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。FDA不是FTC，阻止反竞争交易做法是FTC的职责。但议会制订了一些法律，意味着要冲击药品创新和获取低成本仿制药之间的微妙平衡，FDA具有实施这些法律，坚守议会打破的平衡的重要职责。

We’ll be unveiling additional aspects of our largerAction Plan and providing updates, as these initial elements are implemented.I’m confident that these actions and the dedicated work of the outstandingstaff in our generic drug program will help to address the issues patients arefacing today when they’re priced out of buying the drugs they need. At themeeting on July 18 we want to hear from the public about ways our current rulesmay not be having their intended effects, and where current policies arefalling short in ensuring the careful balance between new innovation andpatient access.

我们会公开我们更大的执行计划的其它部分，提供更新，因为其基本要素已经实施了。我相信我们仿制药计划中杰出员工的努力工作和这些措施会帮助解决患者今天所面临的药价超高问题。在7月18日的会议中，我们想要听到公众在我们目前所用规定方面的声音，这些规定可能并没有达到预期效果，以及当前政策在确保创新和患者利益微妙平衡时无力的表现。

Our goal is to broaden access to safe and effectivegeneric drugs that can improve access to medicines and help consumers lowertheir health care costs. As in all of the things we do, we will steadfastlymaintain FDA’s gold standard for rigorous, science-based regulation.

我们的目的是扩大安全有效仿制药的来源，改善药品可获得性，帮助消费者降低其卫生健康成本。因为在我们做的所有事情中，我们会稳定快速地维护FDA的严格、基于科学的法规金标。

Over the past five years our generic drug programstaff has evolved and grown remarkably, while implementing the first genericdrug user fee program. The staff has demonstrated that they can rise to newchallenges and they have my full support. Their hard work will serve as astrong foundation for the program as it moves forward. I want the policyframework they operate under to be as efficient, fair, and robust as the reviewprogram that they’re operating.

在过去5年中，在执行首个仿制药用户费用计划中，我们的仿制药计划组员工已显著进步成长。员工已证明了他们可以接受新的挑战，我们也会给予他们全部的支持。在前进中，他们的努力工作将会成为新计划的强大基础。我期望他们工作所在的政策框架作为审核流程来说是有效、公平、稳健的。

Scott Gottlieb, M.D., is Commissioner of the U.S. Food andDrug Administration