监管的春天来了？

美国忽左忽右的监管政策，但愿不会影响到FDA

1月20日，拜登总统就职当天，签署了17项总统政令。媒体的报道集中在新冠防治、经济救济、环保和移民政策等社会广泛关注的政令上。对药业可能有重要影响的，则是未引起普遍注意的一项名为 “监管审查现代化”（Modernizing Regulatory Review）的政令，要求联邦管理和预算局（OMB）建立指导联邦政府所有部门和机构废除老规和制定新规的政策。所谓老规，就是特朗普执政期间颁布的规章。

4年前，特朗普总统上任的第二周，就发表了著名的“二换一”去监管总统政令，要求联邦政府每制定一项新规章，就要撤销至少两项现行的规章，其核心思想是，政府规章（regulation）是对私营企业（美国无国有企业）和市场经济的干预，应越少越好。尽管褒贬不一，该政策对特朗普执政前三年的经济快速发展，应是不无贡献的。

在美国政法体制下，法律是国会制定的，规章是行政部门和机构制定的。所以，规章是政府行政部门和机构行使权力的利器，为历届政府所重视。1981年里根总统一上任就发布总统政令，要求不得随意制定规章，除非规章给社会带来的益处大于其导致的成本增加。1993年，克林顿总统就职的第一年，就发布总统政令，弱化了里根总统的要求，只要求对导致的成本增加有恰当的说法（justify）。奥巴马总统在第一届任期内发布总统政令，继承了克林顿总统的政策，仅要求说法，不要求量化。该政令写得理顺言明，特将其中译文和原文附在本文后面，并着色关键内容，方便有兴趣者阅读。

当前，拜登总统的政令进一步弱化了行政部门和机构制定规章的自律。例如，提出规章审查的功能是促进规章的制定（… regulatory review serves as a tool to affirmatively promote regulations），而审查的功能原本是为了监督规章制定的。再例如，在开展规章所带来的成本-效益分析时，要“充分考虑”那些难以或不可量化的益处（… “fully accounts” for regulatory benefits that are difficult or impossible to quantify），其中“充分考虑”一词是本届政府的新提法。假想，如果FDA认为将质量文化作为像GMP一样的硬性要求，会有益于保障药品质量，并说这个益处不易量化（其实，细想来，GMP的益处也不是很容易量化。不信，你试试！倒是GMP带来的成本增加是容易量化的），就可以方便地添加一项质量文化的规章。这样下去，往极端了想，以往制定规章时所需开展的成本-效益研究，就可能变得名存实亡了，因为行政部门和机构总可以“益处难以或不可量化”为借口。

上述都是适用于整个联邦政府规章的通用内容，不限于FDA的药监规章。总统是联邦政府所有行政部门和机构的首领。FDA局长的位置历来是总统天降的政治任命，不是靠从下而上的职业晋升。下一步总统提名谁做FDA局长，将显示拜登政府对药品监管政策的风向把握。反正今天是周末，又是杂谈专栏，不妨借着讨论监管的话题，妄议一下这次FDA局长的人选意味着什么。

Janet Woodcock和Joshua Sharfstein目前是局长职位的两位热门人选【FDA 原药品中心主任或将出任代理局长确保平稳过渡 2021/01/15】，【Woodcock 出任 FDA 代理局长 2021/01/22】。前者以同情企业、尤其是创新药企业著称，后者以主张严格监管闻名。业界传闻，2008年底，当选总统奥巴马本计划提名Sharfstein任局长，后因部分参议员强烈反对其严格监管的主张（局长的任命，需要总统提名和参议院批准），才改为提名Margaret Hamburg任局长。若是此次拜登总统提名Sharfstein做局长，那对主张严格监管、多立规章的人来说，不啻为春天的到来。这是因为，拜登曾是奥巴马的副总统，当年的情况他知道，现在明知故做，可见其所图。

作者：榆木疙瘩


附：第13563号行政命令 - 完善规章和监管审查

根据美利坚合众国宪法和法律授予我的总统权力，并为改善监管和监管审查，现命令如下：

第1节 规章原则

（a）我们的监管制度必须在促进经济增长，创新，竞争力和创造就业机会的同时，保护公众健康，福利，安全和环境。它必须基于最佳可用科学。它必须允许公众参与和思想的公开交流。它必须提高预测能力并减少不确定性。它必须确定并使用最佳，最具创新性的以及用于实现监管目标的负担最小的工具。它必须考虑到收益和成本，无论是定量还是定性。它必须确保规章公众可及、自洽、行文简单易懂。它必须衡量并寻求改善规章要求的实际结果。

（b）该命令是对1993年9月30日第12866号行政命令中确立的有关当代监管审查的原则，结构和定义的补充和重申。如该命令中所述，并在法律允许的范围内，每一项除其它外，政府机构必须：（1）仅在合理确定其收益可证明其成本合理的基础上提出或通过一项规章（尽管某些收益和成本难以量化）；（2）调整规章，以在实现规章目标的同时，使社会的负担最小化，同时还应考虑并在切实可行的范围内考虑实施多项规章的累积成本；（3）在其它可供选择的监管方法中选择那些使净收益（包括潜在的经济，环境，公共卫生和安全以及其它益处，对分配的影响，及公平）最大化的方法；（4）在可行的范围内，制定规章的绩效目标，而不是制定受规制对象必须采取的行为或合规方式；（5）确定和评估直接监管的可行替代方案，包括提供经济诱因以鼓励期望的行为，例如使用收费或可销售许可证，或提供可供公众选择的信息。

（c）在运用这些原则时，每个机构都应使用现有的最佳技术来尽可能准确地量化预期的现在和将来的收益和成本。在法律允许和适当的情况下，每个机构都可以考虑（并进行定性讨论）难以量化或无法量化的价值，包括公平，人的尊严，公平和对分配的影响。

第2节 公众参与

（a）条例应通过包含公众参与的程序来通过。为此，规章应在可行和符合法律的范围内，以国家，地方和部落官员，相关学科的专家，受影响的私营部门利益相关者和公众之间的信息和观点的公开交换为基础。

（b）为了促进这种公开交流，每个机构均应符合12866号行政命令和其它适用的法律要求，应努力为公众提供参与监管程序的机会。在法律允许的范围内，每个机构应给公众一个真正的机会，使其可以通过互联网对任何拟议的规章进行评论，评论期通常应至少为60天。在法律允许且可行的范围内，每个机构还应为拟议规章和最终规章提供及时在线读取（通过regulations.gov网站）规章制定文件的清单，包括相关的科学和技术发现，并应采用易于搜索和下载的开放格式。对于拟议规章，在法律允许和允许的范围内，这种读取应包括对规章制定文件的所有相关部分（包括相关科学和技术发现）进行公众评论的机会。

（c）在发布拟议的规章制定通知之前，各机构应在可行和适当的情况下，征求可能受到规章影响的人，包括可能从中受益和受损人的意见。

第3节 整合与创新

一些领域和行业面临着大量的规章要求，其中一些要求可能是多余的，不一致的或重叠的。各机构之间加强协调可以减少这些要求，从而降低成本并简化规章并使其协调一致。在制定监管措施并确定适当的方法时，每个机构都应尝试促进这种协调，简化和统一。每个机构还应酌情寻求实现旨在促进创新的监管目标的手段。

第4节 灵活做法

在适当，可行且符合监管目标的情况下，并在法律允许的范围内，每个机构均应确定并考虑减轻公众负担并保持灵活性和选择自由的监管方法。这些方法包括警告，适当的默认规章和披露要求，以及以清晰易懂的形式向公众提供信息。　

第5节 科学

根据《总统行政部门和机构负责人备忘录》，“科学诚信”（2009年3月9日）及其实施指南，每个机构都应确保用于支持机构监管行为的任何科学技术信息和程序的客观性。

第6节 对现有规章的回顾性分析

（a）为了促进对现有重要规章的定期审查，机构应考虑如何最好地促进对可能过时、无效、不足或过分繁重的规章进行回顾性分析，并据此对规章进行修改、精简、扩展或废除。此类回顾性分析（包括支持数据）应尽可能在线发布。

（b）在该命令发出之日起的120天内，每个机构应制定一项初步计划并将其提交给信息和监管事务办公室（Office of Information and Regulatory Affairs, OIRF），该计划应与法律及其资源和监管重点相一致，根据该计划，机构将定期审查其现有计划确定是否应修改，精简，扩展或废除任何此类规章的重要规章，以使该机构的规章计划在实现规章目标方面更加有效或减轻负担。　

第7节 一般规定

（a）就本命令而言，“机构”应具有第12866号行政命令第3（b）节规定的含义。

（b）此命令中的任何内容均不得解释为损害或以其它方式影响：（i）法律授予部门或机构或其首长的权力；
（ii）管理和预算局(Office of Management and Budget, OMB)局长在预算、行政或立法提案有关方面的职能。

（c）该命令应根据适用法律并在有拨款的情况下执行。　

（d）该命令无意于也不会创造任何权利或利益 , 无论是实质性的还是程序性的，任何一方均可对美国，其部门 , 机关或实体，其高级职员 , 雇员在法律或权益上执行，代理商或任何其它人。

巴拉克*奥巴马，白宫 2011年1月18日。

Executive Order 13563 -- Improving Regulation and Regulatory Review

By the authority vested in me as President by the Constitution and the laws of the United States of America, and in order to improve regulation and regulatory review, it is hereby ordered as follows:

Section 1.General Principles of Regulation. (a) Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation. It must be based on the best available science. It must allow for public participation and an open exchange of ideas. It must promote predictability and reduce uncertainty. It must identify and use the best, most innovative, and least burdensome tools for achieving regulatory ends. It must take into account benefits and costs, both quantitative and qualitative. It must ensure that regulations are accessible, consistent, written in plain language, and easy to understand. It must measure, and seek to improve, the actual results of regulatory requirements.

(b) This order is supplemental to and reaffirms the principles, structures, and definitions governing contemporary regulatory review that were established in Executive Order 12866 of September 30, 1993. As stated in that Executive Order and to the extent permitted by law, each agency must, among other things: (1) propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public.

(c) In applying these principles, each agency is directed to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible. Where appropriate and permitted by law, each agency may consider (and discuss qualitatively) values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts.

Sec. 2.Public Participation. (a) Regulations shall be adopted through a process that involves public participation. To that end, regulations shall be based, to the extent feasible and consistent with law, on the open exchange of information and perspectives among State, local, and tribal officials, experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole.

(b) To promote that open exchange, each agency, consistent with Executive Order 12866 and other applicable legal requirements, shall endeavor to provide the public with an opportunity to participate in the regulatory process. To the extent feasible and permitted by law, each agency shall afford the public a meaningful opportunity to comment through the Internet on any proposed regulation, with a comment period that should generally be at least 60 days. To the extent feasible and permitted by law, each agency shall also provide, for both proposed and final rules, timely online access to the rulemaking docket on regulations.gov, including relevant scientific and technical findings, in an open format that can be easily searched and downloaded. For proposed rules, such access shall include, to the extent feasible and permitted by law, an opportunity for public comment on all pertinent parts of the rulemaking docket, including relevant scientific and technical findings.

(c) Before issuing a notice of proposed rulemaking, each agency, where feasible and appropriate, shall seek the views of those who are likely to be affected, including those who are likely to benefit from and those who are potentially subject to such rulemaking.

Sec. 3. Integration and Innovation. Some sectors and industries face a significant number of regulatory requirements, some of which may be redundant, inconsistent, or overlapping. Greater coordination across agencies could reduce these requirements, thus reducing costs and simplifying and harmonizing rules. In developing regulatory actions and identifying appropriate approaches, each agency shall attempt to promote such coordination, simplification, and harmonization. Each agency shall also seek to identify, as appropriate, means to achieve regulatory goals that are designed to promote innovation.

Sec. 4. Flexible Approaches. Where relevant, feasible, and consistent with regulatory objectives, and to the extent permitted by law, each agency shall identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public. These approaches include warnings, appropriate default rules, and disclosure requirements as well as provision of information to the public in a form that is clear and intelligible.

Sec. 5.Science. Consistent with the Presidents Memorandum for the Heads of Executive Departments and Agencies,

"Scientific Integrity" (March 9, 2009), and its implementing guidance, each agency shall ensure the objectivity of any scientific and technological information and processes used to support the agencys regulatory actions.

Sec. 6.Retrospective Analyses of Existing Rules. (a) To facilitate the periodic review of existing significant regulations, agencies shall consider how best to promote retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned. Such retrospective analyses, including supporting data, should be released online whenever possible.

(b) Within 120 days of the date of this order, each agency shall develop and submit to the Office of Information and Regulatory Affairs a preliminary plan, consistent with law and its resources and regulatory priorities, under which the agency will periodically review its existing significant regulations to determine whether any such regulations should be modified, streamlined, expanded, or repealed so as to make the agencys regulatory program more effective or less burdensome in achieving the regulatory objectives.

Sec. 7.General Provisions. (a) For purposes of this order, "agency" shall have the meaning set forth in section 3(b) of Executive Order 12866.

(b) Nothing in this order shall be construed to impair or otherwise affect: (i) authority granted by law to a department or agency, or the head thereof; or (ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(c) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(d) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

BARACK OBAMA, THE WHITE HOUSE, January 18, 2011

       文章来源：识林

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