The effects of lobbying on the FDA’s recall classification

Author:

Zhou YifanORCID

Abstract

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.

Publisher

Springer Science and Business Media LLC

Subject

Health Policy,Health (social science),Issues, ethics and legal aspects

Reference17 articles.

1. US FDA. Fact Sheet: FDA at a Glance. https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance. Accessed 27 July 2020.

2. US FDA. Regulatory Procedures Manual Chapter 7: Recall Procedures. https://www.fda.gov/media/71814/download. Accessed 27 July 2020.

3. Drutman Lee. The business of America is lobbying: How corporations became politicized and politics became more corporate. Oxford University Press. https://doi.org/10.1093/acprof:oso/9780190215514.001.0001

4. Clerk of the US House of Representatives. Lobbying Disclosure Act Guidance. https://lobbyingdisclosure.house.gov/amended_lda_guide.html. Accessed 10 Oct 2022.

5. Robert S. Election 2008 – campaign contributions, lobbying, and the US health sector. N Engl J Med. 2007;357:736–9. https://doi.org/10.1056/NEJMp078151.

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