BIO Lauds House and Senate for 2014 omnibus spending agreement.
Press Release Summary:
January 21, 2014 - BIO applauded House and Senate appropriators for agreeing upon fiscal year 2014 omnibus spending package, which includes provisions for allowing FDA to access $85 million in user fees sequestered in 2013. In urging House and Senate to approve this package as soon as possible, BIO's Jim Greenwood said "It makes no sense to subject private company-paid user fees to sequestration." BIO also expressed support for overall funding for FDA, NIH, biodefense, and oversight of 340B program.
Biotechnology Industry Organization
Original Press Release
BIO Lauds House and Senate Omnibus Spending Agreement
Press release date: January 14, 2014
Spending plan would enable the FDA to access $85 million in sequestered user fees
WASHINGTON--The Biotechnology Industry Organization (BIO) today applauds House and Senate appropriators for reaching agreement on an omnibus spending package for fiscal 2014, which would, among other things, allow the Food and Drug Administration (FDA) to access $85 million in user fees sequestered in 2013. BIO urges the House and the Senate to approve this package as quickly as possible.
“It makes no sense to subject private company-paid user fees to sequestration. Having privately-paid user fees subjected to sequestration does not lower our nation's deficit.”
In addition, BIO expresses support for the agreement’s overall funding for: FDA, NIH, the biodefense enterprise; and improved program oversight of the important 340B program. BIO also strongly supports the language in the bill providing the Department of Energy transfer authority to the Defense Production Act program for the development of cleaner drop-in aviation and marine biofuels.
The absence of funding in the bill for vital Farm Bill energy programs emphasizes the need to get a Farm Bill completed with mandatory funding levels for energy title programs. The Farm Bill would give these programs funding in the immediate term and would ensure funding of the programs into the future.
The following statement can be attributed to BIO President and CEO, Jim Greenwood:
“Through this agreement, the House and Senate recognize the importance of restoring FDA access to the portion of user fees denied them under sequester. Unfortunately, the sequester restricted FDA’s ability to access the full amount of all of their user fees, including the user fees our companies pay to provide resources for expeditious review of new drug applications.
“User fees represent no cost to American taxpayers, while benefiting patients and caregivers immensely through timely availability of safe and effective treatments.
“It makes no sense to subject private company-paid user fees to sequestration. Having privately-paid user fees subjected to sequestration does not lower our nation's deficit.
“Instead, the only real effect is that FDA has not been able to access all PDUFA user fees, thus inhibiting the ability of the Agency to fulfill its mission of ensuring patient access to safe, effective new drugs and biologics.
“We firmly believe that freeing the user fees so that FDA can fully access them will greatly benefit public health.”
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BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter.” Subscribe to the BIO Newsletter.
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