Fixing the controlled substance quota system: Why the law and the regulator must change

Resilience has become the watchword of American drug policy.

韧性已成为美国毒品政策的口号。

Policymakers across the political spectrum now speak the language of buffer stock, redundancy, and surge capacity—a supply chain’s ability to absorb a shock without leaving patients short.

各个政治领域的政策制定者现在都在谈论缓冲库存、冗余和激增能力——供应链吸收冲击而不导致患者短缺的能力。

Resilience has become a stated federal priority, with executive orders directing agencies to prioritize domestic production, a Food and Drug Administration (FDA) Essential Medicines List meant to focus that effort, a 2025 order to stockpile a six-month supply of active ingredients for dozens of critical drugs, and a run of congressional hearings and proposed bills.

恢复力已成为联邦的一项明确优先事项，行政命令指示各机构优先考虑国内生产，食品和药物管理局 (FDA) 的基本药物清单旨在集中这一努力，2025 年的命令为数十种关键药物储备六个月的活性成分供应，以及一系列国会听证会和拟议法案。

Most of the push is aimed at geopolitical risk, especially exposure to China.

大部分推动都是针对地缘政治风险，尤其是与中国的风险。

One group of drugs stands out against that agenda: controlled stimulants and opioids.

一组药物突出反对这一议程：受控兴奋剂和阿片类药物。

Stimulants for ADHD, relied on by millions of patients, have been chronically hard to obtain since October 2022 .

自 2022 年 10 月以来，数百万患者依赖的 ADHD 兴奋剂一直难以获得。

Injectable opioids listed on the FDA Essential Medicines List —morphine, hydromorphone, and fentanyl—have been in shortage since 2017.

FDA 基本药物清单中列出的注射阿片类药物——吗啡、氢吗啡酮和芬太尼——自 2017 年以来一直短缺。

These shortages hit patients who cannot wait or go without.

这些短缺让患者无法等待或放弃。

When injectable opioids run short, hospitals ration and substitute during surgery, childbirth, and end-of-life care.

当注射阿片类药物短缺时，医院会在手术、分娩和临终关怀期间进行配给和替代品。

When stimulants run short, adults and children with ADHD are left unable to fill the prescriptions they depend on to work and learn .

当兴奋剂短缺时，患有多动症的成人和儿童将无法满足他们工作和学习所依赖的处方。

What sets the controlled substance shortages apart is that a rigid government system turns ordinary disruptions into lasting shortages.

受控物质短缺的独特之处在于，严格的政府体系将普通的破坏变成了持久的短缺。

The current push for resilience targets foreign vulnerability, but here the constraint is domestic and self-imposed—the Drug Enforcement Administration’s (DEA) quota system, too rigid to adjust when demand rises or supply falters.

目前推动复原力的目标是外国的脆弱性，但这里的限制是国内的、自我施加的——美国缉毒局 (DEA) 的配额制度过于严格，无法在需求上升或供应下降时进行调整。

That rigidity runs through every level of the system: the aggregate ceiling DEA sets, how the ceiling is subdivided, when manufacturers receive their share, and how much they may hold in inventory—all connected only loosely to what patients need.

这种僵化贯穿于系统的各个层面：DEA 设定的总上限、上限如何细分、制造商何时收到其份额以及他们可以持有多少库存——所有这些都与患者的需求松散地联系在一起。

Congress has held hearing after hearing on drug shortages and introduced a stack of bills, but none address the quota system behind the controlled substance shortages.

国会就药品短缺问题举行了一次又一次听证会，并提出了一系列法案，但没有一项法案涉及受控药品短缺背后的配额制度。

Congress can fix this, not by telling DEA what to do but by shifting quota administration from DEA to FDA.

国会可以解决这个问题，不是通过告诉 DEA 做什么，而是通过将配额管理从 DEA 转移到 FDA。

DEA’s discretion follows its enforcement mission, and no set of instructions can redirect it against the mission that shapes it; the fix is an agency whose mission is keeping medicine in supply.

DEA 的自由裁量权遵循其执行任务，没有任何指令可以将其重定向到塑造它的任务；解决办法是一个以保证药品供应为使命的机构。

This paper traces how DEA’s administration of the quota system undermines resilience at every level, from the national ceiling to the allocations given to individual manufacturers.

本文追溯了 DEA 对配额制度的管理如何破坏各个层面的弹性，从国家上限到单个制造商的配额。

It then argues that these failures follow from DEA’s enforcement mission rather than from anything supply requires, and that quota administration belongs to FDA—the agency that already approves these drugs, inspects the plants that make them, and answers for keeping them in supply.

然后它辩称，这些失败源于 DEA 的执法使命，而不是任何供应要求，并且配额管理属于 FDA——该机构已经批准了这些药物，检查生产这些药物的工厂，并负责保持它们的供应。

The move requires legislation, and the paper closes by laying out the statutory changes that would support it.

这一举措需要立法，本文最后列出了支持这一举措的法定变更。

The quota system exists to hold controlled substance production to the country’s medical need, a commitment rooted in international treaty and implemented through the Controlled Substances Act (CSA).

配额制度的存在是为了控制受控物质的生产以满足国家的医疗需求，这是一项植根于国际条约并通过《受控物质法》(CSA) 实施的承诺。

The idea is intuitive: cap how much can be made, and less can be diverted.

这个想法很直观：限制可以制造的数量，并减少可以转移的数量。

But it is far harder to do well than the intuition suggests—and doing it badly leaves patients’ medical needs unmet.

但做得好比直觉暗示的要困难得多，做得不好就会导致患者的医疗需求得不到满足。

Congress built the system on two levels in the CSA: an aggregate ceiling on how much of each substance may be made nationally, and, beneath it, individual quotas parceling that ceiling out to manufacturers.

国会在 CSA 中建立了两个层面的系统：每种物质在全国范围内生产的总量上限，以及在其之下将上限分配给制造商的单独配额。

The problems come from how DEA implements that structure.

问题来自 DEA 如何实施该结构。

Its handling of the individual quotas hurts both injectable opioids and ADHD stimulants; for the stimulants, the aggregate ceiling compounds the harm.

它对个人配额的处理损害了注射阿片类药物和多动症兴奋剂；对于兴奋剂来说，总量上限加剧了危害。

DEA fragments each manufacturer’s quota into multiple separate grants and often issues them late in the year, so usable quota can be stranded before production begins.

DEA 将每个制造商的配额分成多个单独的拨款，并经常在年底发放，因此可用配额可能会在生产开始之前搁浅。

The one buffer that could absorb a disruption, inventory, is capped in a way that can prevent a firm from making even the quota it holds.

可以吸收中断的一个缓冲——库存——受到限制，甚至可以阻止公司生产其持有的配额。

And when a disruption does hit, stranded quota cannot be moved to another manufacturer that is able to use it.

当中断确实发生时，搁浅的配额无法转移到另一个能够使用它的制造商。

The fragmentation starts in the statute, which creates two quotas .

碎片化从法规开始，它创建了两个配额。

The aggregate quota is a national ceiling on how much of a substance may be made; beneath it, a manufacturing quota authorizes each facility to produce up to a set quantity of an active ingredient.

总配额是国家对某种物质的生产量的上限；在其之下，生产配额授权每个工厂生产一定数量的活性成分。

A third, the procurement quota , exists only in regulation and authorizes a facility to obtain and use a controlled ingredient as input.

第三种是采购配额，仅存在于法规中，并授权工厂获取并使用受控成分作为投入。

This means a plant making an active ingredient needs manufacturing quota to produce it and procurement quota to buy its controlled inputs, while a plant making the finished dose needs only procurement quota.

这意味着生产活性成分的工厂需要制造配额来生产它，并需要采购配额来购买其受控投入，而生产成品剂量的工厂只需要采购配额。

DEA has since split these quotas into further subcategories.

此后，DEA 将这些配额进一步细分为子类别。

Under DEA’s current procedures, quota does not arrive once a year as the statute contemplates; it arrives in pieces.

根据 DEA 目前的程序，配额不会像法规规定的那样每年到达一次；它是碎片到达的。

Most manufacturers receive only part of their allocation up front and must apply throughout the year for the rest, sometimes repeatedly, waiting months with little insight into how DEA decides what to grant or when.

大多数制造商只预先收到部分拨款，并且必须全年申请其余拨款，有时需要重复申请，等待数月，几乎不了解 DEA 如何决定拨款内容或何时拨款。

Across a few dozen controlled substances, these partial grants and repeated applications add up to roughly 4,000 quota decisions a year , each a point where supply can arrive late, fall short, or misalign with the stage that needs it.

在几十种受控物质中，这些部分拨款和重复申请每年总计大约有 4,000 个配额决定，每个供应点都可能会延迟到达、达不到要求或与需要的阶段不一致。

Inventory is one buffer that can absorb a disruption, but the way DEA sets inventory rules can stop a manufacturer from using quota it has been granted.

库存是一种可以吸收中断的缓冲区，但 DEA 制定库存规则的方式可以阻止制造商使用已授予的配额。

DEA limits how much of a controlled substance a facility may hold at any one time, counting every form it takes—raw material, work in progress, and finished product alike.

DEA 限制一个设施在任何时候可以持有的受控物质的数量，计算其每种形式——原材料、在制品和成品等。

The cap is set as a percentage of the facility’s own recent sales, so a firm trying to produce more than it sold last year—a new generic entrant, say, or one stepping up to cover a competitor’s shortage—may not be allowed to hold enough working material to make even the volume its quota already permits.

该上限是按该工厂近期销售额的百分比设定的，因此，一家试图生产超过去年销售额的公司（例如，一家新的仿制药进入者，或者一家加紧弥补竞争对手短缺的公司）可能不会被允许持有足够的工作材料来生产其配额已经允许的数量。

DEA administers the individual quotas in a way that strips the system of resilience.

DEA 管理个人配额的方式会削弱系统的弹性。

When production shuts down because of a contamination event or equipment breakdown—a recurrent, foreseeable hazard for these drugs—demand shifts to the others.

当由于污染事件或设备故障（这些药物经常出现的、可预见的危险）而导致生产停顿时，需求就会转移到其他药物上。

DEA cannot prevent the disruption, and no regulator could make recovery instant.

DEA 无法阻止这种破坏，也没有任何监管机构可以立即恢复。

But the barriers that keep other manufacturers from stepping in—the inventory cap, the stranded quota, the quota that arrives too late—are DEA’s, and they turn a recoverable disruption into a lasting shortage.

但阻止其他制造商介入的障碍——库存上限、搁浅的配额、配额来得太晚——都是 DEA 的问题，它们将可恢复的中断变成了持久的短缺。

Every individual quota is carved from an aggregate ceiling, the national limit on how much of a substance may be made in a year; for the ADHD stimulants, that ceiling sits below what patients need.

每个单独的配额都是根据总上限划分的，即国家对一年内可以生产的某种物质的数量的限制；对于多动症兴奋剂来说，这个上限低于患者的需求。

DEA is directed to size it to the country’s estimated medical need, but it builds the estimate from past sales.

DEA 的目标是根据该国估计的医疗需求来确定其规模，但它是根据过去的销售情况来进行估计的。

Past sales are a biased measure whenever supply has been constrained, and the bias feeds on itself .

当供应受到限制时，过去的销售量就是一个有偏见的衡量标准，而且这种偏见会自行加剧。

When quota is binding, sales cannot rise to meet growing demand because they reflect only what the quota allows.

当配额具有约束力时，销售额无法增长以满足不断增长的需求，因为它们仅反映配额允许的情况。

And when quota goes unused because the system could not get it into production, recorded sales can fall below even the prior year, which DEA then reads as lower need.

当配额因系统无法投入生产而未使用时，记录的销售额甚至可能低于上一年，DEA 将其解读为需求较低。

Even when other signals point to rising demand—new diagnoses, shortage reports from patients and pharmacies—DEA is slow to correct the ceiling upward, treating some of it as misuse it should not accommodate .

即使其他信号表明需求不断增长——新的诊断、来自患者和药房的短缺报告——DEA 也缓慢地向上修正上限，将其中一些视为它不应该容纳的滥用。

But whether a prescription is warranted is a judgment a production ceiling cannot make.

但处方是否合理是产量上限无法做出的判断。

The aggregate ceiling is not the constraint for injectable opioids.

总量上限不是注射阿片类药物的限制。

DEA’s own figures show injectable products using less than 5% of the relevant substance’s quota, so the ceiling leaves ample room; the injectable failures sit below it, in the individual-quota problems already described.

DEA 自己的数据显示，注射产品使用的相关物质配额不到 5%，因此上限留有足够的空间；在已经描述的个人配额问题中，可注入的失败位于其下方。

On its face, there is a reason why these FDA-regulated prescription drugs have a law enforcement agency heavily involved: legal controlled substances can be diverted, moved out of the legal supply chain into illicit use, whether stolen, resold, or obtained by forged prescription.

从表面上看，这些受 FDA 监管的处方药受到执法机构的大力介入是有原因的：合法受控物质可能被转移，从合法供应链转移到非法用途，无论是被盗、转售还是通过伪造处方获得。

But placing regulatory oversight of licit controlled substance manufacturing in a law enforcement agency was a policy choice, not a necessity.

但将合法受控物质制造的监管交给执法机构是一种政策选择，而不是必要的。

The CSA, enacted in 1970, grew out of a drug-control framework advanced by the Nixon administration that placed law enforcement at the center of what it cast as a war on drugs.

CSA 于 1970 年颁布，源自尼克松政府提出的毒品管制框架，该框架将执法置于其所谓的禁毒战争的中心。

Three years later, Nixon folded its enforcement apparatus , along with several other Department of Justice (DOJ) drug units, into a single new agency built to run that war: the DEA.

三年后，尼克松将其执法机构与司法部 (DOJ) 的其他几个缉毒部门合并为一个专门负责这场战争的新机构：缉毒署 (DEA)。

DEA is built for enforcement: its mission is to investigate and prosecute those who traffic controlled substances, pursued with roughly 10,000 personnel .

DEA 是为执法而建立的：其使命是调查和起诉那些贩运受管制物质的人，并有大约 10,000 名人员进行追捕。

Regulating the legal supply of these drugs falls to one small office within the agency, the Diversion Control Division, whose staff are a small fraction of that total.

监管这些药物的合法供应由该机构内的一个小办公室——转移控制部门负责，该部门的工作人员只占总数的一小部分。

That division’s mandate , on paper, is dual: not only prevent diversion but also ensure an adequate and uninterrupted supply for legitimate medical, scientific, and commercial needs.

从表面上看，该部门的任务是双重的：不仅要防止转移，还要确保为合法的医疗、科学和商业需求提供充足且不间断的供应。

The allocation and timing failures discussed above show how little the broader agency honors the second half of that division’s mission.

上面讨论的分配和时间安排上的失败表明，更广泛的机构对该部门后半部分任务的履行是多么的少。

That imbalance is reflected in DEA’s own mission statement, which emphasizes enforcement and prosecution while making no explicit mention of ensuring adequate supplies for medical use.

这种不平衡反映在 DEA 自己的使命声明中，该声明强调执法和起诉，但没有明确提及确保足够的医疗用品供应。

The policy response to the opioid epidemic reinforced the notion that access is not what DEA should pay attention to.

对阿片类药物流行病的政策反应强化了这样一种观念，即获取不是 DEA 应该关注的问题。

As the epidemic wore on, Congress pressed DEA to cut quotas through hearings, letters, and eventually statute.

随着疫情的蔓延，国会通过听证会、信函以及最终的法规向缉毒局施压，要求其削减配额。

Members faulted DEA for having let opioid production quotas climb during the epidemic and urged it to rein them in.

成员们指责 DEA 在疫情期间让阿片类药物生产配额攀升，并敦促其控制配额。

The SUPPORT Act of 2018 turned that pressure into law, directing DEA to subtract an estimate of diversion from the opioid quota for five named opioids.

2018 年的《支持法案》将这种压力转化为法律，指示 DEA 从五种指定阿片类药物的阿片类药物配额中减去转移估计数。

But DEA took all these signals well beyond the text, treating supply as something to cut across the whole opioid category, and extending that logic to ADHD stimulants, which Congress had never named at all.

但 DEA 所采取的所有这些信号都远远超出了文本范围，将供应视为贯穿整个阿片类药物类别的东西，并将这种逻辑扩展到 ADHD 兴奋剂，而国会根本没有提及这些兴奋剂的名称。

(In fact, Congress originally scheduled ADHD drugs as Schedule III, not subject to quota, with DEA “up-scheduling” them over time .)

（事实上，国会最初将 ADHD 药物列入附表 III，不受配额限制，随着时间的推移，DEA 对其进行了“上调”。）

Diversion and inappropriate use have since often been invoked to justify tightening quota , but quota is the wrong tool for both.

此后经常以转移和不当使用为理由来证明收紧配额的合理性，但配额对于两者来说都是错误的工具。

It acts at the manufacturing stage, while the conduct DEA seeks to change happens downstream, in prescribing, dispensing, and distribution.

它在制造阶段发挥作用，而 DEA 寻求改变的行为发生在下游的处方、配药和分销阶段。

A ceiling cannot single out diversion or inappropriate use; it reaches only the total amount made.

天花板不能单独指出转移或不当使用；它只达到了总金额。

The relevant policy question is not how much medicine to withhold from the whole market, but how to identify and address the specific prescribing, dispensing, or diversion behaviors of concern.

相关的政策问题不是从整个市场扣留多少药品，而是如何识别和解决令人担忧的具体处方、配药或转移行为。

For oral opioids, the meaningful reductions in inappropriate use came through demand-side measures: prescription drug monitoring programs , prescribing guidelines , and enforcement against pill mills .

对于口服阿片类药物，不当使用的显着减少来自需求方措施：处方药监测计划、处方指南和针对药丸厂的执法。

Those tools work by distinguishing appropriate prescribing from inappropriate prescribing, exactly the distinction a quota cannot make.

这些工具的工作原理是区分适当的处方和不适当的处方，而这正是配额无法做出的区分。

Yet quota remains attractive to DEA because it requires no such judgment.

然而配额对 DEA 仍然有吸引力，因为它不需要这样的判断。

It offers a visible response to political pressure, measured in a published number and announced as a reduction in supply.

它对政治压力做出了明显的反应，以公布的数字衡量，并宣布供应减少。

An enforcement agency guards against one kind of error, letting a diverter through, and discounts the other, denying a patient.

执法机构会防范一种错误，让分流器通过，而忽视另一种错误，拒绝病人通过。

Faced with that trade-off, it will predictably keep reaching for the same cut, whatever the drug.

面对这种权衡，可以预见的是，无论使用什么药物，它都会继续追求同样的削减。

DEA’s handling of a 2023 timing change shows the reflex with injectable opioids: it moved Schedule II quota to quarterly allocation over manufacturers’ warnings that it would make production planning “ extremely difficult if not untenable ,” implemented it anyway, and reversed course only as morphine and other injectable shortages loomed.

DEA 对 2023 年时间变化的处理显示了注射阿片类药物的反应：它将附表 II 配额移至季度分配，尽管制造商警告称，这将使生产计划“即使不是站不住脚，也极其困难”，但无论如何还是实施了这一计划，直到吗啡和其他注射剂短缺迫在眉睫时才扭转了方向。

The problem is not one bad decision but an agency whose mission makes such decisions predictable.

问题不在于一个错误的决定，而在于一个机构的使命使这些决定变得可预测。

There was a moment when licit drug supply regulation might have gone to health rather than law enforcement.

曾经有一段时间，合法药品供应监管可能更利于健康而不是执法。

In 1963, President Kennedy’s Advisory Commission on Narcotic and Drug Abuse recommended a deliberate split: drug-trafficking investigation would go to the DOJ, while regulation of the licit manufacture and supply of these drugs, including the authority to set manufacturing quotas, would go to what became today’s Department of Health and Human Services.

1963年，肯尼迪总统的麻醉品和药物滥用咨询委员会建议进行有意的拆分：毒品贩运调查将由司法部负责，而对这些药物的合法生产和供应的监管，包括制定生产配额的权力，将由今天的卫生与公众服务部负责。

The Commission’s reasoning was straightforward: deciding how much medicine the country needs and keeping it in adequate supply turns on clinical questions—how many patients, which conditions, what formulations—while pursuing those who divert it into illicit channels is police work.

该委员会的推理很简单：决定国家需要多少药品并保持充足的供应取决于临床问题——有多少患者、哪些情况、什么配方——而追捕那些将药品转移到非法渠道的人则是警察的工作。

The two call for different expertise and serve different ends, so they belong in different hands.

两者需要不同的专业知识，服务于不同的目的，因此属于不同的人。

The CSA reversed half of that design .

CSA 推翻了一半的设计。

Enacted in 1970, it honored the split on enforcement recommendation, sending trafficking investigation to what became the DEA, but it sent quota to the attorney general as well, placing regulation of the licit drug supply inside a law enforcement agency.

该法案于 1970 年颁布，尊重执法建议上的分歧，将贩运调查交给了缉毒局 (DEA)，但它也将配额交给了总检察长，将合法毒品供应的监管交给了执法机构。

The Kennedy Commission’s logic is as sound now as it was in 1963, and it points to FDA.

肯尼迪委员会的逻辑现在和 1963 年一样合理，它指向 FDA。

FDA already sets the manufacturing standards these facilities must meet, inspects them for compliance, and approves the products they make.

FDA 已经制定了这些设施必须满足的制造标准，检查它们是否符合要求，并批准它们生产的产品。

Quota is the one lever governing these same facilities that sits with a different agency, under a different mission.

配额是管理这些相同设施的唯一杠杆，这些设施由不同的机构负责，承担不同的使命。

Moving it would close a gap in a job FDA already does rather than hand it an unfamiliar one.

移动它会缩小 FDA 已经开展的工作中的空白，而不是交给它一项不熟悉的工作。

FDA works to prevent shortages and to mitigate the ones it cannot prevent, but for drugs under DEA quota its toolkit runs into a wall.

FDA 致力于防止药物短缺并减少其无法预防的药物短缺，但对于 DEA 配额下的药物，其工具包遇到了障碍。

When a disruption hits, FDA’s Drug Shortage Staff contacts the affected maker and its competitors, checks inventory, and asks who can raise output.

当发生中断时，FDA 的药品短缺工作人员会联系受影响的制造商及其竞争对手，检查库存，并询问谁可以提高产量。

For Schedule II drugs, the moves that would close the gap are the ones FDA cannot make: a competitor can raise output only with more quota and can hold the stock to stage that production only within DEA’s inventory limits.

对于附表 II 药物，FDA 无法采取缩小差距的举措：竞争对手只能通过更多配额来提高产量，并且只能在 DEA 的库存限制内持有库存以进行生产。

With control over quota, FDA could also make supply more reliable before any disruption occurs.

通过对配额的控制，FDA 还可以在发生任何中断之前使供应更加可靠。

It holds the plant-level quality and inspection record for every one of these facilities and requires makers of critical drugs to map their supply chain vulnerabilities , so it knows which are reliable, which are single-source, and which are fragile.

它保存着每一个设施的工厂级质量和检查记录，并要求关键药物的制造商绘制其供应链的漏洞图，以便它知道哪些是可靠的，哪些是单一来源的，哪些是脆弱的。

A quota-setter with that record could steer production toward the makers most likely to deliver and away from concentrated, fragile sites, lowering the odds a disruption occurs at all.

具有这一记录的配额制定者可以将生产引导到最有可能交付的制造商，而不是集中、脆弱的地点，从而降低发生中断的可能性。

Ensuring an adequate supply of generic medicines requires both sufficient quota and regulatory predictability.

确保仿制药的充足供应既需要充足的配额，又需要监管的可预测性。

A manufacturer deciding whether to keep making a low-margin generic weighs not just the price but whether regulatory decisions are transparent and predictable: whether it will know how decisions are made, get reasons when an application is denied, and have a path to fix problems.

制造商在决定是否继续生产低利润仿制药时，不仅要考虑价格，还要考虑监管决策是否透明和可预测：是否知道决策是如何做出的，是否在申请被拒绝时得到原因，以及是否有解决问题的途径。

FDA supplies that through published guidance and reasoned decisions, because managing an ongoing relationship with manufacturers is its core function; DEA’s administration of quota offers little of it .

FDA 通过发布的指南和合理的决定来提供这一点，因为管理与制造商的持续关系是其核心职能； DEA 的配额管理提供的很少。

Steering production toward some manufacturers and away from others, as both reliability and access would require, raises two objections.

由于可靠性和可及性的要求，将生产转向某些制造商而不是其他制造商会引起两个反对意见。

First, FDA has long said it does not tell manufacturers what to make.

首先，FDA 长期以来一直表示不会告诉制造商生产什么。

But a quota is permission, not a command: a manufacturer applies for the quantity it wants to produce, and the regulator grants or denies it, exactly as FDA already does with every application to make a drug.

但配额是许可，而不是命令：制造商申请其想要生产的数量，监管机构批准或拒绝，就像 FDA 对每一个药品制造申请所做的那样。

Second, quota necessarily picks among firms.

其次，配额必然在企业之间进行挑选。

But FDA already does that for the sake of access, through published policy rather than ad hoc choice.

但 FDA 已经通过公布的政策而不是临时选择来做到这一点。

In a shortage, it expedites the makers positioned to close the gap and extends them the flexibility it withholds from others.

在短缺的情况下，它可以加速制造商缩小差距，并扩大他们向其他制造商隐瞒的灵活性。

And under its first-generic policy , it prioritizes review of the earliest eligible applications where competition is thin.

根据其第一项通用政策，它会优先审查竞争较弱的最早符合资格的申请。

Control over quota would do more than route supply to reliable makers; it would also let FDA steer it toward the versions patients most need.

对配额的控制不仅仅是将供应路由给可靠的制造商；它还可以让 FDA 将其引导至患者最需要的版本。

FDA cannot today influence which version a manufacturer makes; a firm holding one authorization channels it to the higher-margin brand or formulation, and the version patients depend on goes short.

如今，FDA 无法影响制造商生产哪个版本；持有一项授权的公司将其转为利润率较高的品牌或配方，而患者所依赖的版本就会短缺。

Allocating quota by version would change that: FDA could grant quota for the generic, or for the injectable in short supply rather than the patch, so the authorized supply matches the need.

按版本分配配额会改变这种情况：FDA 可以为仿制药或供应短缺的注射剂而不是贴片授予配额，因此授权供应符合需求。

The firm still chooses whether to produce under that quota; FDA sets only what it is for.

公司仍然可以选择是否按照该配额进行生产； FDA 仅规定其用途。

Moving quota to FDA would do more than improve drug supply; it would make FDA accountable for balancing appropriate access against inappropriate use.

将配额转移给 FDA 不仅可以改善药品供应，还可以改善药品供应。它将让 FDA 负责平衡适当的访问和不适当的使用。

If DEA holds the quota, FDA can treat inappropriate use as someone else’s problem.

如果 DEA 持有配额，FDA 可以将不当使用视为其他人的问题。

Move the quota, and that changes: the pressure to curb inappropriate use would land on FDA.

改变配额，情况就会发生变化：遏制不当使用的压力将落在 FDA 身上。

And because a quota cut denies treatment to appropriate patients along with the rest, FDA could not answer that pressure by cutting supply.

由于配额削减导致适当患者和其他患者得不到治疗，FDA 无法通过削减供应来应对这种压力。

It would have to use the tools it holds, particularly risk evaluation and mitigation strategies (REMS), which can impose conditions on prescribing and dispensing.

它必须使用其拥有的工具，特别是风险评估和缓解策略（REMS），它可以对处方和配药施加条件。

Moving responsibility for administering quotas to FDA would likely be good for DEA.

将管理配额的责任转移给 FDA 可能对 DEA 有利。

Administering supply is a job that runs against the grain of an enforcement agency—it means housing a division whose goal, keeping drugs available, points the opposite way from the agency’s mission of restricting their misuse.

管理供应是一项与执法机构格格不入的工作——它意味着设立一个部门，其目标是保证药品的供应，这与该机构限制滥用药品的使命背道而驰。

The transfer would let DEA focus on the enforcement work it is built for and stop it from answering for supply outcomes it was never equipped to deliver.

此次转移将使 DEA 能够专注于其本来的目的的执法工作，并阻止其对它从未有能力提供的供应结果负责。

Even with quota administration moved to FDA, DEA would keep registration—the gatekeeping function that decides who may make, distribute, dispense, or prescribe a controlled substance.

即使配额管理移交给 FDA，DEA 仍将保留注册——决定谁可以制造、分销、分配或开具受控物质的把关功能。

A manufacturer would hold its DEA registration while applying to FDA for quota, so FDA could grant quota only to a firm whose registration is current, and that quota would lapse automatically if DEA suspended or revoked registration.

制造商在向 FDA 申请配额时将保留其 DEA 注册，因此 FDA 只能向当前注册的公司授予配额，如果 DEA 暂停或撤销注册，该配额将自动失效。

DEA would also retain all its manufacturing-stage enforcement authorities.

DEA 还将保留其所有制造阶段的执法权限。

Regulation of facility-level diversion controls would stay with DEA: security and personnel requirements, recordkeeping, suspicious-order reporting, and the inspections behind them.

设施级转移控制的监管将由 DEA 负责：安全和人员要求、记录保存、可疑订单报告及其背后的检查。

The enforcement tools stay too: an Immediate Suspension Order to halt operations before any hearing when continued operation poses an imminent danger, revocation for cause through an Order to Show Cause, civil penalties, and binding compliance terms through a Memorandum of Agreement.

执法工具也保留下来：当继续运营构成迫在眉睫的危险时，在任何听证会之前停止运营的立即暂停令，通过“说明原因的命令”撤销原因，民事处罚，以及通过协议备忘录约束合规条款。

Every one of these controls and powers attaches to the manufacturer’s DEA registration, which is why registration should also remain with DEA.

这些控制权和权力中的每一项都与制造商的 DEA 注册有关，这就是为什么注册也应保留在 DEA 中。

Nor would the transfer weaken diversion control.

转移也不会削弱转移控制。

Diversion does not originate where the quota sits.

转移并非源自配额所在的地方。

It happens downstream, in distribution, at pharmacies, and in prescribing, not at the manufacturing stage a quota governs.

它发生在下游，在分销、药房和处方中，而不是在配额管理的制造阶段。

DEA’s authority over those downstream stages would not change: it would retain enforcement control over the distributors, pharmacies, and prescribers it registers today.

DEA 对这些下游阶段的权力不会改变：它将保留对其今天注册的分销商、药房和处方者的执法控制权。

Notably, DOJ’s Office of Inspector General did not identify manufacturing quota as a diversion-control tool.

值得注意的是，司法部监察长办公室并未将制造配额视为转移控制工具。

Although the sharp rise in opioid quota featured prominently in its review of DEA’s handling of opioid diversion, none of its nine recommendations proposed using quota to control diversion.

尽管阿片类药物配额的急剧增加在 DEA 对阿片类药物转移处理的审查中占据了显着位置，但其九项建议均未提出使用配额来控制转移。

Instead, it pointed to registration, suspicious-order data, electronic prescribing, and interagency coordination, all aimed at the downstream stages where diversion occurs.

相反，它指出了登记、可疑订单数据、电子处方和机构间协调，所有这些都针对发生转移的下游阶段。

The statutory change that matters most is moving quota-setting from DEA to FDA—the health agency that approves these drugs, inspects the plants that make them, and answers for drug shortages.

最重要的法规变化是将配额设定从 DEA 转移到 FDA，FDA 是批准这些药物、检查生产这些药物的工厂并解决药物短缺问题的卫生机构。

The other changes in this section would help whoever administers quota, but none substitutes for moving it to the agency whose mission fits the job.

本节中的其他变化将有助于管理配额的任何人，但没有什么可以替代将其转移到任务适合该工作的机构。

Cost recovery.

成本回收。

Congress should extend to FDA the cost-recovery authority that currently funds this work at DEA.

国会应将目前资助 DEA 此项工作的成本回收权授予 FDA。

Since 1993, the CSA has required DEA to set registration fees sufficient to recover the full cost of administering its diversion-control program, and the same authority should follow the function to FDA, sized to what it actually costs to administer quota well.

自 1993 年以来，CSA 要求 DEA 设定足以收回管理其转移控制计划的全部成本的注册费，并且同一机构应遵循 FDA 的职能，其规模应根据有效管理配额的实际成本而定。

The transfer burdens FDA with a function Congress has not separately funded only if Congress declines to move the fee with it.

这种转移给 FDA 带来了国会没有单独资助的职能，只有在国会拒绝转移费用的情况下才可以。

DEA would give up little in the transfer.

DEA 在这次转让中不会放弃什么。

Manufacturer registration fees run $3,699 a year across roughly 560 registrants —about $2.1 million, a small fraction of the roughly $650 million Diversion Control Fee Account that funds the program.

大约 560 名注册者的制造商注册费每年为 3,699 美元，约合 210 万美元，只是为该计划提供资金的大约 6.5 亿美元的转移控制费账户中的一小部分。

The function DEA would shed is a minor part of its resourcing, not a stake worth defending—and the modest fees suggest it has never been resourced as more than an afterthought.

DEA 将剥离的职能只是其资源配置的一小部分，而不是值得捍卫的股份——而且适度的费用表明，它的资源配置从来都只是事后才想到的。

Stranded quota.

配额搁浅。

Congress should clarify that the agency in charge could reassign stranded quota.

国会应澄清，主管机构可以重新分配搁浅的配额。

This clarification is needed because the statute spells out only two situations for readjusting quota that has already been granted: when a registrant loses its DEA registration, or when the aggregate is lowered for everyone.

需要进行这一澄清，因为该法规仅规定了两种重新调整已授予配额的情况：当注册人失去其 DEA 注册时，或者当每个人的总量减少时。

It is silent on the far more common case of a compliant manufacturer that cannot use its quota after a contamination event or equipment breakdown, and DEA has read that silence to mean it must wait for the firm to relinquish the quota.

对于合规制造商在污染事件或设备故障后无法使用其配额的更常见情况，DEA 保持沉默，DEA 认为这种沉默意味着它必须等待该公司放弃配额。

The fix is narrow: authority to reclaim demonstrably unusable quota and reallocate it, without cutting the surrendering firm’s future baseline, so that giving up quota it cannot use costs the firm nothing.

解决办法很窄：有权收回明显无法使用的配额并重新分配，而不会削减放弃公司的未来基线，因此放弃无法使用的配额不会给公司带来任何损失。

Imports.

进口。

Because DEA would keep control of imports after the transfer, two statutory changes are needed.

由于 DEA 将在转移后保留对进口的控制，因此需要进行两项法定变更。

First, Congress should set an import-authorization deadline.

首先，国会应设定进口授权的最后期限。

An importer cannot begin arranging the export permits that source countries such as Turkey and Australia require until it holds a U.S. authorization, and that process takes months, so a late authorization means the drug arrives too late for the year it was meant to supply.

进口商必须获得美国授权才能开始安排土耳其和澳大利亚等来源国所需的出口许可证，而这一过程需要数月时间，因此授权晚意味着该药物在其原定供应年份到达得太晚。

Second, a statutory backstop should prevent DEA from using its import permit authority to undercut FDA’s quota.

其次，法定保障措施应防止 DEA 利用其进口许可权来削减 FDA 的配额。

FDA would set the total the country needs, but DEA would still issue the per-shipment import permits.

FDA 将确定该国的需求总量，但 DEA 仍将颁发每批货物的进口许可证。

Without an obligation to support FDA’s estimate, DEA could deny or delay those permits and hold actual imports below the level FDA found necessary, undoing the quota.

如果没有义务支持 FDA 的估计，DEA 可以拒绝或推迟这些许可，并将实际进口量控制在 FDA 认为必要的水平以下，从而取消配额。

Downstream data.

下游数据。

FDA would need better downstream data for both its current role in estimating medical need and the expanded role the transfer would give it in addressing inappropriate use.

FDA 需要更好的下游数据，以了解其目前在估计医疗需求方面的作用，以及转让将赋予其在解决不当使用方面的扩大作用。

The data come in two kinds: DEA systems FDA should be given access to and external prescribing and utilization data.

数据有两种： DEA 系统 FDA 应有权访问外部处方和使用数据。

DEA’s own systems are the first kind.

DEA 自己的系统是第一种。

The Automation of Reports and Consolidated Orders System ( ARCOS ) already tracks distribution to the dispensing level, and the Controlled Substance Ordering System ( CSOS ) captures controlled substance orders transaction by transaction, in close to real time; both sit inside the registration infrastructure DEA keeps, so the ask is a statutory channel routing that information to FDA.

报告自动化和综合订单系统 ( ARCOS ) 已经跟踪到配药级别的分配情况，而受控物质订购系统 ( CSOS ) 则近乎实时地逐笔交易地捕获受控物质订单；两者都位于 DEA 保留的注册基础设施内，因此询问是将该信息路由至 FDA 的法定渠道。

Aside from informing demand estimates, these data could help FDA monitor shortages and inform risk management programs.

除了为需求估计提供信息外，这些数据还可以帮助 FDA 监控短缺情况并为风险管理计划提供信息。

External data are the second.

其次是外部数据。

Using cost-recovery funding, FDA will be able to buy commercial datasets.

利用成本回收资金，FDA 将能够购买商业数据集。

But no commercial dataset is complete enough to support a national quota.

但没有商业数据集足够完整来支持国家配额。

Available prescribing data are samples, limited to the systems that feed them, while comprehensive e-prescribing data are not for sale.

可用的处方数据只是样本，仅限于提供这些数据的系统，而全面的电子处方数据不予出售。

So this data deficit needs a CSA reporting mandate on the intermediaries that route e-prescriptions, de-identified and walled off from law enforcement, giving FDA the comprehensive read on prescribing that no purchase can provide.

因此，这种数据不足需要 CSA 对传输电子处方的中介机构进行报告，取消身份识别并与执法部门隔离，从而使 FDA 能够全面了解处方，这是任何购买都无法提供的。

Diversion subtraction.

导流减法。

Congress should change what DEA’s opioid diversion estimate does.

国会应该改变 DEA 对阿片类药物转移的估计。

The SUPPORT Act of 2018 directs DEA to estimate diversion and subtract it from the quota for five opioids, including two of the three injectable opioids now in shortage.

2018 年的《支持法案》指示 DEA 估计转移情况，并将其从五种阿片类药物的配额中减去，其中包括目前短缺的三种注射阿片类药物中的两种。

The instruction sounds sensible, but medical need and diversion are separate quantities: an estimate of medical need does not include the diverted amount, so subtracting diversion comes out of patient supply, not diverted supply, setting the ceiling below what patients need.

该指示听起来很合理，但医疗需求和转移是分开的数量：医疗需求的估计不包括转移的金额，因此减去转移来自患者供应，而不是转移供应，将上限设置为低于患者需求。

The estimate itself is worth keeping, because knowing where and how much diversion occurs is useful.

估计值本身就值得保留，因为了解转移发生的地点和程度是有用的。

But instead of subtracting it from the manufacturing ceiling, the statute should require DEA to assess where diversion occurs and propose measures to address it there.

但该法规不应将其从制造上限中扣除，而应要求 DEA 评估转移发生的地点，并提出解决该问题的措施。

That is the approach the DOJ inspector general urged: use the data DEA already holds to target diversion where it occurs, rather than cutting the supply reaching patients.

这就是司法部监察长敦促的方法：使用 DEA 已有的数据来确定发生转移的目标，而不是切断对患者的供应。

That would hold DEA accountable for acting on diversion where it actually happens, without denying supply to the patients who depend on the drug.

这将使 DEA 负责在实际发生的转移情况下采取行动，而不拒绝向依赖该药物的患者提供药物。

Quota deadline.

配额截止日期。

The manufacturer-quota deadline also sends the wrong signal, like the diversion subtraction just discussed.

制造商配额的最后期限也发出了错误的信号，就像刚才讨论的转移扣除一样。

The 2018 SUPPORT Act moved the deadline for fixing each manufacturer’s quota to December 1, presumably to give DEA more room to deliberate.

2018 年支持法案将确定每个制造商配额的最后期限推迟到 12 月 1 日，大概是为了给 DEA 更多审议空间。

But a quota is authorization to run a months-long process, so a number that arrives weeks before the production year cannot yield product at the start of it.

但配额是授权运行长达数月的流程，因此在生产年份前几周到达的数字无法在生产年份开始时生产产品。

Congress should move the deadline back to October 1, signaling that quota exists to give manufacturers enough lead time to have product ready when the year begins.

国会应将最后期限推迟至 10 月 1 日，这表明配额的存在可以为制造商提供足够的准备时间，以便在年初时准备好产品。

Much of the current quota system reflects discretionary choices DEA has made over time rather than statutory requirements.

目前的配额制度在很大程度上反映了 DEA 随着时间的推移而做出的酌情选择，而不是法定要求。

Inventory caps, reserve expectations, the procurement and export split, and shortage-response practices should therefore not automatically carry over unchanged when quota moves to FDA.

因此，当配额移交给 FDA 时，库存上限、储备预期、采购和出口划分以及短缺应对措施不应自动保留不变。

Where the inherited regulations do need revisiting, the right design varies by drug, so Congress should not legislate fixed values.

如果继承的法规确实需要重新审视，则正确的设计会因药物而异，因此国会不应立法固定值。

The inventory a hospital injectable can safely hold is not the inventory that makes sense for an oral opioid or a stimulant.

医院注射剂可以安全持有的库存对于口服阿片类药物或兴奋剂来说是没有意义的。

Congress should instead direct FDA to review the transferred guidance and regulations through a benefit-risk lens that weighs patient access against diversion risk, with authority to let the answer differ by drug.

相反，国会应该指示 FDA 通过利益风险视角来审查转移的指导和法规，权衡患者的使用权和转移风险，并有权让答案因药物而异。

Reviewing a rulebook this large is the kind of open-ended work an agency leaves undone without a push, so the direction should carry a deadline and a report to Congress on how each rule was adjusted and why.

审查这么大的规则手册是一种开放式工作，机构在没有推动的情况下就无法完成，因此该指示应该包含最后期限，并向国会报告每项规则的调整方式和原因。

Resilience is the goal everywhere else in American drug policy, but for these medicines, DEA treats any slack as diversion waiting to happen.

韧性是美国毒品政策其他地方的目标，但对于这些药物，美国缉毒局将任何懈怠视为等待发生的转移。

The result is a system built around friction: quota is split into many grants, released late, capped by inventory limits, and locked to the firm that holds it, making supply less responsive when disruptions occur.

其结果是一个围绕摩擦建立的系统：配额被分成许多赠款，延迟发放，受到库存限制的限制，并锁定到持有配额的公司，使得供应在发生中断时反应迟缓。

DEA’s zero-slack posture has consequences.

DEA 的零宽松姿态产生了后果。

In a recent survey of hospital pharmacy executives, 79% reported that shortages of injectable hydromorphone, morphine, and fentanyl had forced meaningful changes to patient care; more than half of clinicians reported avoidable adverse events they attributed to the shortages; and one in five clinicians reported medication errors or near misses, mainly from unfamiliar substitute drugs and difficult dose conversions.

在最近对医院药房管理人员的一项调查中，79% 的人表示，注射用氢吗啡酮、吗啡和芬太尼的短缺迫使患者护理做出了有意义的改变；超过一半的临床医生报告了他们归因于短缺的可避免的不良事件；五分之一的临床医生报告了用药错误或未遂事件，主要是由于不熟悉的替代药物和困难的剂量转换。

The gaps landed where they could least be absorbed: pediatric oncology, obstetric anesthesia, the operating room, and end-of-life care.

这些缺口集中在最难被吸收的领域：儿科肿瘤学、产科麻醉、手术室和临终关怀。

The stimulant shortage has also inflicted a toll.

兴奋剂短缺也造成了损失。

A Centers for Disease Control and Prevention (CDC) survey found that among the roughly one third of adults with ADHD who took stimulants in 2023, more than seven in ten had difficulty filling their prescriptions .

美国疾病控制与预防中心 (CDC) 的一项调查发现，到 2023 年，大约三分之一患有多动症的成年人服用兴奋剂，其中超过十分之七的人难以按处方配药。

Interrupted treatment is a clinical harm, not a logistical one: unmanaged ADHD impairs executive function.

治疗中断是一种临床伤害，而不是后勤伤害：未经管理的多动症会损害执行功能。

And the CDC warned that patients cut off from regulated supply may turn to an illegal market where counterfeit pills made to look like Adderall increasingly contain fentanyl.

疾病预防控制中心警告说，失去监管供应的患者可能会转向非法市场，那里的假药看起来像阿德拉，越来越多地含有芬太尼。

These failures stem from a mismatch between mission and responsibility.

这些失败源于使命和责任之间的不匹配。

FDA answers for drug shortages and patient access; DEA answers for diversion and criminal enforcement.

FDA 对药品短缺和患者准入问题作出答复； DEA 负责转移和刑事执法。

Correcting that mismatch follows the ordinary logic of government: regulation and enforcement are separate functions.

纠正这种不匹配遵循政府的一般逻辑：监管和执法是独立的职能。

DOJ prosecutes those who defraud Medicare, but it does not run Medicare.

司法部起诉那些诈骗医疗保险的人，但它并不负责管理医疗保险。

The same principle should apply to the manufacture of controlled substances.

同样的原则也应适用于受控物质的制造。

Moving quota to FDA will not end shortages.

将配额转移给 FDA 并不能解决短缺问题。

No regulator can prevent every contamination event or equipment failure.

没有任何监管机构能够阻止每一次污染事件或设备故障。

But it would make the system more resilient.

但这将使系统更具弹性。

FDA could weigh which manufacturers have stronger risk management—information it already requires—and place quota where production is most likely to hold up rather than where disruption is likeliest.

FDA 可以权衡哪些制造商拥有更强的风险管理能力（它已经需要的信息），并将配额放在最有可能维持生产的地方，而不是最有可能中断的地方。

When a shortage did hit, it could clear the government-built barriers that now block recovery: the capped supply, the stranded quota, the firms unable to step in.

当短缺确实发生时，它可以清除政府设置的阻碍复苏的障碍：供应上限、配额搁浅、企业无法介入。

Congress should make the transfer and the statutory changes that support it—funding, reallocation authority, the import and data provisions, an earlier quota deadline, and repeal of the diversion subtraction.

国会应该进行转移以及支持转移的法定变更——资金、重新分配权力、进口和数据规定、提前配额期限以及废除转移扣除。

The statutory fixes matter, but the transfer is what changes the mission behind every quota decision, and that is the change that counts.

法定的修正很重要，但转移是改变每个配额决定背后的使命的因素，而这才是最重要的改变。

DEA should keep chasing diversion.

DEA 应该继续追查转移行为。

Deciding how much medicine may be made should belong to FDA.

生产多少药品的决定权应由 FDA 决定。