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.
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
"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 o 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."
For more information on the biotechnology industry, please visit www.bio.org.
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.
Upcoming BIO Events
CEO & Investor ConferenceFebruary 10-11, 2014New
Asia International ConferenceApril 8-9, 2014Tokyo, Japan
Congress on Industrial BiotechnologyMay 12-15, 2014Philadelphia,
International ConventionJune 23-26, 2014San Diego, CA
Biotech SummitSeptember 16-18, 2014Sioux Falls, SD
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