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Decorating The 'Christmas Tree’: US House Bills That Could Be Tacked Onto FDA User Fee Legislation

 
• By Sue Sutter

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.

Christmas tree ornaments
Like ornaments on the yuletide evergreen, lawmakers are eager to attach their bills to legislation reauthorizing the FDA's user fee programs. • Source: Alamy

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.

The current prescription drug, generic drug and biosimilar user fee programs expire on 30 September, and lawmakers are actively jockeying...

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