2014年2月28日，仿制药生产商协会召开了一次国会通气会，强调了如果按照食品药品管理局（FDA）处方标签拟议规定草案实施，所产生的经济影响和对数百万美国患者造成的严重危险。“这一规定直接损害了仿制药及其品牌药的“一致性”—这是奠定过去三十年里仿制药成功基石的根本科学原则”，前FDA仿制药办公室副主任Gordon Johnston表示，“拟议规定为相同产品出现不同版本的安全信息铺平了道路，损害了非常重要的一致性原则。美国仿制药生产商协会反对这一拟议规定，但是继续倡导多个利益攸关方合作，寻求不损害患者安全或药品可及性的可行解决方案。“仿制药生产商已经准备好就以某种方式，既不超越FDA的法律权威，也不将患者置于风险之中，改进这一拟议规定，与FDA进行有意义的对话。”仿制药生产商协会的主席兼CEO Ralph G. Neas表示。
编译：识林-Kapok 2014-03-15
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.
