Citizen petitions on drug safety reviews
✅ What Is a Citizen Petition?
Under 21 C.F.R. § 10.30, a citizen petition is a formal request submitted to the U.S. Food and Drug Administration (FDA) by an individual, organization, or company asking the agency to:
Issue, amend, or revoke a regulation or order,
Take or refrain from taking administrative action, or
Review safety, labeling, or approval standards for drugs (among other things).
These petitions are public, must be supported by evidence, and are an important avenue for influencing FDA decision-making on drug safety reviews, including approval, labeling, or withdrawal of pharmaceutical products.
⚖️ Legal Basis
21 U.S.C. § 355: Governs drug approval and safety regulations.
Administrative Procedure Act (APA): Citizen petitions are part of the administrative process and must receive a reasoned response.
21 C.F.R. § 10.30: Establishes formal petition procedures.
FDA Modernization Act of 1997: Set timelines and transparency rules.
FDAAA (2007): Added further safety evaluation and risk oversight.
🔍 Common Grounds for Drug Safety Citizen Petitions
Requesting FDA to revoke or suspend drug approval due to new adverse safety data.
Urging new or stronger warning labels.
Challenging the safety or efficacy of generic versions.
Protesting inadequate clinical trial evidence.
Delaying competitor drug approvals (less legitimate use).
⚖️ Important Case Law on Citizen Petitions and Drug Safety
1. Nat. Res. Def. Council (NRDC) v. FDA, 760 F.3d 151 (2d Cir. 2014)
Facts: NRDC submitted citizen petitions asking the FDA to withdraw approvals for certain antibiotics used in animal feed, citing human drug resistance concerns. The FDA denied the petitions.
Issue: Did the FDA violate the APA by denying the petitions without initiating formal withdrawal proceedings?
Holding: The Second Circuit held that the FDA did not act arbitrarily in denying the petition because the agency has discretion under the FDCA to prioritize its actions.
Significance: Shows that while citizens can petition, the FDA retains broad discretion in how and when it responds, especially in matters involving complex scientific risk assessments.
2. In re Ciprofloxacin Hydrochloride Antitrust Litigation, 363 F. Supp. 2d 514 (E.D.N.Y. 2005)
Facts: The case involved allegations of anti-competitive practices, including use of citizen petitions to delay generic competition for the antibiotic Cipro.
Issue: Whether citizen petitions were part of a strategy to unlawfully delay generics.
Holding: While the case centered on antitrust, it acknowledged how citizen petitions can be misused as a "sham" to interfere with competition.
Significance: Warns that citizen petitions may trigger scrutiny under antitrust law if used to block generics without legitimate scientific basis.
3. AAPS v. FDA, 358 F. Supp. 2d 1 (D.D.C. 2005)
Facts: The Association of American Physicians and Surgeons (AAPS) filed a petition asking the FDA to ban the drug mifepristone (RU-486), citing safety risks.
Issue: Whether the FDA acted improperly in denying the petition.
Holding: The court upheld the FDA’s decision, emphasizing that the agency has expert discretion and that petitioners failed to provide compelling new evidence.
Significance: Reinforces that courts will defer to FDA expertise unless the agency's response is arbitrary or capricious.
4. Pfizer Inc. v. Shalala, 182 F.3d 975 (D.C. Cir. 1999)
Facts: Pfizer challenged the FDA’s approval of a generic competitor, alleging procedural irregularities and safety concerns via a citizen petition.
Issue: Whether the FDA’s handling of the petition and approval process violated administrative law.
Holding: The D.C. Circuit ruled that the FDA’s decision was lawful and consistent with its regulatory framework.
Significance: Sets precedent for limited judicial interference in FDA petition responses when the agency follows proper procedures and justifies its decisions.
5. Teva Pharmaceuticals USA, Inc. v. FDA, 182 F.3d 1003 (D.C. Cir. 1999)
Facts: Teva used a citizen petition to delay the approval of a competing generic drug, citing safety issues and equivalence concerns.
Issue: Whether the FDA lawfully denied the petition and approved the competing drug.
Holding: The court upheld the FDA’s authority and its reasoning for denying the petition.
Significance: Highlights that even when competitive interests are at stake, courts will uphold the FDA’s discretion as long as it provides a rational explanation.
6. ViroPharma, Inc. v. Hamburg, 898 F. Supp. 2d 1 (D.D.C. 2012)
Facts: ViroPharma submitted numerous citizen petitions regarding a proposed generic version of its drug Vancocin, raising manufacturing and safety issues.
Issue: Whether FDA’s delay in ruling on the petitions affected the agency’s authority to approve generics.
Holding: The court noted concern over strategic abuse of citizen petitions, which the FDA later cited in tightening its policy on petitions delaying generics.
Significance: Illustrates the tension between valid safety concerns and anti-competitive misuse of the citizen petition process. Later influenced new FDA guidance on petitions.
7. Astellas Pharma US, Inc. v. FDA, 642 F. Supp. 2d 10 (D.D.C. 2009)
Facts: Astellas filed a petition arguing that a competing generic had labeling that was not identical, raising safety and efficacy concerns.
Issue: Whether FDA was wrong to approve the generic while denying the petition.
Holding: The court deferred to the FDA’s expertise, finding the label differences to be minor and non-material to safety.
Significance: Confirms FDA’s authority to determine what labeling differences are acceptable, despite manufacturer objections in petitions.
🧠 What Do These Cases Teach Us?
1. FDA Has Broad Discretion
Courts consistently defer to the FDA’s scientific judgment unless the agency acts in an arbitrary or procedurally flawed manner.
2. Petitions Must Be Evidence-Based
Petitions lacking robust scientific data or relying on speculation are routinely denied and upheld by courts.
3. Petitions Can Be Abused
Cases like In re Cipro and ViroPharma show how citizen petitions can be used anti-competitively to delay drug approvals. The FDA has implemented safeguards to prevent this.
4. APA Provides a Legal Standard
Denials of petitions are judged under the “arbitrary and capricious” standard of the Administrative Procedure Act.
5. Labeling and Bioequivalence Disputes Are Common
Many petitions target labeling or bioequivalence of generics, especially in attempts to delay generic entry.
📝 Summary
| Legal Point | Key Case | Outcome |
|---|---|---|
| FDA discretion on safety concerns | NRDC v. FDA (2014) | Courts defer to FDA expertise |
| Anti-competitive petition misuse | In re Cipro (2005) | Abuse of process leads to antitrust scrutiny |
| Challenging generic drug safety | Teva v. FDA (1999) | FDA’s decision upheld; evidence must support petition |
| First Amendment concerns (indirectly) | AAPS v. FDA (2005) | FDA safety decisions not easily overturned |
| Labeling differences & safety | Astellas v. FDA (2009) | Minor differences OK if justified by FDA |
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