Dong Ke, Boehm Garth, Zheng Qiang
College of Engineering, Peking University, Beijing, China; Center for Pharmaceutical Information and Engineering Research, Peking University, Beijing, China.
Center for Pharmaceutical Information and Engineering Research, Peking University, Beijing, China.
Value Health. 2017 Jun;20(6):792-798. doi: 10.1016/j.jval.2016.05.003. Epub 2016 Jul 15.
A Food and Drug Administration (FDA) Generic Drug User system, Generic Drug User Fee Amendment of 2012 (GDUFA), started October 1, 2012, and has been in place for over 3 years. There is controversy about the GDUFA fee structure but no analysis of GDUFA data that we could find.
To look at the economic impact of the GDUFA fee structure.
We compared the structure of GDUFA with that of other FDA Human Drug User fees. We then, using FDA-published information, analyzed where GDUFA facility and Drug Master File fees are coming from. We used the Orange Book to identify the sponsors of all approved Abbreviated New Drug Applications (ANDAs) and the S&P Capital IQ database to find the ultimate parent companies of sponsors of approved ANDAs.
The key differences between the previous structure for Human Drug User fees and the GDUFA are as follows: GDUFA has no approved product fee and no first-time or small business fee exemptions and GDUFA charges facility fees from the time of filing and charges a foreign facility levy. Most GDUFA fees are paid by or on behalf of foreign entities. The top 10 companies hold nearly 50% of all approved ANDAs but pay about 14% of GDUFA facility fees.
We conclude that the regressive nature of the GDUFA fee structure penalizes small, new, and foreign firms while benefiting the large established firms. A progressive fee structure in line with other human drug user fees is needed to ensure a healthy generic drug industry.
美国食品药品监督管理局（FDA）的仿制药用户收费系统，即2012年仿制药用户收费修正案（GDUFA），于2012年10月1日启动，至今已实施三年多。关于GDUFA收费结构存在争议，但我们未找到对GDUFA数据的分析。
研究GDUFA收费结构的经济影响。
我们将GDUFA的结构与FDA其他人类药物用户收费结构进行了比较。然后，利用FDA公布的信息，分析了GDUFA设施费和药品主文件费的来源。我们使用橙皮书确定所有已批准的简略新药申请（ANDA）的申办者，并使用标准普尔资本智商数据库查找已批准ANDA申办者的最终母公司。
之前的人类药物用户收费结构与GDUFA的主要差异如下：GDUFA没有批准产品费，没有首次或小企业费豁免，GDUFA从申请之时起收取设施费，并收取外国设施税。大多数GDUFA费用由外国实体或代表外国实体支付。排名前十的公司持有近50%的所有已批准ANDA，但仅支付约14%的GDUFA设施费。
我们得出结论，GDUFA收费结构的累退性质对小型、新成立和外国公司不利，而对大型老牌公司有利。需要一个与其他人类药物用户收费一致的累进收费结构，以确保仿制药行业的健康发展。
