Some generics are approved but not sold

by jerry on February 10, 2019
Kaiser Health News published an article delving into why more approved generics are not making their way to the marketplace. In theory, streamlining FDA approval for generic drugs should mean more competition on the market, leading to reduced prices. However, the article points out that many approved generics are not even making it to the market, meaning that the emphasis on streamlining generics is not having the intended effect.

The article lists several reasons that manufacturers might not sell the generics after they get approval. One seemingly mundane reason is that approval can take six to eight years, by which time the manufacturers may have turned their attention elsewhere or the market conditions might have changed. Streamlining the approval process should help in this regard. Other reasons seem less innocent: some generics manufacturers are approved, receive exclusivity for six months, and then accept money from the competing name-brand manufacturer to not sell. This practice seems anti-competitive, and the head of FDA has expressed hope that Congress can change the laws so that such companies forfeit their exclusivity if they do not actually sell the generics. It is apparent that there are other factors in play as well; approving generics is only one step.