Center for Biologics Evaluation and Research (CBER) approvals
Overview: Center for Biologics Evaluation and Research (CBER)
CBER is a branch of the U.S. Food and Drug Administration (FDA) responsible for regulating biological products, including vaccines, blood products, cellular and gene therapies, and other biologics. The core responsibilities include:
Review and approval of biological products for safety, purity, and effectiveness.
Regulation under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act (FDCA).
Oversight of licensing of biological products (Biologics License Applications or BLAs).
Monitoring post-market safety.
CBER’s approval process involves scientific review, clinical trials evaluation, and manufacturing inspections before licensure.
Key Regulatory Framework
Biologics License Application (BLA): Applicants must demonstrate safety, purity, potency, and manufacturing quality.
Clinical Trials: Pre-market testing, including Phase I-III trials, is reviewed by CBER.
Post-approval: Ongoing monitoring for adverse events.
Important Case Law on CBER Approvals
1. FDA v. Brown & Williamson Tobacco Corp. (2000)
Facts: Although this case mainly involved FDA’s regulatory authority over tobacco, it’s important for FDA’s jurisdiction over products.
Issue: Whether the FDA had authority to regulate tobacco products under the FDCA.
Ruling: The Supreme Court ruled that FDA lacked authority to regulate tobacco as a drug or device without explicit congressional authorization.
Significance for CBER: Clarifies that FDA (and by extension CBER) authority to regulate biologics depends on statutory mandate. It underscores limits of FDA’s jurisdiction and regulatory power, including biologics.
2. Kirin-Amgen, Inc. v. Hoechst Marion Roussel, Inc. (2004)
Facts: The case concerned patent rights on biologics and issues related to FDA approval.
Issue: The intersection of FDA approval and patent law, including exclusivity for biological products.
Ruling: The court recognized that FDA licensure creates regulatory exclusivity impacting market competition.
Significance: Highlights how CBER approvals interact with intellectual property law, affecting biologics market entry and innovation.
3. Sandoz Inc. v. FDA (2018)
Facts: Sandoz submitted a biosimilar application to FDA under the Biologics Price Competition and Innovation Act (BPCIA), with CBER involvement.
Issue: Legal questions about timing and disclosure requirements during biosimilar approval.
Ruling: The court clarified procedural requirements for biosimilar approvals, including FDA’s role in disclosure between parties.
Significance: Emphasizes CBER’s regulatory role in biosimilar approval, balancing innovation with competition.
4. Washington Legal Foundation v. Henney (1999)
Facts: The case challenged FDA’s authority over off-label uses of approved biologics and drugs.
Issue: Whether FDA (and by extension CBER) can restrict dissemination of off-label promotion information.
Ruling: The court upheld FDA’s regulatory authority but emphasized First Amendment protections, limiting FDA’s ability to restrict truthful, non-misleading information.
Significance: This case limits the extent of CBER’s control post-approval, particularly concerning communications about biologics.
5. Cutler v. Hayes (1987)
Facts: A challenge to FDA’s delay in approving a biological drug.
Issue: Whether courts can compel FDA (and CBER) to act on approval applications within a certain time.
Ruling: The court acknowledged FDA’s discretion but also that undue delay can be challenged under the APA.
Significance: Establishes that agency approval decisions are reviewable for unreasonable delay, balancing agency discretion and applicants’ rights.
Summary of Key Themes from Cases
| Theme | Explanation | Case Example |
|---|---|---|
| Statutory Authority Limits | FDA/CBER authority is defined strictly by statutes; limits on regulatory reach exist. | FDA v. Brown & Williamson |
| Regulatory Exclusivity | Approval by CBER grants exclusivity impacting patents and competition in biologics markets. | Kirin-Amgen v. Hoechst |
| Biosimilar Approval Procedures | CBER regulates biosimilar pathways, balancing innovation and public access. | Sandoz v. FDA |
| Post-Approval Communications | CBER’s regulatory scope on off-label promotion is limited by free speech protections. | Washington Legal Foundation v. Henney |
| Reviewability of Delays | Courts may review agency delays but respect scientific discretion. | Cutler v. Hayes |
Practical Implications
CBER’s approval process is highly scientific and evidence-driven but occurs within clear statutory limits.
Courts tend to defer to CBER’s expertise but provide remedies against undue delays.
Regulatory exclusivities granted through CBER licensure influence market dynamics and patent disputes.
Post-approval, CBER’s enforcement powers are balanced against constitutional rights like free speech.
The approval of biosimilars has become a critical area involving complex statutory interpretation and procedural rigor.
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