FDA citizen petitions
What is an FDA Citizen Petition?
An FDA Citizen Petition is a formal request submitted by any interested person (including individuals, companies, or organizations) to the Food and Drug Administration (FDA) asking the agency to:
Issue, amend, or revoke a regulation or order.
Take or refrain from taking certain administrative actions.
Address public health concerns related to FDA-regulated products (drugs, medical devices, food, cosmetics).
Purpose and Use
To influence FDA policy or regulatory decisions.
To seek agency action on issues not currently under active agency rulemaking.
To challenge approvals or regulatory positions indirectly.
To raise safety or efficacy concerns about marketed products or pending approvals.
Statutory and Regulatory Framework
Governed by 21 C.F.R. § 10.30.
The FDA must respond to a petition within 180 days (usually extended).
Petitions may request stay of approval or other agency actions.
Submitting a petition does not automatically delay approvals; FDA discretion governs.
Key Legal Issues with FDA Citizen Petitions
Can petitions delay or block FDA approvals?
Courts generally defer to FDA discretion but examine abuse of process or undue delay.
What is the scope of judicial review of FDA responses?
Courts usually give Chevron deference to FDA’s scientific judgments.
Can competitors use citizen petitions to delay rival drug approvals?
“Sham” petitions designed for delay have been subject to legal and legislative scrutiny.
Important Cases Involving FDA Citizen Petitions
1. Alcon Laboratories, Inc. v. FDA, 745 F. Supp. 2d 28 (D.D.C. 2010)
Issue: Can a citizen petition be used to delay approval of generic drugs?
Facts:
Alcon filed a petition raising safety concerns about a generic competitor’s drug.
The FDA delayed generic approval pending petition resolution.
Holding:
The court upheld FDA’s authority to consider citizen petitions but noted the process should not be used to improperly delay competition.
It recognized legitimate safety concerns but warned against abuse.
Significance:
Confirmed FDA’s discretion but highlighted balancing public health and market competition.
Raised awareness of “petition abuse.”
2. FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000)
Issue: Can FDA regulate tobacco products via administrative orders?
Facts:
The FDA attempted to regulate tobacco as a drug/device without explicit Congressional authorization.
Brown & Williamson challenged FDA actions, including petitions seeking or opposing regulation.
Holding:
The Supreme Court ruled FDA lacked authority under the statute to regulate tobacco products as drugs.
FDA citizen petitions cannot expand FDA’s jurisdiction beyond Congressional mandate.
Significance:
Demonstrated limits on FDA authority regardless of petitions.
Emphasized statutory interpretation in evaluating agency power.
3. Coalition for Common Sense in Medicines, Inc. v. Sebelius, 709 F. Supp. 2d 15 (D.D.C. 2010)
Issue: Judicial review of FDA denial of a citizen petition.
Facts:
Petitioners requested FDA to take specific actions related to drug labeling and approval.
FDA denied petition; petitioners sought judicial review.
Holding:
The court deferred to FDA’s scientific judgment, denying the petitioners’ challenge.
Emphasized the broad discretion FDA enjoys in evaluating petitions.
Significance:
Reaffirmed the limited scope of judicial review over FDA scientific and regulatory decisions.
4. Apotex Inc. v. FDA, 414 F.3d 263 (D.C. Cir. 2005)
Issue: Can FDA grant approval of generic drugs while a citizen petition is pending?
Facts:
Apotex filed a citizen petition to delay approval of a generic competitor.
FDA approved the generic despite petition.
Holding:
The court ruled FDA’s approval was lawful despite pending petition.
Citizen petitions do not automatically stay drug approvals.
Significance:
Clarified that citizen petitions do not have suspensive effect unless FDA imposes delay.
5. King Pharmaceuticals, Inc. v. Food and Drug Administration, 702 F. Supp. 2d 126 (D.D.C. 2010)
Issue: Can citizen petitions be abused to delay drug approvals?
Facts:
King Pharmaceuticals alleged a competitor used petitions to delay approval of its products.
Sought relief against abusive petitions.
Holding:
Court recognized potential for abuse, but no automatic remedy exists absent evidence of bad faith.
Highlighted need for procedural reforms.
Significance:
Led to legislative efforts to restrict “sham” petitions (e.g., 2011 FDASIA amendments).
Summary Table of FDA Citizen Petition Case Law
| Case | Key Holding | Impact on Citizen Petitions |
|---|---|---|
| Alcon Laboratories, Inc. v. FDA | FDA can consider petitions but must balance safety vs. market competition | Warned against abuse of petitions for anti-competitive delay |
| FDA v. Brown & Williamson Tobacco Corp. | FDA’s authority is statutory and limited; petitions cannot extend jurisdiction | Defined statutory limits on FDA regulatory authority |
| Coalition for Common Sense in Medicines v. Sebelius | Courts defer to FDA’s scientific judgment denying petitions | Affirmed limited judicial review |
| Apotex Inc. v. FDA | FDA may approve drugs even if petitions are pending | Clarified petitions don’t suspend approvals automatically |
| King Pharmaceuticals, Inc. v. FDA | Abuse of petitions recognized but requires bad faith evidence | Led to calls for procedural reform |
Conclusion
FDA Citizen Petitions are important tools for public participation and regulatory oversight.
However, FDA maintains broad discretion in granting or denying petitions, with courts generally deferring to agency expertise.
The petition process can impact drug approval timing, but does not automatically delay approvals.
Abuse of petitions to delay competitors has been addressed in courts and legislation.
Judicial review of FDA responses is generally limited to procedural fairness and statutory compliance, not scientific judgment.
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