The US Food and Drug Administration’s human drug, biologic and medical device user fee programs require reauthorization every five years. Legislation to accomplish that task is often referred to as a “Christmas tree” because many other bills, or parts of bills, are tacked onto the must-pass measure, like ornaments placed on an evergreen during the holiday season.
Decorating The 'Christmas Tree’: US House Bills That Could Be Tacked Onto FDA User Fee Legislation
Measures aimed at spurring biomedical innovation, ensuring fewer roadblocks to development of biosimilars and generics, and strengthening the FDA’s interactions with rare disease patients could find their way into must-pass legislation reauthorizing the human drug and biologic user fee programs by 30 September.
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