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2014-10-13 Lachman CONSULTANTS

10月10日FDA公布了特定固定复方药品的新化学实体（NCE）专营性决定的最终指南。指南在2014年2月联邦公告首次通知公布FDA新立场后7.5个月发布。FDA在完成指南之前认真考虑了对草案的评议。

尽管一些当事人对如果化合物之一是首次批准（过去FDA的立场是如果化合物之一先前已获得批准，那么复方产品没有5年保护的资格）的复方产品授予NCE专营权的决定感到满意，其他人对于此变化则面对自己这杯羹（以及在联邦法院）哭泣。为什么对于FDA的新立场有这些不满？因为，“FDA计划在指南发布之日起适用新的解释。因此，重新诠释并不适用于在该指南文件发布前批准的固定复方药品。”这令一些厂商抱怨连连。

对于这一变化的理由解释如下：“FDA意识到固定复方已在某些治疗领域（包括癌症、心血管疾病和感染性疾病）日益普遍。这些产品在给药方案优化和改善患者疗效方面起着重要作用。正如下面的进一步讨论，我们因此修改了过去对于5年NCE专营权规定，以进一步激励特定固定复方产品的开发。” FDA继续表示“我们已经订立重新诠释适用的法律和监管规定，以允许特定固定复方5年NCE专营权更广泛的可用性，从而进一步激励这些重要产品的开发。”

指南还在一些细节中提供了先前决定的历史依据和重新诠释的依据，并引用了提交于2013年的多次请愿概述了为什么FDA应重新考虑其立场。

对于那些已被拒绝5年NCE专营权的复方产品的申请，时机并不好。法院能否被迫看到实施新政策的截止日期的公平性？还是因截止日期带来负面影响的这些企业只是默默的散布言论？人们可以很快的看到与新规则追溯既往相关的一些问题，因为在新的政策下对于一些已获批的复方，ANDA的提交将会被事先排除在外，而在旧的政策下则不会发生这类问题。FDA如何能在不对市场和FDA审评批准过程造成干扰的情况下纠正这一问题？讨论复杂问题！我想，FDA负责人将试图找出如何处理个别案例，因此截止日期看起来是有道理的！

Lachman CONSULTANTS - Bob Pollock先生 2014-10-10
校译：识林-椒 2014-10-13

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Not All Are Happy with FDA's Final Guidance on NCE Exclusivity for Combination Products!
Written by Bob Pollock • October 10, 2014

Today, FDA published its final guidance on New Chemical Entity (NCE) Exclusivity Determinations for Certain Fixed-Combination Drug Products. The Guidance comes about 7.5 months after the February 2014 Federal Register notice first announcing the new Agency position was published. The Agency carefully considered the comments to its draft proposal before finalizing the Guidance today.

While some parties are happy with the decision to award NCE exclusivity if one of the components is a first time approval (the previous Agency position was that if one component had been previously approved, then the combination was not eligible for the 5-year protection), others are crying in their soup (and in Federal Court) about the change. Why are some unhappy with the Agency’s new positon? Because, “FDA intends to apply the new interpretation from the date of this guidance's publication [and] [T]herefore, the new interpretation will not apply to fixed-combination drug products that were approved prior to the publication of this guidance document.” This has some manufacturers crying foul.

The rationale for this change is explained as follows: “The Agency recognizes that fixed-combinations have become increasingly prevalent in certain therapeutic areas (including cancer, cardiovascular, and infectious disease) and that these products play an important role in optimizing adherence to dosing regimens and improving patient outcomes. As further discussed below, we are therefore revising our historical interpretation of the 5-year NCE exclusivity provisions to further incentivize the development of certain fixed-combination products.” FDA further goes on to say, “We have concluded that interpreting the applicable statutory and regulatory provisions to permit broader availability of 5-year NCE exclusivity for certain fixed-combinations would further incentivize the development of these important products.”

The Guidance goes on to provide the historical basis for its previous decisions and the basis for its new interpretation in some detail and cites back to several petitions submitted in 2013 outlining the rationale for why the FDA should reconsider its position.

For those whose applications for combination products were denied the 5 year NCE exclusivity, the timing was just bad. Will the courts be brought in to look at the fairness of the cutoff date for implementation of the new policy, or will the firms negatively impacted by the cutoff date just go about their business quietly? One can quickly see some of the problems associated with making the new rule retroactive, as submissions of an ANDA would have been precluded for some of the previously approved combinations under the new policy where they were not under the old policy. How would FDA rectify that issue without causing disruption to the marketplace and the FDA review and approval process? Talk about complex! I think the Agency's head would explode trying to figure out how to deal with individual cases, so the cutoff date seems to make perfect sense to me! If you have further questions on this Guidance document please contact Joan Janulis at j.janulis@lachmanconsultants.com