Food and Drug Administration Safety and Innovation Act
Floor Speech
BREAK IN TRANSCRIPT
Mr. BENNET. Mr. President, I come to the floor today to support the goal of my friend and colleague from New Mexico of delivering lower cost medicines to Americans. But, unfortunately, I cannot support his underlying amendment, No. 2111 to S. 3187. I agree that we should increase access to generic drugs wherever we can, and I agree that the path to market for generic products is fraught with legal challenges. But I have several concerns about the amendment. First, as convoluted as it seems, the Hatch-Waxman law that created the pathway to bring generic drugs to market has been a tremendous success in doing just that. Eighty percent of the drugs on the market now are generic, and over the last decade consumers have saved $931 billion on their drug costs as a result. There is clearly a balance in the system, and mechanisms within that system are working to bring generics to market.
As I understand it, a key element of generic entry into the market is the incentive to challenge brand-name patents. The underlying amendment changes the key incentive for generic manufacturers--the 180 days of market exclusivity. The amendment allows late filers to now share in the exclusivity, significantly reducing the incentive for companies to file early and ensuring that products get to market as quickly as possible. Generic manufacturers have a limited window for market advantage, and it is the revenues gained during this incentive period that fuel additional product development. There is a balance here. If we need to adjust that balance, I think it needs to be done in a broader context. We need to be sure that any changes that we might make do not disrupt the balance and inadvertently harm consumers.
While other aspects of the amendment are well-meaning, they may also have unintended consequences. I look forward to continuing the dialog on this issue with my colleague and others as we all work collectively to provide lower cost medicines to our constituents while maintaining an appropriate incentive for companies to innovate and develop the therapies that patients need.
BREAK IN TRANSCRIPT
Source