that they are getting medicines from their pharmacy that are as labeled:
- The medicine is pure (free of impurities)
- The medicine is at the strength prescribed and needed
- The medicine is effective.
I contend that quality means doing things right the first time:
- There are no compromised shortcuts
- There is efficiency in manufacturing
- There exists no repeating steps or reworking of product (all of which increase time and money to make)
We have started to witness significant U.S. regulatory action at foreign manufacturing sites due to a general lack of quality in manufacturing practices. Issues exist around data integrity, cleaning procedures/validation, hold times, and stability. The ability to get your product into US commerce is getting harder, as the race to the bottom is reinforced. This is yet another issue to consider when discussing the challenges of the U.S. supply chain of generic medicines.
We all know the saying, “If you do not have time and money to do it right the first time, you will always find time to do it again the right way”. If you, as the head of a global generics manufacturer, need or want to take a step back and have your manufacturing system evaluated for quality and efficiency, please reach out, I would love to have a discussion.
A discussion that centers on quality will not solve everything in this industry, but it is a step forward and one all companies should take. Paraphrasing a dynamic leader and speaker at the conference, Cynthia Meiners, SVP Strategic Program Development Officer at Good Rx: “Ensuring public health by strengthening the medicine supply chain is one of the single most important and personal needs we have.”
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QxP Vice President Christine Feaster is a 20+ year veteran in pharma quality assurance. Prior to joining QxP, Christine was a vice president of U.S. Pharmacopeia.
