After reading all the finger pointing, let's look at who is ultimately at fault for poor launches across pharma... The FDA. Compare the information that was included in Basal Insulin Labels from the early to mid 2000's to now. Comparative PK/PD graphs. Do we have one for our latest glargine product? Nope. Does Novo have one for their new basal? Nope. We used to have secondary endpoint data included in labels. Do you see anything stating the hypoglycemic benefit of either of the two latest basal insulins in their labels? Nope. The data is out there, it's been proven time and time again between the two latest entrants into the market. Why won't the FDA allow either of us to put that information out there? Why?
Simple. Follow on Biologics. Glargine U-100 will be made by many companies. It is a good insulin, the FDA knows that for many it is "good enough," and CMS, the largest payor for said insulin, will see the price of glargine come down, thus saving them millions if not billions annually. Clinical studies show that there may be a better option for many patients. But that data is suppressed not in the name of pharmaceutical innovation and advancement, but rather in the name of dollars and cents.
So the next time you think about how bad a marketing piece is, look at the label they have to work with. And the next time the sales force is underperforming expectations... Look at the data we are allowed to work with.
BTW, this administration wants to limit Biologic patent exclusivity to 7 years down from the current 12. What do you think is happening here?
Follow the money.
Simple. Follow on Biologics. Glargine U-100 will be made by many companies. It is a good insulin, the FDA knows that for many it is "good enough," and CMS, the largest payor for said insulin, will see the price of glargine come down, thus saving them millions if not billions annually. Clinical studies show that there may be a better option for many patients. But that data is suppressed not in the name of pharmaceutical innovation and advancement, but rather in the name of dollars and cents.
So the next time you think about how bad a marketing piece is, look at the label they have to work with. And the next time the sales force is underperforming expectations... Look at the data we are allowed to work with.
BTW, this administration wants to limit Biologic patent exclusivity to 7 years down from the current 12. What do you think is happening here?
Follow the money.