Diabetes Blogs

The FDA Finally Has a Plan to Reduce the Cost of Insulin

high cost of insulin, vials, syringe and calculatorIn a statement released in late December (2018) FDA Commissioner Scott Gottlieb, MD, vowed to do more to reduce the price of insulin. At long last, the government seems to finally be giving more than lip service to the serious issue of affordability to this life-saving product..

Did you hear the big news that came out this past week from the US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, that will affect people with diabetes? 

The FDA released a statement announcing forthcoming action that will assist with bringing down the price of insulin, starting in 2020 (when the changes would start). He spoke about working to open up competition amongst pharmaceutical companies. He stated, “not all parts of the pharmaceutical market have been equally open to competition from more affordable products. This is especially true for biological medicines, which are typically complex molecules produced by living cells, and are increasingly the backbone of modern therapy.” 

Have I lost you yet? I asked my father, my favorite pharmacist, to break down the press release from the FDA Commissioner for me, because there’s a lot of big words and drug classes, and let’s be honest, I just want to know if this means good things for people like me who are struggling to pay for insulin, or is this just more lip service? 

This is how he explained it to me last night….

Father Knows Best

“The big difference between insulin and regular name brand drugs is that technically insulin is defined as being a 'biological' product made within a complex biological system. For a regular drug, say Motrin, many manufacturers can copy it’s chemical or molecular identity. Ibuprofen is a molecular structure versus insulin which by FDA current 2018 standards is considered a biological entity," he explained and continued. 

"Because insulin has been considered a biological and not a drug by the FDA, it has been governed by different standards, making it tougher for other competitors to come into the market and for generic insulins to come as well. This includes how fast another company can copy their product.”

(In other words, pharmaceutical medications come from chemical processes; biologics, like insulin, involve animal, human or other forms of microorganism.) 

In essence, the Commissioner is relaxing the rules for biologicals (insulin), to make is easier for other companies to enter the market to allow for more competition. 

Ultimately, we need to bring in more companies that are willing to make insulin, because right now we have three companies who produce the majority of the insulin in the US. (Novo Nordisk, Eli Lilly & Sanofi). That’s part of the insulin pricing problem right now. They can price gouge because as customers we don’t have any choices but them! We need new companies to see what a large market we are, and that there is a market for low-price insulin.

There are days when I feel defeated as a diabetes advocate and that we have a long road ahead of us. But then there are days when I see a press release like this and my heart is filled with hope again know that an agency as powerful as the FDA cares, really and truly cares, about the 7,000,000+ people that depend on insulin in the US.

This acknowledgement conveys to me and many other people living with diabetes that they understand what a critical issue this has become. FDA Commissioner Gottlieb said in his statement, “Access to affordable insulin is literally a matter of life and death for these Americans.”

Thank you Commissioner for standing up and making a difference. 

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