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Challenges for the FDA The Future of Drug Safety: Workshop Summary (2007) / Chapter Skim
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2 Addressing the FDA's Resource Challenges
Pages 13-18

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From page 13...
... In 1906, public disclosure of unsanitary conditions in meat-packing plants as documented in Upton Sinclair's The Jungle, the use of poisonous preservatives and dyes in foods, and cure-all claims for worthless and dangerous patent medicines led to the enactment of the Federal Pure Food and Drug Act. This act authorized regulation 1This section is based on the presentation by Jane E
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From page 14...
... To quell growing industry frustration with the unpredictability of the FDA review process, as well as to meet the desperate need of AIDS patients for access to new therapies, Congress passed the Prescription Drug User Fee Act of 1992 (PDUFA) .2 As noted in Chapter 1, recent public health events, such as the withdrawal of Vioxx and the association between the use of selective serotonin reuptake inhibitors (SSRIs)
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From page 15...
... , comprising consumer, patient, industry, and nonprofit groups, reports that the FDA regulates products representing roughly 25 percent of all consumer spending, yet it is expected to meet its expanding mandate with only a fraction of the budget of its sister public health agencies -- the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH)
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From page 16...
... Dr. Henney concluded by expressing her hope that in fiscal year 2008, "both the administration and Congress will be mindful of the incredible needs of the agency." 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
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From page 17...
... Alta Charo, Professor, University of Wisconsin–Madison, and member of the IOM Drug Safety Committee, reiterated that the FDA regulates an extraordinary proportion of the products on the American market in the form of food, drugs, biologics, and medical devices, but operates with a budget that is not commensurate with this broad regulatory authority. Indeed, the committee responsible for the IOM report concluded that the agency's mission of promoting and protecting the health of the American public warrants more public funding in the form of general appropriations, as opposed to PDUFA funds.
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From page 18...
... 5In light of recent events regarding food safety, the Coalition for a Stronger FDA has begun advocating for a $310 million increase in appropriations for 2008 rather than the $175 million previously called for. This figure still includes $40 million for drug reviews and $20 million for medical device programs, but increases funding for food safety programs to $250 million.
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