Center for Drug Evaluation and Research (CDER) processes
Center for Drug Evaluation and Research (CDER) Processes
CDER’s primary role is to ensure that drugs marketed in the U.S. are safe and effective for their intended use. The process involves:
Preclinical Research: Before human trials, drug sponsors conduct lab and animal testing.
Investigational New Drug (IND) Application: Sponsor submits an IND to CDER to begin clinical trials.
Clinical Trials: Human testing in phases (I to III) to evaluate safety, dosage, efficacy, and side effects.
New Drug Application (NDA): After trials, the sponsor submits an NDA for CDER review.
Review Process: CDER reviews clinical data, manufacturing info, labeling, and risk-benefit analysis.
Approval or Denial: CDER approves if benefits outweigh risks; otherwise, it may refuse or request more data.
Post-Marketing Surveillance: Ongoing monitoring of drug safety once on the market.
Case 1: FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000)
Context: The FDA attempted to regulate tobacco as a drug under the FDCA.
Ruling: The U.S. Supreme Court held that CDER did not have authority to regulate tobacco as a drug because Congress had explicitly excluded tobacco.
Significance: Defined limits of CDER’s regulatory jurisdiction.
Takeaway: CDER’s authority is bound by Congressional mandates; it cannot overextend regulatory reach without explicit legislative support.
Case 2: Wyeth v. Levine, 555 U.S. 555 (2009)
Context: A patient sued Wyeth for inadequate warning labels on a drug approved by CDER.
Ruling: The Supreme Court held that FDA approval of labeling does not preempt state-law claims of inadequate warnings.
Significance: Demonstrated the interaction between CDER’s regulatory decisions and tort law.
Takeaway: CDER approval does not shield manufacturers from liability under state law for insufficient warnings.
Case 3: FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000)
Context: Reiterating CDER’s regulatory limits, this case highlighted the necessity of clear statutory authority for CDER’s actions.
Ruling: FDA lacked authority to regulate tobacco as a drug without Congressional approval.
Significance: Affirmed the need for explicit legislative guidance for CDER regulation expansion.
Takeaway: CDER’s role is confined to drugs explicitly within FDA jurisdiction.
Case 4: Alliance for Natural Health USA v. Sebelius, 775 F. Supp. 2d 114 (D.D.C. 2011)
Context: Challenge to CDER’s regulation of dietary supplements and health claims.
Ruling: The court upheld CDER’s authority to regulate health claims on dietary supplements to protect public health.
Significance: Affirmed CDER’s oversight role extends to claims that could mislead consumers.
Takeaway: CDER can regulate not just drugs but also related claims to ensure truthfulness.
Case 5: Pfizer, Inc. v. FDA, 430 F.3d 1348 (Fed. Cir. 2005)
Context: Pfizer challenged CDER’s refusal to approve a drug application based on safety concerns.
Ruling: The court deferred to CDER’s scientific judgment, affirming that the FDA’s expertise is entitled to deference.
Significance: Reinforced the principle that courts respect CDER’s expertise in drug evaluation.
Takeaway: Judicial review of CDER decisions is deferential, focusing on procedural fairness and reasonableness.
Summary Table:
| Case | Issue Addressed | Legal Principle | Impact on CDER Processes |
|---|---|---|---|
| FDA v. Brown & Williamson (2000) | CDER’s regulatory jurisdiction | Limits on regulatory authority without Congress | Clarified CDER’s statutory boundaries |
| Wyeth v. Levine (2009) | Labeling and preemption | FDA approval does not preempt state tort claims | CDER approval not absolute shield against liability |
| Alliance for Natural Health v. Sebelius (2011) | Regulation of health claims | CDER’s authority to regulate supplement claims | Expanded CDER oversight of consumer information |
| Pfizer v. FDA (2005) | Judicial review of approval | Courts defer to CDER’s scientific expertise | Reinforced deference to CDER decisions |
Additional Notes:
CDER’s regulatory decisions must be based on scientific evidence and follow strict procedural requirements.
Judicial review of CDER decisions usually focuses on whether the agency acted arbitrarily or capriciously.
Interactions with other laws: CDER’s authority intersects with state laws and other federal statutes.
Post-market surveillance is critical to CDER’s ongoing evaluation of drug safety.
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