Echoes Call for Increased Public Support
WASHINGTON, Sept. 25 /PRNewswire/ -- Jim Greenwood, president and CEO
of the Biotechnology Industry Organization (BIO), today joined a
distinguished and diverse group of former government officials and
representatives of patient groups, consumer advocacy organizations and
industry associations to announce the formation of the Coalition for a
Stronger FDA.
"BIO is proud to join this broad, diverse coalition," said Greenwood.
"Our members overwhelmingly support the group's goal: To ensure a strong
and consistent public commitment to resources for the FDA in order for the
agency to fulfill its mission of guaranteeing the safety, efficacy and
security of the products it regulates."
Greenwood commented that while the FDA continues to set the global
"gold standard" for regulatory science and consumer protection, it has been
forced to address an ever-increasing array of issues and revolutionary food
and medical advancements with tightening resources.
"While there have been increases in public funds for the FDA, the
agency's funding has not kept pace with its growing responsibilities. In
recent years, the FDA's responsibilities have expanded to include more
counterterrorism activities, pandemic disease preparation, food safety
activities, and more. The FDA's total appropriations are currently less
than the agency's actual cost of doing business," Greenwood noted.
Greenwood added that the biotechnology industry is particularly
concerned about the agency's increasing reliance on user fees to help make
up for federal appropriations challenges.
"User fees now account for more than 59 percent of funding for FDA's
human drug review -- or a 700 percent increase since 1993 when the
Prescription Drug User Fee program was implemented," Greenwood stated. "If
this high rate of corporate funding continues, it will undermine public
confidence in FDA's independence. While user fees play a key role in
providing multi-year predictability and stability for the FDA, they were
never intended to replace annual federal appropriations."
In closing, Greenwood emphasized the importance of the Coalition's
goal.
"Securing adequate support for the FDA in the coming years is
particularly important as the agency prepares to address the coming wave of
exciting new biomedical advances," he stated. "Without appropriate
resources at the FDA, new therapies for major diseases could be seriously
slowed if the agency were to become a bottleneck for the approval of new
products. Companies could face increased difficulty obtaining funding for
innovative research and development without a clear review and approval
timeline, jeopardizing U.S. leadership. Consumer confidence in food and
drug safety will erode."
"By working together with the other members of this effort, we hope to
bring about greater public confidence in the FDA's ability to make
independent, scientifically and medically appropriate regulatory decisions
on the safety and effectiveness of new food and medical products," said
Greenwood. "At the same time, we can help ensure improved patient access to
novel therapies. In the end, this effort can be a win-win for consumers,
for the FDA and for the industries it regulates."
BIO represents more than 1,100 biotechnology companies, academic
institutions, state biotechnology centers and related organizations across
the United States and 31 other nations. BIO members are involved in the
research and development of healthcare, agricultural, industrial and
environmental biotechnology products. http://www.bio.org
SOURCE Biotechnology Industry Organization
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Related links:
http://www.bio.org
CONTACT:
Kim Coghill, +1-202-962-9232, or Jeff Joseph,
+1-202-962-9230, both of Biotechnology Industry Organization
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