负责监督政府问责的美国联邦政府审计总署GAO在2016年8月的一份报告显示，2010-2015年间，医保Medicare Part D包含的新上市的2,378种仿制药平均会在这5年内有59%的降价，但是在2010年前已经上市的1,441种仿制药里，有315种仿制药在5年中提交超过100% [pdf]4。这其中就包括治疗青光眼的老产品醋甲唑胺在5年内从$0.33提价到$5.47，涨幅达到1,538%。
参考资料：
1 Dave, Chintan V., et al. "High Generic Drug Prices and Market Competition: A Retrospective Cohort Study." Annals of internal medicine 167.3 (2017): 145-151.
2 Gupta, Ravi, et al. "The Impact of Off-Patent Drug Acquisitions on Prices." Journal of general internal medicine (2018): 1-3.
3 Shakil, Saate, and Rita F. Redberg. "New (Very High) Prices on Old Drugs." JAMA internal medicine 177.11 (2017): 1568-1568.
5 Alpern, Jonathan D., William M. Stauffer, and Aaron S. Kesselheim. "High-cost generic drugs—implications for patients and policymakers." New England Journal of Medicine 371.20 (2014): 1859-1862.
9 Graber, Jennifer L. "Excessive Pricing of off-Patent Pharmaceuticals: Hatch It or Ratchet." NYUL Rev. 92 (2017): 1146.
10 Carrier, Michael A., Nicole L. Levidow, and Aaron S. Kesselheim. "Using Antitrust Law to Challenge Turing's Daraprim Price Increase." Berkeley Tech. LJ 31 (2016): 1379.
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.
4。这其中就包括治疗青光眼的老产品醋甲唑胺在5年内从$0.33提价到$5.47，涨幅达到1,538%。
