Addressing Abusive Citizen Petitions

Abstract

One of the tools brand-name drug companies have used to delay generics involves the filing of questionable citizen petitions with the FDA. This short comment applauds the agency for addressing this pressing issue and offers modifications that would make the proposed guidance stronger.

The FDA can summarily dispose of a petition if its primary purpose is to delay generic entry and if it does not on its face raise a valid scientific/regulatory issue. Though helpful in theory, the agency has never invoked this power in practice.

This comment supports the FDA's attention to elaborating the first of two factors for summary disposition, showing that a petition's "primary purpose" is to delay generic entry. But it calls for a linkage with the second factor, raising a scientific/regulatory issue.

The comment supports referring petitions filed for the primary purpose of delay to the FTC and Congress, and suggests that the FDA provide additional detail in its reports to Congress on which generic applications are delayed, how delay is determined, and the length of delay.

Keywords: citizen petitions, section 505(q), FTC, Congress, generics

JEL Classification: I18, K21, L40, L41, L43, L65, O34, O38