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Drug importation: limitations of current proposals and opportunities for improvement
Blood Cancer Journal ( IF 12.8 ) Pub Date : 2021-07-15 , DOI: 10.1038/s41408-021-00522-3
Caleb J Scheckel 1 , S Vincent Rajkumar 1
Affiliation  

Drug importation is a policy proposal to help alleviate rising pharmaceutical prices. Restrictions on drug importation stem from the Federal Food, Drug, and Cosmetic Act but authorization of importation can be made by the Health and Human Services (HHS) Secretary. During the Trump administration a number of states passed laws to develop a drug importation programs, however, none have been authorized by HHS. Limitations of these importation programs include sole reliance on Canada, exclusion of high-cost drugs like biologics, and persistent legal hazard of the Personal Importation Program. Potential revisions to current law include expansion of countries approved for importation, inclusion of biologics, and codifying protection for personal importation. Drug importation policies are not a panacea to address rising pharmaceutical prices but may blunt prices while more permanent solutions are pursued.



中文翻译:

药品进口:当前提案的局限性和改进机会

药品进口是一项有助于缓解药品价格上涨的政策建议。对药品进口的限制源于《联邦食品、药品和化妆品法》,但进口授权可以由卫生与公众服务部 (HHS) 秘书授权。在特朗普政府期间,许多州通过了制定药品进口计划的法律,但没有一个州获得 HHS 的授权。这些进口计划的限制包括完全依赖加拿大,排除生物制剂等高成本药物,以及个人进口计划的持续法律风险。对现行法律的潜在修订包括扩大批准进口的国家、纳入生物制品以及编纂个人进口保护。

更新日期:2021-07-16
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