The Future of Drug Safety Promoting and Protecting the Health of the Public (2007) / Chapter Skim
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7 Resources for the Drug Safety System
7 Resources for the Drug Safety System
Pages 193-204
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From page 193... ...
(Thompson, 2000; GAO, 2002) .1 User fees have led to an overall increase in resources for new drug review, but activities not funded by user fees have received a smaller portion of FDA's total budget.
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From page 194... ...
from user fees (see Figures 7-1 and 7-2 for more information on trends in CDER funding and staffing)
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From page 195... ...
Although some of the recommendations are more far-reaching than others, the committee believes each of its recommendations will serve to improve the drug safety system. For the past 15 years, user fees have supported a steadily increasing share of CDER's work.
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From page 196... ...
, staff would have to be eliminated. Yet other CDER staff, particularly CDER leadership and managers, describe PDUFA as setting necessary performance goals that any responsible agency should employ regardless of links to funding source, and deny that the goals are used as anything more than targets.
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From page 197... ...
. Along with performance goals, PDUFA includes restrictions on how CDER can use its funds.
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From page 198... ...
However, if appropriations are not sufficient to fund these activities and user fees are required, Congress should greatly reduce current restrictions on how CDER uses PDUFA funds. Should the sources described above be insufficient, alternatives that could be considered and evaluated by Congress include but are likely not limited to a user fee associated with the consumption of prescription medications and a sales tax on purchase of marketing services by pharmaceutical companies.
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From page 199... ...
. PDUFA funding supported 1320 FTEs for new drug review in 2004 and appropriations supported 1287 FTEs (FDA, 2005a,b)
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From page 200... ...
The FDA commissioner can serve an important role as a champion within the government and in discussions with Congress for needed resources. The committee also recognizes that other federal partners in drug safety will require additional staff to achieve a fully functioning postmarket drug safety system, as described in Chapter 4.
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From page 201... ...
This is based on an estimate for a research institute recently proposed to advance the Critical Path Initiative.13 As Chapter 4 describes, the PPP will have responsibility for prioritizing and planning postmarket studies to address public health concerns, will help advise on the design of such studies (including the postmarket study commitments agreed upon by CDER and industry) , and will facilitate necessary collaborations between government agencies and departments, and the pharmaceutical industry.
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From page 202... ...
0 THE FUTURE OF DRUG SAFETY it would be naïve to suggest otherwise, that on occasion significant new resources will be required to fund a large, prospective, randomized clinical trial to answer drug safety questions of pressing public health concern. Thus, an upper bound estimate of the resources needed for the PPP on such occasions is on the order of $150 million14 to be spread out over the period of time the study is conducted.
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From page 203... ...
2000. User fees for faster drug reviews.
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From page 204... ...
0 THE FUTURE OF DRUG SAFETY Union of Concerned Scientists (UCS)
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