The Burden on Society from Eleventh-Hour 'Citizen Petitions' Filed to Slow Generic Drugs

79 Md. L. Rev. Online 1 (2020)

UC Hastings Research Paper No. 355

16 Pages Posted: 20 Jun 2019 Last revised: 21 Oct 2020

Date Written: June 14, 2019

Abstract

The misuse of the Food & Drug Administration’s citizen petition process is one tactic in a large repertoire of legal maneuvering used by pharmaceutical companies to protect their brand-name drug revenue streams from the introduction of low-cost generics. To date, the financial cost to society of these delays has not been calculated in the literature, which likely hinders the push for policy solutions. Drawing from a previously published data set on 249 citizen petitions, this article identifies four petitions that were highly likely to have been the final obstacle to a generic drug entering the market and for which sufficient volume and usage data were available. Using these four dubious citizen petitions, the total financial cost to society of citizen petition delays was $1.9 billion or $3.6 million per day. The total financial cost to government-provided insurance programs in the same period was roughly $782 million. Due to the conservative methodology employed (choosing only four petitions that met the criteria of “but for” this citizen petition the generic would have gone to market), the estimates are likely low. Citizen petitions that contributed to a generic delay as one of many tactics or for which there was not sufficient volume and usage information were eliminated from consideration in this estimate.

Keywords: citizen petitions, FDA, cost to society, prescription drugs

Suggested Citation

Feldman, Robin, The Burden on Society from Eleventh-Hour 'Citizen Petitions' Filed to Slow Generic Drugs (June 14, 2019). 79 Md. L. Rev. Online 1 (2020), UC Hastings Research Paper No. 355, Available at SSRN: https://ssrn.com/abstract=3404301 or http://dx.doi.org/10.2139/ssrn.3404301

Robin Feldman (Contact Author)

UC Law, San Francisco ( email )

200 McAllister Street
San Francisco, CA 94102
United States

HOME PAGE: http://https://www.uchastings.edu/people/robin-feldman/

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