US Senate Committee on Health, Education, Labor, & Pensions

Bipartisan FDA User Fee Reauthorization Is Good Starting Point

Wednesday, April 25, 2012

WASHINGTON, D.C. –  Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Tom Harkin (D-Iowa) and Ranking  Member Senator Mike Enzi (R-Wyo.) today said the Committee’s markup of FDA user fee reauthorization reflected a strong  bipartisan effort. 

“Today’s markup of the user fee agreement reauthorizations was an important step,” said Harkin and Enzi.  “At a time when Congress has been deeply divided, today’s markup displayed strong bipartisan cooperation.”

Harkin and Enzi noted that this legislation builds upon the current user fee programs, which will expire in September.  If new drug and medical device user fee agreements are not authorized before current ones expire, FDA must lay off nearly 2,000 employees.  This would derail the premarket review programs, threatening patient access to new therapies, biomedical industry jobs, and America’s global leadership in biomedical innovation.  

“In addition to user fees, this bill will reauthorize programs that have helped make medicines safer for millions of children, upgrade FDA’s tools to police the global drug supply chain and ensure that American patients get better access to safe, innovative medical devices and medicines,” said Harkin and Enzi. “This measure will also help reduce the risk of drug shortages.”

# # #

More Press from the Chairman