Many Shades Of Evergreen: A Variety Of Legislative Approaches For Preventing The Practice

Executive Summary

The Hatch-Enzi-Hagan follow-on biologics amendment to the Senate HELP Committee's health care reform bill contains a provision not present in last year's consensus bill designed to prevent "evergreening," under which brand would be eligible for maximum exclusivity by making only minor changes to products. Evergreening concerns were the primary factor that had prevented reintroduction of last year's bill, and many subsequent pieces of legislation and amendments that attempted to address the issue specified a variety of specific structural elements - such as glycosylation - that would render a product ineligible for data exclusivity.