Skip to main content
DrugPrice

Citizen Petition

A formal request filed with the FDA under 21 CFR 10.30 that can be used legitimately or as a delay tactic to slow generic drug approval by raising safety or bioequivalence questions.

How It Works

Citizen petitions allow any individual or organization to formally ask FDA to take specific action on a drug approval matter. Under FDA rules, a citizen petition suspends FDA decision-making on pending ANDAs related to the petition subject until FDA issues a written response, which historically took 150+ days. Branded drug manufacturers have used citizen petitions as generic-delay tools, filing petitions raising bioequivalence concerns, delivery-system differences, or safety issues shortly before ANDA approval decisions. Congress responded in the FDA Amendments Act of 2007 (Section 505(q)) by requiring FDA to respond within 150 days (later tightened to 180 days by FDASIA 2012) and only delay generic approval if the petition raises serious safety or scientific issues not previously considered. FTC enforcement and congressional scrutiny increased in the 2010s: a 2014 GAO study documented that 92% of citizen petitions filed against ANDAs were filed by the brand manufacturer, and most were denied in full or in part. Notable cases include Shire's petitions delaying generic Adderall XR approvals and Mylan's EpiPen-related petitions raising concerns about device equivalence for Teva's generic. Under Section 505(q)(1)(E), FDA can summarily deny petitions it deems filed primarily to delay generic competition. Citizen petitions remain a live issue: the FTC's 2023 PBM report and 2024 orange-book listing challenges complement ongoing petition-abuse concerns. The CREATES Act (2019) addressed a related anti-competitive practice of brand manufacturers refusing to provide product samples for generic bioequivalence testing.

Related Terms

  • Orange Book Listing, The FDA's publication of approved drug products with therapeutic equivalence ratings and associated patent and exclusivity information, used to determine generic substitution.
  • Abbreviated New Drug Application (ANDA), The FDA application pathway for generic drugs, which requires proving bioequivalence to the brand-name drug rather than repeating full clinical trials.
  • Pay-for-Delay Settlement, A patent-litigation settlement in which a brand-name drug manufacturer pays a generic challenger to delay launching its generic version, preserving brand monopoly profits.
  • FDA Approval, The process by which the U.S. Food and Drug Administration evaluates a drug's safety and efficacy through clinical trial data before allowing it to be marketed.

Explore Drug Data

Most Expensive DrugsGeneric Drug WatchSearch All Drugs

About This Definition

This definition is part of the DrugPrice Drug Pricing Glossary, 49 terms explaining how prescription drug pricing works in the United States. All definitions are written in plain language for patients, caregivers, journalists, and healthcare professionals.

this entity is one of the U.S. Medicare prescription-drug pricing concepts that recurs across this site. The definition above is the technical answer; the paragraphs below add the practical context for how the concept connects to the CMS Medicare Part D Drug Spending data data behind every per-entity page on the site.

In the CMS Medicare Part D Drug Spending data data, this concept shapes one or more of the fields that drive the per-entity grades and rankings on this site. The methodology page describes which fields feed into which output; this glossary entry documents the underlying term.

Source: CMS Medicare Part D Spending, 2026.