Gottlieb Slams Manufacturers of Insulin

FDA commissioner says new rules coming in 2020 will spur more competition and put a stop to skyrocketing prices.

One of the reasons the price for insulin has risen so dramatically in recent years, some experts claim, is because three companies—Eli Lilly, Novo Nordisk, and Sanofi Aventis—control 90% of the insulin market. FDA Commissioner Scott Gottlieb couldn’t agree more. He announced this week that the FDA will roll out new guidelines that will spur more competition and reduce prices, but not until 2020.   

Pharma companies charge $1,251 per patient per year in the U.S. for insulin, and they’re able to do so because of a lack of competition, according to a study earlier this year by BMJ Global Health. In a more competitive market, it would be possible for drug makers to produce human insulin at $48 to $71 a year per patient, and analog insulins at $78 to $133 per year per patient.

Speaking this week at a FDA/CMS summit, Gottlieb said that this has become a life-or-death situation for some patients. “We’ve heard frequent reports of patients rationing insulin, and in some cases dying because they can’t afford the injections they need to survive. These tragic stories aren’t isolated occurrences. And they’re not acceptable for a drug that’s nearly a century old.”

Insulins are biologics, but because they’ve been around for nearly 100 years, they are not regulated the same way that biologics are regulated. The same goes for generic insulins. That will change in 2020, when insulin products will not be eligible for a 12-year exclusivity period now afforded biologics.

Gottlieb hopes that the change will allow biosimilar insulins to enter the market and increase competition, thereby driving down prices.