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The Threat of Pandemic Influenza: Are We Ready? Workshop Summary (2005)

Chapter:Appendix C: The Critical Path to New Medical Products

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Suggested Citation:"Appendix C: The Critical Path to New Medical Products." Institute of Medicine. 2005. The Threat of Pandemic Influenza: Are We Ready? Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11150.
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Appendix C
The Critical Path to New Medical Products*

On March 16, the Food and Drug Administration (FDA) released a report addressing the recent slowdown in innovative medical therapies submitted to the FDA for approval, “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.” That report describes the urgent need to modernize the medical product development process—the Critical Path—to make product development more predictable and less costly.

According to Acting FDA Commissioner Lester M. Crawford, “A new focus on updating the tools currently used to assess the safety and efficacy of new medical products will very likely bring tremendous public health benefits.” Because of its unique vantage point, the FDA can work with outside experts in companies, patient groups, and the academic community to coordinate, develop, and/or disseminate solutions to Critical Path problems, to improve the efficiency of product development industry-wide. Through this initiative, the FDA will take the lead in the development of a national Critical Path Opportunities List, to bring concrete focus to these tasks.

We will develop this list through extensive consultation with private and public stakeholders. To this end, we are establishing an open public docket to obtain input on the most pressing scientific and/or technical hurdles causing major delays and other problems in the drug, device, and/or biologic development process, as well as proposed approaches to their

Suggested Citation:"Appendix C: The Critical Path to New Medical Products." Institute of Medicine. 2005. The Threat of Pandemic Influenza: Are We Ready? Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11150.
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solution. In addition, FDA will make internal changes to intensify its ability to surface and address crucial issues and to support high-priority critical path research efforts.

Challenge and Opportunity on the Critical Path to New Medical Products (March 2004)

Suggested Citation:"Appendix C: The Critical Path to New Medical Products." Institute of Medicine. 2005. The Threat of Pandemic Influenza: Are We Ready? Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11150.
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Page388
Suggested Citation:"Appendix C: The Critical Path to New Medical Products." Institute of Medicine. 2005. The Threat of Pandemic Influenza: Are We Ready? Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11150.
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Page389
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Public health officials and organizations around the world remain on high alert because of increasing concerns about the prospect of an influenza pandemic, which many experts believe to be inevitable. Moreover, recent problems with the availability and strain-specificity of vaccine for annual flu epidemics in some countries and the rise of pandemic strains of avian flu in disparate geographic regions have alarmed experts about the world's ability to prevent or contain a human pandemic. The workshop summary, The Threat of Pandemic Influenza: Are We Ready? addresses these urgent concerns.

The report describes what steps the United States and other countries have taken thus far to prepare for the next outbreak of "killer flu." It also looks at gaps in readiness, including hospitals' inability to absorb a surge of patients and many nations' incapacity to monitor and detect flu outbreaks. The report points to the need for international agreements to share flu vaccine and antiviral stockpiles to ensure that the 88 percent of nations that cannot manufacture or stockpile these products have access to them. It chronicles the toll of the H5N1 strain of avian flu currently circulating among poultry in many parts of Asia, which now accounts for the culling of millions of birds and the death of at least 50 persons. And it compares the costs of preparations with the costs of illness and death that could arise during an outbreak.

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