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The U.S. Food and Drug Administration (FDA), part of the U.S.
Department of Health and Human Services, is requesting nearly $2.1
billion to protect and promote public health as part of the President's
fiscal year (FY) 2008 budget – more than a 5 percent increase over the
budget submitted to Congress last year.
The budget proposal includes significant increases to strengthen and
modernize safety issues, (drugs and food) speed approval of generic
drugs, and improve the safety and review of medical devices.
$11.2 million and 25 FTEs are requested for modernizing drug safety.
As pointed out by the agency, "FDA needs additional resources to build
on the strong record of safe and reliable drugs…. FDA is proposing to
further strengthen the science that supports its medical product safety
system at every stage of the product life cycle, from pre-market testing
and development through post-market surveillance and risk management."
Specific activities under the Modernizing Drug Safety Initiative are
(amongst others):
- strengthen FDA's ability to assess the benefits and risks of drugs
- conduct a pilot to review the safety profile of new molecular
entities (NMEs) on a scheduled basis
- employ safety experts to identify safety data needs before and after
approval
Generic drug applications submitted to FDA are rising dramatically.
During the past six years, applications increased by 158 percent (307
applications in FY 2002 to 793 in FY 2006). FDA will likely
receive 857 applications in FY 2008.
FDA estimates that the requested $5.6 million increase will allow FDA
to approve or tentatively approve as many as 550 generic drugs per year.
The FDA is also proposing additional funds for generic drug review as
well as a new industry-funded generic drug user fee, which FDA estimates
will generate $15.7 million in FY 2008.
More details about the FY 2008 request, which covers the period of
Oct. 1, 2007 through Sept. 30, 2008, can be found here:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01554.html
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