White Emily K
Food Drug Law J. 2017;72(1):189-224.
In August 2015, more than 110 U.S. oncologists published an article detailing the deleterious effects of rising cancer drugs prices and calling for numerous reforms to our prescription drug system. These prices are the result of decades of political maneuvering; they reflect the way our country has chosen to pay for healthcare, to foster and reward innovation, and to promote a national free market system. While these choices have resulted in immense profits for pharmaceutical companies—and subsidized the development of prescription drugs globally—they have also left many cancer patients unable to afford their medications. And, without providing significant improvements in life expectancy, the rising prices of cancer drugs seem like an unreasonable burden on U.S. healthcare spending. A multitude of reforms have been proposed. At the federal level, many of the reforms seek to amend existing regulatory regimes, such as allowing Medicare to negotiate drug prices, reforming the patent system, and allowing patients to import drugs from other countries. The pharmaceutical and biotechnology industries have pushed back against almost all of them. Some of these proposals are more ambitious than others; some more likely to succeed. With costs rising every day, policy makers, legislators, and industry professionals need to focus their attention on those reforms that are attainable and will result in sustainable, reduced prescription drug prices. This paper discusses various U.S. regulatory frameworks that impact prescription drug prices and evaluates proposed reforms to these frameworks in terms of which ones are most likely to succeed.
2015年8月,110多名美国肿瘤学家发表了一篇文章,详细阐述了癌症药物价格上涨的有害影响,并呼吁对我们的处方药系统进行多项改革。这些价格是几十年政治操纵的结果;它们反映了我国选择支付医疗保健费用、促进和奖励创新以及推动国家自由市场体系的方式。虽然这些选择给制药公司带来了巨额利润,并补贴了全球处方药的开发,但它们也让许多癌症患者买不起药。而且,在没有显著提高预期寿命的情况下,癌症药物价格的上涨似乎给美国医疗保健支出带来了不合理的负担。人们提出了许多改革建议。在联邦层面,许多改革旨在修订现有监管制度,比如允许医疗保险谈判药品价格、改革专利制度以及允许患者从其他国家进口药品。制药和生物技术行业几乎对所有这些建议都进行了抵制。其中一些建议比其他建议更具雄心;一些更有可能成功。随着成本每天都在上升,政策制定者、立法者和行业专业人士需要将注意力集中在那些可行且能带来可持续的、降低的处方药价格的改革上。本文讨论了影响处方药价格的各种美国监管框架,并评估了针对这些框架的改革建议,看哪些最有可能成功。