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2015-11-21 Lachman CONSULTANTS

GDUFA II期谈判正在进行，仿制药办公室（OGD）已开始兑现批准承诺，尽管过去几个月的效率已经明显提升，但尚未达到仿制药行业完全满意的程度。OGD向ANDA持有人展示了他们非常善于发布信息请求（IR）和易更正缺陷（ECD），并在某种程度上，将持有人埋没在了这些信函中，大多数信函给企业回应的周转期为30天。所有的进展都不错，但就像OGD必须处理ANDA的积压一样，行业现在必须学会处理堆放在门口的IR和ECD的积压。ANDA持有人现在必须充分应对新的仿制药审评模式。

这只是向你展示了意向外后果法则证明了什么 – 你永远不知道一方的成功是变成另一方的失败，还是成为另一方的难题！希望随着时间的推移，OGD和行业之间的阴阳变换得以达成平衡，并形成和谐的节奏允许双方完成各自的工作而不把对方压倒。

那么，在对GDUFA I没有完整了解的情况下，如何决定为GDUFA II做些什么？很有兴趣看看谈判的结果，行业和FDA对这项重要立法的第二个5年期重新授权的新要求或修订目标将落脚在何处？

随着国会对行业和FDA双方施压以解决定价问题，这将我带回到1984年，Hatch-Waxman法案首次通过之时。从那时起我们所有的经历不是非常有趣吗？最有趣的是，我们正在听到相同的口号 – 我们需要降低处方药费用。这些年来，我们已经看到抨击仿制药，有偿延迟（pay-for-delay，专利药企业向仿制药企业支付费用，后者承诺在协议期限内不制造、不销售廉价仿制药），专利诉讼，请愿延迟仿制药进入，美国联邦贸易委员会（FTC）介入，制定防止专营权存留的立法，通过立法允许没收180天专营权，风险评估与减轻策略（REMS）和影响仿制药批准的限制分销系统，以及一系列其它企图打破品牌药和仿制药企业间建立起来的微妙平衡的策略。别忘了Hatch-Waxman法案的全称 – 药品价格竞争和专利期恢复法案，旨在提供平等互让的环境和加快批准仿制药的能力。双方都有得有失。仿制药企业得到依赖过去FDA对安全性和有效性的发现而无需重复昂贵和不必要的重复性临床试验的权利。作为回报，品牌药企业获得专利扩展和市场专营期。

现在GDUFA正在重新谈判，焦点仍集中在提高FDA审批仿制药的速度和过程的透明度。1984年，我们曾听到同样的消息。这向我们说明了什么？对当下漠不关心，将注定重蹈历史覆辙！

Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒
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With OGD Teetering on the Precipice of Success – GDUFA II Negotiations Underway
By Bob Pollock | November 20, 2015 |

The Office of Generic Drugs (OGD) would like the generic industry to know that it is poised to bring home the bacon on approvals. The industry has the table set, but, according to some, the meal has yet to be served. This “trust, but verify” position comes at a time when the GDUFA II negotiations are just underway.

OGD has begun to deliver on approvals, although the last few months have shown marked improvement, but not yet at a pace at which the generic industry is entirely pleased. OGD has, however, shown the ANDA sponsors they are very good at issuing Information Requests (IRs) and Easily Correctible Deficiencies (ECDs) and has, in some instances, buried sponsors with such correspondence, most of which have a 30-day turnaround time for the industry response. All well and good, but, just like OGD has had to deal with the backlog of ANDAs, industry must now learn to deal with the backlog of IRs and ECDs piling up at their doors. The new generic drug review paradigm must now be adequately managed at the sponsors.

This just goes to show you what the law of unintended consequences assures – you just never know if one’s success becomes another’s failure or if it will be your problem! Hopefully, over time, there will be a balancing out of this yin and yang between OGD and industry, and a rhythm will develop that will permit both sides to get the job done without overwhelming the other.

So how do you determine what you do for GDUFA II without having a full picture of where GDUFA I has taken you? It will be interesting to see the results of the negotiations, where industry and FDA land on new asks or revised goals for the second 5-year reauthorization of this important legislation.

With Congress placing pressure on both the industry and the Agency to address pricing concerns, it takes me back to 1984, when Hatch-Waxman Act (Waxman-Hatch Act at the time) was first passed. Isn’t it an interesting road we have all traveled since then? The most interesting is that the same mantra is being heard – we need to lower prescription drug costs. Over the years, we have seen generic bashing, pay-for-delay, patent suits, petitions delaying generic entry, the FTC getting involved, legislation enacted to prevent exclusivity parking, legislation passed to permit forfeiture of 180-day exclusivity, REMS and restrictive distribution systems impacting generic approvals, and a number of other strategies advanced that may be a contributor to attempts to upset the delicate balance that was established between the brand and generic industry. Lest we forget the Hatch-Waxman Act’s full title – the Drug Price Competition and Patent Term Restoration Act, designed to provide a give-and-take, and speeding up the ability to approve generic drugs. Both sides gave up something and both sides gained something. Generics got the right to rely on previous Agency findings of safety and efficacy without having to repeat costly and unnecessary duplicative clinical testing, and, in return, brand name companies were rewarded with patent extensions and periods of market exclusivity.

Now that GDUFA is up for renegotiation, the focus is still on improving the speed at which the Agency can review and approve generic drugs and the transparency in that process. In 1984, we were hearing the same message. What does this show us? Without closely monitoring the present, we are doomed to repeat the past!