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出自识林

2015-02-03 FDA

FDA新闻稿
2015年2月2日

美国食品药品管理局申请49亿美元的预算，作为总统2016财年预算的一部分用来保障和促进公众健康，比2015财年所制定的预算增加了9%。申请总额包括与几个关键领域相关倡议授权预算的1.477亿美元，包括FDA食品安全现代化法案的实施和关键医药产品问题的管理。

2016财年预算申请反映了FDA履行近年来通过的开创性立法任务的承诺，这增加了FDA的监管责任。FDA的范围也相应扩大，监管了越来越多的来自世界各地的食品和医药产品。

FDA局长Margaret Hamburg博士指出，“这份预算准确地反映了FDA在日益复杂和科学严苛要求的全球监管环境下面临的挑战。FDA的使命在多条战线上展开—从烟草产品的监管到支持个性化医疗的发展再到迎来食品安全的新时代—我们必须拥有资源以运行一个现代化的机构，促进创新，并为美国人民保障最安全的药品和食品供应。

FDA2016财年预算要点包括：

• 实施新的食品安全体系（授权预算方面增加1.095亿美元）：FDA食品安全现代化法案，于2011年由奥巴马总统签署成为法律，要求彻底改变国家食品安全计划以帮助防止食源性疾病，导致许多新法规的制定并大幅加强FDA食品检验能力。2016财年预算申请将允许FDA：对国内食品和饲料安全实施基本要求；获得支持法律实施的技术人员，包括培训新检查员；为产业界提供法律带来变化的适当指南；加强各州在帮助确保国家食品供应安全方面的作用；以及建立和实施新的进口安全系统。
• 提高医药产品安全性和质量（授权预算方面增加3.32千万美元）：由FDA监管的医药产品对美国公众的健康至关重要，并影响着美国医疗保健的几乎每个环节。FDA2016财年申请力图全方位提高整个监管产品的安全性和质量并支持创新。重点包括：打击日益严重的抗生素耐药性威胁；促进发展和适当使用可靠的分子和遗传诊断—也被称为精确医疗工具—以实现“个性化”诊断和治疗疾病；实施《FDA安全与创新法案》的关键要求；应对混合药物和医药产品的安全性问题；实施防晒剂创新法案。
• 构建一个更现代化的FDA（授权预算方面增加5百万美元，加上已经涵盖在之前重点中的2.4千万美元）：2009年以来五项重大开创性立法的通过，极大地增加了FDA的职责。由于FDA任务增加，需要更多科学家、医生、分析师和检查员满足FDA不断发展的使命。与2008财年相比，2016财年FDA人员需求应增加70%。为了解决其扩大的人员队伍和容纳这些人员的设施需求，FDA需要额外的资金用于租金支付和可行性研究，以更新和发布经修订的White Oak场区主计划。

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FDA seeks $4.9 billion for FY 2016 to implement the FDA Food Safety Modernization Act and improve the quality and safety of the medical products Americans use
FY 2016 request reflects a nine percent increase from FY 2015 budget

FDA News Release
February 2, 2015

The U.S. Food and Drug Administration is requesting a budget of $4.9 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2016 budget – a nine percent increase over the enacted budget for FY 2015. The overall request includes $147.7 million in budget authority for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act and the management of critical medical products issues.

The FY 2016 budget request reflects the FDA's commitment to fulfill the mandates of groundbreaking legislation passed in recent years, which has given the agency increased regulatory responsibilities. The FDA's scope has also expanded as it regulates an ever-increasing number of food and medical products imported from all over the world.

“This budget accurately reflects the challenges FDA faces in a global regulatory environment, which is becoming increasingly complex and scientifically demanding,” said Commissioner Margaret A. Hamburg, M.D. “As FDA's mission expands on several fronts –– from the regulation of tobacco products to supporting the development of personalized medicine to ushering in a new era of food safety – we must possess the resources to run a modern agency that fosters innovation and ensures the safest possible drug and food supply for the American people.”

Highlights of the FDA FY 2016 budget include:

• Implementing a New Food Safety System (+$109.5 million in budget authority): The FDA Food Safety Modernization Act, signed into law by President Obama in 2011, required sweeping changes to the nation’s food safety program to help prevent foodborne illness, resulting in multiple new regulations and a substantial strengthening of the agency's food inspection capabilities. The FY 2016 budget request will allow the FDA to: implement fundamental requirements for domestic food and feed safety; acquire the technical staffing needed to support the law, including the training of new inspectors; provide the appropriate guidance to industry about the changes the law will bring; strengthen the role of the states in helping to ensure the safety of the country's food supply; and build and implement a new import safety system.
• Improving the Safety and Quality of Medical Products (+$33.2 million in budget authority): Medical products regulated by the FDA are crucial to the health of Americans and impact nearly every aspect of medical care in the United States. The FDA's FY 2016 request seeks to improve safety and quality and support innovation across the entire spectrum of regulated products. Key priorities include: combating the growing threat of antibiotic resistance; facilitating the development and appropriate use of reliable molecular and genetic diagnostics – also known as precision medicine tools – to “personalize” the diagnosis and treatment of disease; implementing key requirements of the Food and Drug Administration Safety and Innovation Act; addressing the safety of compounded drugs and medical products; and implementing the Sunscreen Innovation Act.
• Building a More Modern FDA (+$5.0 million in budget authority, plus $24.0 million already included in the prior highlights): Five major pieces of groundbreaking legislation passed since 2009 have greatly increased the FDA's responsibilities. As the agency's mandate expands, more scientists, doctors, analysts and inspectors are needed to fulfill the FDA's evolving mission. The FDA's staffing needs must increase by 70 percent by FY 2016, compared to FY 2008. The FDA requires additional funding for rental payments and a feasibility study to update and issue a revised Master Plan for the White Oak campus in order to address its expanded workforce and the facilities needed to accommodate them.

相关资料
FY 2016 FDA Justification of Estimates for Appropriations Committees
FY 2016 Budget Highlights
FDAVoice - FDA's FY 2016 Budget Request