翻译：
JULIA 来源：Julia法规翻译
FDA Workingto Lift Barriers to Generic Drug Competition
FDA
将为仿制药竞争消除障碍
Posted on
June 21, 2017
by
FDA Voice
By: Scott Gottlieb, M.D.
Too many patients are being priced out of themedicines they need. While FDA doesn’t have a direct role in drug pricing, wecan take steps to help address this problem by facilitating increasedcompetition in the market for prescription drugs through the approval oflower-cost, generic medicines.
太多患者正在为其所需药物付出高价。虽然
FDA
不能直接干预药价，但我们可以通过采取措施批准低成本仿制药促进处方药市场竞争来帮助解决这个问题。
Over the last decade alone, competition from safe andeffective generic drugs has saved the health care system about $1.67 trillion.When generics are dispensed at the pharmacy, the immediate savings to each ofus are clear. We could see even greater cost savings if we helped more safe andeffective generic drugs get to market sooner, after patent and statutoryexclusivity periods have lapsed, by addressing some of the scientific andregulatory obstacles to generic competition across the full range ofFDA-approved drugs. These barriers may delay and, in some cases, ultimatelydeny patient access to more affordable drugs.
仅在过去十几年，安全有效的仿制药带来的竞争就为卫生保健系统节省了约
1.67
万亿美元。当仿制药在药房销售时，每个人都能立即感受到这种节省。在专利和行政保护期结束后，通过解决所有
FDA
已批准药物中仿制药竞争路上的一些科学和法规障碍，如果我们帮助更多的安全有效仿制药物更快地进入市场，我们甚至能看到节省更多。在有些情况下，这些障碍可能会延迟甚至最终阻止患者获得更多买得起的药物。
That’s why we’re working on a Drug Competition ActionPlan. As part of this effort, today, we’re announcing in the
Federal Register
our intent to hold a publicmeeting on July 18, 2017, to solicit input on places where FDA’s rules –including the standards and procedures related to generic drug approvals – arebeing used in ways that may create obstacles to generic access, instead ofensuring the vigorous competition Congress intended.
这就是为什么我们要制订药物竞争行动计划。作为工作的一部分，今天，我们在联邦快讯上宣布我们将于
2017
年
7
月
18
日召开公开会议，征求公众对于
FDA
规定的意见
----
包括与仿制药批准有关的标准和程序
----
这些规定可能会对于患者获得仿制药造成障碍，而不是确保议会期望的激烈竞争。
Innovation in pharmaceutical development is essentialbecause it creates new and sometimes life-saving therapies. But access tolower-cost alternatives, once patent and exclusivity periods lapse, also iscritical to the nation’s health.
药物研发创新是必须的，因为它创造了新的治疗方法，有时能挽救生命。但在专利和行政保护期结束后获得低价替代品对于国家人民健康来说也是很重要的。
We know that sometimes our regulatory rules might be“gamed” in ways that may delay generic drug approvals beyond the time frame thelaw intended, in order to reduce competition. We are actively looking at waysour rules are being used and, in some cases, misused.
我们知道有时候我们法规规定可能被“利用”来延迟仿制药批准，使得其时长超过法律制订的原意，以减少竞争。我们正在查看我们的规定会被怎么利用，在有些时候，被滥用。
One example of such gaming is the increasingunavailability of certain branded products for comparative testing. To performthe studies required to develop a generic alternative to a branded drug, a genericsponsor generally needs 1,500 to 3,000 doses of the originator drug. Iunderstand that generic sponsors are willing to buy these products at fairmarket value; but, in some cases, branded companies may be using regulatorystrategies or commercial techniques to deliberately try to block a genericcompany from getting access to testing samples.
这种利用的例子之一就是让某种品牌药品无法获得，因此仿制方无法进行对比测试。在对原创药品进行仿制药研发期间，仿制药主办方通常需要
1500
至
3000
剂原创药。就我所知，仿制药主办方愿意以公平市场价格购买这些药品，但是，在有些情况下，原创公司可能会利用法规策略或商业技巧来故意阻止仿制药公司获得这些测试所需样品。
This might occur, for example, when branded companiesmight use restrictions they place in their commercial contracts or theiragreements with distributors to make it hard for intermediaries in the drugsupply chain to sell the drugs to generic drug developers.
这是可能发生的，例如，原创公司可以在其与销售商的商业合同或协议中加入限制条款，使得药品供应链中中间人难以将药品卖给仿制药研发者。
We also see problems accessing testing samples whenbranded products are subject to limited distribution – whether the company hasvoluntarily adopted limitations on distribution, or the limitations have beenimposed as part of a Risk Evaluation and Mitigation Strategy, or REMS, aprogram that FDA implements to help ensure the safe use of certain drugs. Ihave been made aware that, in some of those cases, branded sponsors may usethese limited distribution arrangements, whether or not they are REMS-related,as a basis for blocking generic firms from accessing the testing samples theyneed.
我们还看到原创药品受到销售限制时，要获得测试样品就会有问题
---
有时是公司主动在销售中实施限制，有时是作为风险评估或风险降低策略的一部分实施限制，或者是
REMS
，
FDA
实施用以帮助确保特定药品的安全使用的程序来实现。我知道的是在有些这样的案例中，原创药主办方可能会使用其限制销售的部署，不管是否
REMS
有关，作为阻止仿制药获得其测试所需药品的依据。
Besides limiting access to testing samples, somebranded companies may be using the statutory default requirement to have asingle shared REMS across both the branded and generic versions of a drug as away to block generic entry. They might prolong negotiations with the genericfirms over the implementation of these single shared systems, which could delaythe entry of safe and effective generic drugs onto the market.
除了限制获取测试样品外，有些原创药公司可能会使用法定默认同一原创药和仿制药要共享同一份
REMS
的要求来阻止仿制药进入市场。他们可能会延长与仿制药公司在实施这些单一共享系统方面的谈判，这就会延迟安全有效药品进入市场。
I want to take steps to address these concerns, tomake sure that we are facilitating appropriate competition in circumstanceswhere Congress intended. The forthcoming public meeting is intended to solicitpublic comment to inform us of circumstances where generic competition may bethwarted by these and other techniques.
我想要采取措施来解决这些让人担忧的问题，以确保我们是在促进议会期望的适当竞争。马上要召开的公开会议意在收集公众意见，让我们了解仿制药竞争可能会被这样那样技巧所阻挠的情形。
As we solicit additional information, we also aregoing to be looking at policy and programmatic changes to address these issues.Some of these steps may be actions we can take by using our own authoritiesmore forcefully. Other steps might involve our need to collaborate with sisteragencies.
在征求信息过程中，我们也将查看是否需要对政策和流程的修改来解决这些问题。我可能会通过更强力地使用我们自己权力来采取措施实施这其中有些步骤。其它措施可能会涉及到我们需要与兄弟机构合作的问题。
We’re also going to be looking hard at how best to coordinatewith the Federal Trade Commission in identifying and publicizing practices thatthe FTC finds to be anti-competitive. FDA is not the FTC. It is the FTC’sresponsibility to prevent anticompetitive business practices. But Congress setout certain laws that are meant to strike a careful balance betweenpharmaceutical innovation and access to lower cost generic products, and FDAhas an important responsibility to enforce those laws in a manner that adheresto the balance struck by Congress.
我们还会努力寻求要如何才能最好地与联邦贸易委员会协调，识别出并公布
FTC
发现的反竞争做法。
