12 月 8 日，美国众议院能源与商业委员会与参议院卫生委员会宣布双方达成一项两党、两院药品定价法案，称为《2019 降低医疗成本法案》（” The Lower Health Care Costs Act of 2019”）。根据一份 16 页的法案概述，该法案包括与 FDA 相关的几项规定，从橙皮书和紫皮书现代化，到孤儿药，再到生物类似药，等等。其中法案第 407 节概述如下：
有些人可能对上面的简短描述并不感到陌生，因为这是对今年 1 月份在众议院提出的“BLOCKING 法案”（H.R. 938）—《2019 保持对新仿制药激励的同时带来低成本的选择和竞争法案》（“Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019”）的描述。而这项法案源于 2019 财年总统预算请求。这一法案一经发布便引发了业内相关人士的激烈反对，因为这与《Hatch-Waxman 修正案》的主要目标（即，迅速向患者提供高质量、低成本的仿制药）相对立。【美总统预算提案中对 180 天专营权的改变引发业界担忧 2018.02.14】
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:
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.
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.
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.
Patent Certification: Requires ANDA applicants to certify about the listed drug's patents or periods of exclusivity, which can trigger a patent infringement lawsuit.
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.
