National Consumers League

NCL to submit comments to FDA on Prescription Drug User Fee Act VI


August 15, 2016

Contact: Cindy Hoang, National Consumers League,, (202) 207-2832 

Washington, DC--Today the nation's pioneering consumer advocacy organization, the National Consumers League (NCL), will submit comments to the U.S. Food and Drug Administration on the reauthorization of the Prescription Drug User Fee Act for fiscal years 2018 through 2022 (PDUFA VI). Founded in 1899, 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 NCL has helped to advance through its Script Your Future Campaign.

"As PDUFA VI goes through the reauthorization process, NCL urges the FDA to remain mindful of the concerns expressed by some that because industry pays user fees, industry thereby controls the FDA’s agenda and process. It is critical for the agency to act independently of industry influence and to uphold its high standards for safety, efficacy, and quality of prescription drug products," said Karin Bolte, NCL director of health policy, who will deliver a statement and submit comments on behalf of NCL today. 

"NCL wants to be sure that in the quest to reduce barriers to new drug approvals, FDA does not lose sight of the importance of the agency’s mission of protecting and promoting the health of consumers and patients. The FDA must balance the needs of consumers who are concerned about serious side effects with the concerns of patients who may be facing a life-threatening illness where time is of the essence. However, even patients in great need may be harmed rather than helped by drugs that have been approved too quickly without adequate consideration of safety and effectiveness or toxic side effects."

NCL's full comments are available here.


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