FDA Requests More Budget for Public Health Goals

GMP News No. 888: FDA Requests More Budget for Public Health Goals

GMP News
14 February 2007

FDA Requests More Budget for Public Health Goals

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

Learn more about the FDA and its regulations in the following ECA course:

in Prague, Czech Republic from 26-27 April 2007

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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