National Consumers League

Greenberg comments on Biosimilar User Fee Act (BsUFA II)


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October 20, 2016

Contact: NCL Communications, Cindy Hoang, cindyh@nclnet.org, (202) 207-2832

Washington, DC–The National Consumers League (NCL) appreciates the opportunity to deliver these comments on the reauthorization of the Biosimilar User Fee Act for fiscal years 2018 through 2022 (BsUFA II). The National Consumers League has long been concerned with ensuring the safety of foods and drugs. Among NCL’s top priorities are ensuring the safety, effectiveness, and appropriate use of both prescription and over-the-counter (OTC) drugs, and medication adherence, which we have helped to advance through our Script Your Future Campaign.

The National Consumers League is a strong supporter of biosimilars, since they help to provide less expensive biological products for patients with serious diseases, such as rheumatoid arthritis, multiple sclerosis, and cancer. Since 2012, BsUFA has helped to provide FDA with the resources the agency needs to enhance the science-based review of new biosimilars. User fees are integral to the FDA’s ability to review drugs and biologics in a timely manner, since the agency is woefully underfunded. To make matters worse, due to a .5% Across-the-Board (ATB) cut included in the Continuing Resolution, the FDA will experience a $2.5 million cut in funding over the 10-week period until December 9. It is clear that user fees are necessary for the FDA to carry out its drug and biologic review functions.      

Click here to read the full statement.

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About the National Consumers League

The National Consumers League, founded in 1899, is America's pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.