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GDUFA收费标准从哪里来？向哪里去？

首页 > 资讯 > 资讯公开 > GDUFA收费标准从哪里来？向哪里去？

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GDUFA收费标准从哪里来？向哪里去？
GDUFA
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笔记

2015-12-10

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2012年10月1日，仿制药生产商收费法案通过，仿制药企业通过向FDA缴纳申请费和场地费帮助FDA提高ANDA的审评速度。2016财年是GDUFA的第四个年头，经历了审评时长48个月，最高积压近4000件的尴尬时期，FDA也初步完成了1000+员工招募，完善IT系统的基础工作，审评速度有所回升 。但总的收费压力大，FDA每年的结余过高（到2015财年已经结余近$ 3亿），审评速度等仍是下一轮谈判的焦点。那么企业缴纳的GDUFA费用是怎么来的？费用的升高又是怎么计算出的呢？

收费标准怎么来？

GDUFA的每年的收费标准计算，是在经过通货膨胀率及CPI指数等指标调整后的收费总额基础上，除以估算出的当年可能申请份数和工厂数目得到的，在FDA内部评估时会结合上年的申请数和注册工厂数，估算的过程需要向国会提交，并且通过FR Notice向公众报告。

也就是说，GDUFA收费的总数不变，申请越少/厂地越少，每份申请/每个工厂需要交的费用就越多。

GDUFA收费越来越高？

在过去的文章中【2016财年GDUFA收费标准公布】 ，我们探讨过近些年ANDA申请费、PAS申请费，DMF备案费，API及FDF场地费的收费变化。总体来看，由于整个GDUFA的总额受通货膨胀和CPI调整升高，各项收费均有不同程度的升高。其中申请费的变动稍大，而场地费变化相对稳定。

ANDA的申请费，是基于上年的申请数量，结合FDA对下年申请数目的增减确定的，总体来看，在GDUFA后的几年中，ANDA的递交数量低于FDA的预期，事实上，也低于以往十年的递交数量。2014财年的递交数量激增（全年1473件）主要源于“3批6个月”的稳定性政策使得2014年6月单月的申请数量就达到635份。按照图1的趋势，如果2016财年递交的申请数再次走低，ANDA申请费用还将持续上升。

同样的道理，API和FDF的场地费，是根据企业自认定(Self-identified)的厂地信息计算得到的，不过值得注意的是，由于自认定后欠费、补交费、撤销申请等情况，实际的注册工厂与计算收费使用的工厂数存在出入，见图2，图3。按照近4年的趋势，实际注册的厂地数并没有太大的浮动（API厂地数维持在930±20，制剂厂地数维持在700±20的范围内），但FDA预估的厂地数持续下降，这也意味着每年企业需要缴纳的场地费也在不断走高。

仿制药产业格局可能影响收费？

美国制药行业如火如荼的并购游戏使得整个产业的格局产生了微妙的变化，最大的几家仿制药公司纷纷投入制药巨头的怀抱【美国仿制药行业的未来形态？】 ，虽然目前尚未看到被收购的仿制药公司有大规模关闭效益差的工厂这类举措，Pfizer这些制药巨怪的业务重组和资本运作的脚步绝不会停歇。仿制药行业似乎正在偏离Hatch-Wax法案所描绘的，依靠竞争和数量成长的基本设定。GDUFA II期的谈判正在进行，虽然业界对于GDUFA I有诸多不满，但握有批准时间这一筹码的FDA始终在谈判桌上占有一席，保持$3亿的总额不变，企业的减少势必造成剩余企业的负担增大，竞争压力不言而喻。

作者：识林-柯
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Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)

Mandatory Reading:

  • Regulatory Affairs (Reg)
  • Intellectual Property (IP)
  • Quality Assurance (QA)
  • Legal Department

Work Suggestions:

  • Reg: Ensure the company's drug applications comply with the new drug application procedures and bioequivalence standards.
  • IP: Monitor patent term extensions and the impact on the company's patent strategy.
  • QA: Verify that manufacturing processes meet the identity, strength, quality, and purity requirements.
  • Legal Department: Advise on patent infringement issues and the legal implications of abbreviated new drug applications.

Scope of Application:
The Drug Price Competition and Patent Term Restoration Act of 1984 applies to chemical drugs, including new molecular entities and generic drugs, in the United States. It is intended for regulatory bodies, pharmaceutical companies, and legal entities involved in drug development and approval processes.

Key Points Summary:

  1. Abbreviated New Drug Applications (ANDAs): The Act allows for the streamlined approval of generic drugs by submitting abbreviated applications showing bioequivalence to the listed drug, without repeating costly and time-consuming clinical trials.

  2. Patent Term Restoration: Offers a mechanism to extend the effective patent life of a drug to partially compensate for the time lost during the regulatory review process, up to a maximum of five years.

  3. Data Exclusivity: Provides a period of data exclusivity, during which the FDA cannot approve ANDAs for other companies that rely on the innovator's safety and efficacy data.

  4. Patent Certification: Requires ANDA applicants to certify about the listed drug's patents or periods of exclusivity, which can trigger a patent infringement lawsuit.

  5. Regulatory Review Period: Defines the regulatory review period for calculating patent term extensions and sets rules for due diligence during the application process.

Conclusion:
The Drug Price Competition and Patent Term Restoration Act of 1984 is a landmark legislation that balances the need for accessible, affordable medications with the incentive for innovation. It has significantly impacted the pharmaceutical industry by fostering competition and ensuring that both innovator and generic drug companies have clear pathways to market. The above points are not exhaustive; for comprehensive understanding, the full text of the Act should be consulted.

取自“https://lib.shilinx.com/wiki/index.php?title=GDUFA%E6%94%B6%E8%B4%B9%E6%A0%87%E5%87%86%E4%BB%8E%E5%93%AA%E9%87%8C%E6%9D%A5%EF%BC%9F%E5%90%91%E5%93%AA%E9%87%8C%E5%8E%BB%EF%BC%9F”
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