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游说活动对 FDA 召回分类的影响。

The effects of lobbying on the FDA's recall classification.

机构信息

Fanhai International School of Finance, Fudan University, 220 Handan Road, Yangpu District, Shanghai, 200433, China.

出版信息

BMC Med Ethics. 2023 Jun 20;24(1):41. doi: 10.1186/s12910-023-00921-0.

DOI:10.1186/s12910-023-00921-0
PMID:37340417
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10280948/
Abstract

BACKGROUND

The US Food and Drug Administration (FDA) regulates goods accounting for 20% of US consumers' total expenditure. The agency's potential susceptibility to corporate lobbying and political influence may adversely affect the its abilities to fulfill its duties as a vital federal agency. This study assesses whether the FDA's product recall classifications in recall scenarios are influenced by firms' lobbying activities.

METHODS

The universe of all FDA recalls between 2012 and 2019 is obtained from the FDA's website. Firm names are matched to federal-level lobbying data obtained from the Center for Responsive Politics - a non-profit and nonpartisan organization that tracks lobbying expenditures and campaign contributions. Analyses are conducted using ordinary-least-squares regressions, in which the dependent variable is recall classification and independent variables are three different measures of firms' lobbying activities in the one year prior to the recall.

RESULTS

Firms that engage in lobbying appear more likely to receive favourable classifications from the FDA. When examining the above results by product type, we find that classification of food recalls seems to be subject to lobbying influence, but the same does not appear to be true for drug and device recalls. Evidence is consistent with the conjecture that the distinction between medical and food firms may be a result of medical firms targeting lobbying efforts at FDA approvals, rather than recalls.

CONCLUSIONS

Between 2012 and 2019, the FDA's product recall classifications seem to be significantly influenced by firms' lobbying activities. Lobbying firms appear to have received more favorable (i.e., less severe) recall classifications compared to non-lobbying firms.

摘要

背景

美国食品和药物管理局(FDA)监管着占美国消费者总支出 20%的商品。该机构可能容易受到企业游说和政治影响,这可能会对其履行作为重要联邦机构的职责的能力产生不利影响。本研究评估了 FDA 在召回情况下的产品召回分类是否受到公司游说活动的影响。

方法

从 FDA 网站获取 2012 年至 2019 年期间所有 FDA 召回的完整信息。将公司名称与从非营利性和无党派组织“政治响应中心”获得的联邦一级游说数据相匹配,该组织跟踪游说支出和竞选捐款。使用普通最小二乘法回归进行分析,其中因变量是召回分类,自变量是公司在召回前一年进行的三种不同的游说活动的衡量标准。

结果

参与游说的公司似乎更有可能获得 FDA 的有利分类。当按产品类型检查上述结果时,我们发现食品召回的分类似乎受到游说影响,但药品和设备召回似乎并非如此。有证据表明,医疗公司和食品公司之间的区别可能是由于医疗公司将游说努力针对 FDA 批准,而不是召回。

结论

在 2012 年至 2019 年期间,FDA 的产品召回分类似乎受到公司游说活动的显著影响。与非游说公司相比,游说公司似乎获得了更有利(即不太严重)的召回分类。

相似文献

1
The effects of lobbying on the FDA's recall classification.游说活动对 FDA 召回分类的影响。
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2
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本文引用的文献

1
Lobbying Expenditures and Campaign Contributions by the Pharmaceutical and Health Product Industry in the United States, 1999-2018.美国制药和保健品行业 1999-2018 年的游说支出和竞选捐款。
JAMA Intern Med. 2020 May 1;180(5):688-697. doi: 10.1001/jamainternmed.2020.0146.
2
Future jobs of FDA's haematology-oncology reviewers.美国食品药品监督管理局血液肿瘤学审评员的未来工作。
BMJ. 2016 Sep 27;354:i5055. doi: 10.1136/bmj.i5055.
3
Lobbying, campaign contributions, and health care reform.游说、竞选捐款与医疗保健改革。
N Engl J Med. 2009 Dec 3;361(23):e52. doi: 10.1056/NEJMp0910879. Epub 2009 Nov 18.
4
Campaign contributions, lobbying, and the U.S. health sector--an update.竞选捐款、游说与美国医疗行业——最新情况
N Engl J Med. 2008 Sep 25;359(13):1313-5. doi: 10.1056/NEJMp0807073.
5
Election 2008 - campaign contributions, lobbying, and the U.S. Health Sector.2008年选举——竞选捐款、游说活动与美国医疗行业
N Engl J Med. 2007 Aug 23;357(8):736-9. doi: 10.1056/NEJMp078151.