Shivdasani Yashna, Kaygisiz Neriman Beste, Berndt Ernst R, Conti Rena M
Wellesley College, Wellesley, MA, USA.
Alfred P. Sloan School of Management, Massachusetts Institute of Technology, Cambridge, MA, USA.
J Law Biosci. 2021 Jan 29;8(1):lsaa085. doi: 10.1093/jlb/lsaa085. eCollection 2021 Jan-Jun.
Prescription pharmaceuticals are frequently used consumer products whose manufacturing location is commonly held as a trade secret by firms and US regulatory agencies. Here we use previously non-publicly available data to describe levels and trends in the manufacturing locations of the most commonly used prescription pharmaceuticals, off-patent generic drugs, intended to be consumed by Americans. We find that the base ingredients required for the manufacturing of these prescription drugs are overwhelmingly and increasingly manufactured in non-domestic locations, specifically India and China. The manufacturing of finished prescription drugs for the American market is more equally split between domestic and foreign locations, but is increasingly foreign as well. The American reliance on non-domestic manufacturing of prescription drugs is important for stakeholders to appreciate, given current quality and pricing concerns and their potential susceptibility to interruptions in supply due to natural disasters, pandemics, and international trade negotiations. We discuss implications of these levels and trends for current domestic and international policy discussions.
处方药是常用的消费品，其生产地点通常被公司和美国监管机构视为商业机密。在此，我们使用此前未公开的数据来描述供美国人消费的最常用处方药、非专利仿制药的生产地点的水平和趋势。我们发现，这些处方药生产所需的基础成分绝大多数且越来越多地在非美国本土生产，特别是在印度和中国。面向美国市场的成品处方药的生产在国内外地点之间的分布更为均衡，但也越来越倾向于国外。鉴于当前对质量和价格的担忧以及它们可能因自然灾害、大流行和国际贸易谈判而受到供应中断的影响，美国对非本土处方药生产的依赖对利益相关者来说很重要。我们讨论了这些水平和趋势对当前国内和国际政策讨论的影响。
