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By Leslie A. Pray, Sally Robinson

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Extra info for Challenges for the FDA: The Future of Drug Safety, Workshop Summary (Forum on Drug Discovery, Development, and Translation)

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16 CHALLENGES FOR THE FDA 30 NIH CDC FDA 25 $ (Billions) 20 15 10 5 0 1986 1996 2006 FIGURE 2-1 Comparison of NIH, CDC, and FDA budgets between 1986, 1996, and 2006. 1 billion. 2 billion. eps billion. SOURCE: Coalition for a Stronger FDA, 2007. committees are unsympathetic to the agency’s drug safety mission, but because the majority of resources are consumed by the agricultural sector. ” Industry User Fees Mary Pendergast, President, Pendergast Consulting, asserted that since the authorization of PDUFA in 1992, Congress has increasingly relied on user fees rather than congressional appropriations to fund the ADDRESSING THE FDA’S RESOURCE CHALLENGES 17 FDA, a situation that contrasts with the funding provided to CDC and NIH.

FitzGerald, a decade of revolution in drug discovery has resulted in more rationally selected drug targets and molecules directed against those targets than likely was ever anticipated. However, the number of new drugs emerging through the approval process has decreased (Figure 3-1). The current drug development model is not supporting drug discovery. S. drug safety system in balancing benefit and risk. ” That is, while some studies detected a signal from the most selective drug (Vioxx) at a relatively high dose (50 mg/day), virtually all of the epidemiological studies conducted prior to the withdrawal of Vioxx from the market detected a signal at a lower dose (25 mg/day) or at any doses of Celebrex, and none detected a signal from Bextra.

Withdrew rofecoxib (Vioxx), a drug for arthritis, from the market on September 30, 2004. Celecoxib (Celebrex) and valdecoxib (Bextra) are the only two COX-2 inhibitors (“coxibs”) currently being marketed in the United States. However physicians now exercise extreme caution when prescribing those medications. Number of New Molecular Entities Approved STRENGTHENING THE SCIENTIFIC BASE OF THE AGENCY 23 60 50 40 30 20 10 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Year FIGURE 3-1 Number of new drugs approved in the last 10 years (1996–2006).

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