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# Companies Use Petitions to Delay Generics: Study
- URL: https://www.fdaweb.com/companies-use-petitions-to-delay-generics-study/
- Published: 2017-03-02T12:00:00.000Z
- Updated: 2026-09-14T22:09:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138112

Drug companies often use the citizen petition process as a strategy to delay generic competition, according to a study from the University of California Institute for Innovation Law reported in the *New England Journal of Medicine*. The authors reviewed 12 years of FDA citizen petition data and found that drug companies frequently raise “frivolous or questionable claims in a last ditch effort to hold off competition.”

“In examining all citizen petitions filed between 2000 and 2012 that could have delayed a generic’s market entry,” the authors write, “we found widespread, strategic use of the citizen petition pathway by drug companies striving to hold off competition. Specifically, nearly half of the petitions in the final data set were filed within a year and a half before FDA approved the generic, with roughly 40% filed a year or less before generic approval. The clustering of filings at the end of the approval process suggests that the motive is delay. It is possible that the company filing the petition became aware of the problem it purported to see with its competitor’s application only late in the process. FDA has noted, however, that many petitions ‘contained data that had been available to the petitioner well before the date of the petition.’ Thus, it appears that a large proportion of drug companies are using citizen petitions as an 11th\-hour effort to prevent generic competitors from gaining FDA approval and entering the market.”

The report notes that in 2007 Congress amended the Food, Drug and Cosmetic Act in an attempt to block potential avenues for abuse by requiring that FDA respond to citizen petitions related to generics within 180 days (shortened to 150 days in 2012) and providing that it can summarily deny petitions that are intended to delay generic entry and “raise no valid scientific or regulatory issues.”

But the authors contend those changes have been largely toothless given that the number of delay-related petitions continued to grow despite the changes in response time and given that FDA has not summarily denied any petition.

Policies they suggest that could address the issue include: 

- prohibiting companies from filing citizen petitions referencing generic drug applications;
- pursuing punitive measures to deter drug companies from manipulating the citizen participation process; and
- erecting procedural blocks such as 11/2016 rules specifying that FDA cannot delay approval of a pending generic drug unless a delay is necessary to protect the public health.

“Regardless of the policy approach taken,” the authors conclude, “greater transparency is essential. As we collected data, gaps in FDA’s current system for publicly available information came into sharp relief. Finding information as basic as application filing dates for generic drugs required poring through volumes of letters and approval documents, and the information we sought was often entirely absent. Without increased transparency, society cannot curb strategic behaviors such as citizen petition abuse. And as always, the public pays the cost.”