Posted by Michael Wonder on 02 Apr 2019
Statement from FDA Commissioner on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access
2 April 2019 - Access to affordable insulin can be a matter of life and death for Americans with diabetes.
Insulin is a critical hormone that regulates sugar metabolism. The body’s inability to produce sufficient levels of natural insulin can lead to diabetes – both inherited Type 1 and Type 2, typically called adult onset. Diabetes affects nearly 30 million Americans and can lead to serious and life-threatening complications, including heart disease, organ failure and blindness.
Driving down drug prices requires a comprehensive approach. But one impactful route is through competition. This is particularly true following the introductions of generics, especially when there are three or more generic competitors – which has been shown to bring down prices more sharply than with only one or two generic competitors. A robust pathway for generic competition is critical to expanding drug access and promoting public health. The FDA has worked hard to encourage generic entry after patents and other exclusivities have lapsed. Ours is one of the most competitive generic markets in the world.
