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.”
# # #
- Harkin, Miller, Warren, DeLauro Introduce Legislation to Establish Fair Work Scheduling Practices [Chairman]
- PHOTOS: At White House, Harkin Applauds Signing of Bipartisan Bill to Update America’s Job Training Programs [Chairman]
- Harkin: ACA Designed to Ensure Quality, Affordable Coverage Available to Every American [Chairman]
- Alexander on Federal Appeals Court Striking Down Obamacare Subsidies for Tennesseans, Americans in 36 States [Ranking Member]
- Harkin Applauds Committee Approval of CRPD, Urges Full Senate Consideration [Chairman]
- Statement of Senator Tom Harkin (D-IA) At the Employment and Workplace Safety Subcommittee Hearing: “Coal Miners’ Struggle for Justice: How Unethical Legal and Medical Practices Stack the Deck Against Black Lung Claimants” [Chairman]