Gottlieb指出，鼓励创新和惠及大众的精细产业平衡，是通过《仿制药法案》来实现的。FDA的监管理应在这个框架下开展，而应慎用配药这条法案外的渠道。他文章的最后一段是这样说的：“如果 FDA 显示其法规可以选择性地执行以符合药品定价目标，它可能会面临要求其放松对其它配药的监管。在 Makena 和现在可能在替尔泊肽上开启的先例，可能会让其失去未来对这些关键政策的控制。”（If the FDA shows that its regulations can be selectively enforced to align with objectives on drug pricing, it is likely to face even more pressure to loosen its oversight of other compounded drugs. The precedent it set on Makena, and potentially now tirzepatide, could leave the agency hard-pressed to maintain control over these critical policies in the future.)
这话说的是相当重了。虽然他说的是FDA，但对广义地了解药品监管的精细平衡，也许有借鉴作用。
作者：榆木疙瘩
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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:
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.
