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How-to: Analyze a Pharma Company’s Decision to Use Speedier FDA Review — Classroom Exercise

iinstruction

2026-02-05

10 min read

Hands-on classroom exercise for analyzing expedited FDA review decisions—legal, commercial, and policy tradeoffs for 2026.

Hook: Turn a messy policy debate into a teachable, hands-on decision problem

Students and instructors often face the same classroom pain point: how do you turn high-level policy headlines about the FDA into a reproducible, skills-focused activity that trains students to weigh legal risk, market incentives, and strategic tradeoffs? This guided classroom exercise lets learners step into the shoes of a drug company's strategy team and decide whether to pursue an expedited review route. It combines a realistic case study, a structured risk analysis template, and clear grading rubrics so learners practice real-world pharmaceutical strategy—fast.

Executive summary (what students will learn)

In this activity, student teams will:

Apply a structured risk analysis to a pharma company's choice between standard and expedited FDA review.
Assess legal and reputational risks tied to faster review pathways and post-market commitments.
Prioritize commercial incentives (market exclusivity gains, first-mover advantage) against regulatory tradeoffs.
Draft a one-page strategy memo and defend a policy recommendation in a 10-minute oral brief.

Why this matters now (2026 context)

Late 2025 and early 2026 brought several regulatory and market shifts that make this exercise timely. The FDA and federal policymakers expanded guidance and pilot programs to shorten review timelines and encourage Real-World Evidence (RWE) use; at the same time, industry concerns over litigation and voucher-policy changes rose. As reported in January 2026, some major drugmakers are hesitating to use new speedier review options because of potential legal risks (STAT, Jan 15, 2026). This mix of faster regulatory pathways and heightened legal scrutiny creates a rich classroom environment to analyze tradeoffs.

Learning objectives (measurable)

Perform a structured legal and commercial risk assessment for an expedited FDA pathway.
Identify the key policy tradeoffs in 2026—especially RWE, AI-enabled submissions, and revised post-market commitments.
Create and defend a concise strategy memo that integrates regulatory, clinical, and market data.
Demonstrate teamwork, persuasive argumentation, and quantitative reasoning using a simple cost-benefit model.

Materials (what you need)

Instructor packet (case brief, timeline, datasets) — downloadable template recommended.
One imaginary case dossier per team (clinical trial summary, market projections, legal risk notes).
Risk matrix template (columns: likelihood, impact, mitigation, residual risk).
Simple financial calculator or spreadsheet for NPV scenarios (standard vs. expedited timelines).
Whiteboard or slide tool for team presentations.

The case: "Novella Therapeutics and the GLP-1 Analog" (fictional)

Students will use a fictionalized company to avoid proprietary or legal issues. Keep the case familiar: Novella Therapeutics has a late-stage GLP-1 analog for obesity-related indication. The molecule shows strong surrogate endpoint improvements but limited long-term safety data. The company can file for:

Standard review: Full review timeline (12–18 months), complete dataset, lower legal pressure, slower market entry.
Expedited review (Priority Review / Accelerated Approval / Breakthrough): Shorter regulatory timeline (6–9 months), conditional approval possible with post-market commitments, higher public and legal scrutiny.

Provided data (examples to include)

Phase 3 topline results: primary endpoint met (p < 0.01) vs. placebo on a surrogate biomarker; safety signal: rare pancreatitis events (0.2%).
Market model: US peak annual sales forecast $4B with expedited launch 9 months earlier, market share 25% in year 1 otherwise 12% under standard timing.
Remediation costs: expected post-market study cost $75M; additional labeling and risk mitigation $20M.
Legal scenario brief: citizen petition risk, potential class action if severe safety arises, prior precedents of lawsuits following controversial accelerated approvals.

Step-by-step classroom flow (90–120 minute session)

0–10 minutes: Setup and context

Instructor summarizes 2025–26 trends quickly: expanded RWE guidance, pilot AI review tools, and increased litigation over rapid approvals.
Distribute the Novella case packet and risk matrix template.

10–40 minutes: Team analysis

Teams map out stakeholders: patients, payers, physicians, investors, regulators, activists, and litigation risk groups.
Fill the risk matrix: estimate likelihood and impact on a 1–5 scale. Prioritize top 3 risks.
Run a quick NPV/scenario model: expedited vs. standard timing, include costs for post-market studies and potential litigation reserves.

40–60 minutes: Strategy memo drafting

Teams craft a one-page memo directed to Novella's CEO: recommendation (file expedited or standard), three supporting reasons, and two contingency plans.
Memo must include: key assumptions, top legal risk and mitigation, a simple timeline, and the break-even scenario if a safety issue causes market withdrawal.
If useful, students can use pocket edge hosts or shared templates to host interim RWE datasets for group review.

60–90 minutes: Presentations and defense

Each team gives a 7–10 minute presentation and accepts 3 minutes of Q&A from classmates acting as the Board.
Instructor grades on clarity, realism of assumptions, depth of legal risk analysis, and feasibility of mitigation strategies.

Risk analysis template (use in-class)

Have students complete this compact table for the top five risks. Use likelihood and impact scales (1 low–5 high) and then compute residual risk after mitigation.

Regulatory reversal or label change — Likelihood: 2–4 — Impact: 4 — Mitigation: enhanced RWE plan and auditability, REMS (Risk Evaluation and Mitigation Strategy).
Litigation / class action — Likelihood: 2 — Impact: 5 — Mitigation: legal reserves and litigation playbooks, robust informed consent and safety communications.
Reputational backlash and prescriber hesitancy — Likelihood: 3 — Impact: 3 — Mitigation: KOL (key opinion leader) engagement and transparent data sharing.
Commercial uptake below forecast — Likelihood: 3 — Impact: 4 — Mitigation: payer engagements, value-based contracts.
Post-market study delays / failure — Likelihood: 2 — Impact: 5 — Mitigation: outsourced CRO contingency, interim analyses.

Legal and policy tradeoffs to emphasize

Ask students to explicitly evaluate these dimensions:

Evidence standard: Accelerated Approval often relies on surrogate endpoints. Evaluate the surrogate's validity and the risk that a confirmatory trial may not replicate results.
Post-market enforcement: 2025–26 enforcement signaling has tightened; agencies are more willing to require post-approval studies and label updates quickly.
Litigation vectors: Citizens' petitions, product liability suits, securities litigation (if safety concerns trigger share drops), and False Claims Act risk if promotion exceeds approved labeling.
Policy instruments: Priority review vouchers (PRVs), orphan designations, and potential legislative changes to voucher programs—each affects the commercial calculus.
RWE and AI: Using Real-World Evidence or AI-assisted submission can speed approvals but creates scrutiny about data provenance and algorithmic transparency; teach students to interrogate provenance and model governance using edge auditability patterns.

Actionable mitigation strategies (what a company should do)

Pre-file engagement: Request early meetings with FDA (e.g., pre-IND or Type B meeting) to agree on endpoints and the acceptability of RWE or surrogate endpoints.
RWE readiness: Build a pre-specified RWE plan, including data sources, governance, and a reproducible analysis pipeline to reduce post-approval pushback.
Legal contingency planning: Create litigation playbooks, set aside reserves, and tighten clinical documentation and consent language to reduce exposure to claims; consider how solicitor automation tools can speed responses (see example).
Transparent communication: Publicly describe the evidence strengths and limitations; early KOL and patient group engagement reduces surprise and builds trust.
Payer strategies: Negotiate outcomes-based contracts anticipating safety uncertainty to protect commercial uptake in early launch phases.

Example instructor notes & model answer highlights

Below are condensed instructor notes you can adapt to any drug type. The model recommendation often depends on the weight of the safety signal vs. the market benefit. For our GLP-1 analog case:

Model answer (one plausible outcome): Recommend expedited review if the surrogate endpoint has strong epidemiological linkage to clinical benefit AND the company commits to an enforced, well-funded post-market study with pre-specified interim analyses. Rationale: substantial NPV upside from earlier market entry, manageable legal risk if mitigations are robust.
Alternative (conservative) answer: Choose standard review if the safety signal (pancreatitis) is ambiguous and the confirmatory trial is likely to alter the benefit profile—minimize legal and reputational risk.

“Some major drugmakers are hesitating to participate in the speedier review program for new medicines over possible legal risks.” — STAT, Jan 15, 2026

Assessment rubric (use for grading)

Clarity of recommendation (20%): Is the recommendation unambiguous and well-justified?
Depth of risk analysis (25%): Did the team identify and quantify legal and clinical risks appropriately?
Feasibility of mitigation (20%): Are the proposed mitigations practical and timely?
Quantitative reasoning (15%): Is the NPV or break-even modeling credible and transparent?
Presentation & defense (20%): Persuasiveness, ability to answer tough questions, and teamwork.

Extensions for advanced classes or multi-session modules

Legal lab: Have students draft a short legal memo outlining probable causes of action and sample discovery requests.
Data lab: Provide raw trial data and ask students to run ad hoc safety analyses; compare frequentist and Bayesian interpretations.
Policy debate: Stage a mock FDA Advisory Committee with advocacy groups, payers, and clinicians as stakeholders.
Stakeholder simulation: Add investor and activist investor roles that can pressure the company during the decision.

Teaching tips to maximize learning

Keep the timeline tight—90 minutes encourages focused analysis rather than overfitting to minor evidence.
Encourage teams to state their top three assumptions explicitly; this makes disagreements tractable and assessment objective.
Use a single spreadsheet template with locked formulas so assessment focuses on assumptions not spreadsheet skills; consider collaborative tools and edge-assisted collaboration to speed reviews.
Bring in a guest (regulatory lawyer, former FDA reviewer, or industry strategist) for critique if possible—real-world feedback increases engagement.

Common student pitfalls and how to correct them

Pitfall: Overconfidence in surrogate endpoints. Correction: Force a sensitivity analysis where surrogate-clinical correlation is weaker.
Pitfall: Ignoring legal costs. Correction: Require teams include a legal reserve estimate and rationale.
Pitfall: Confusing probability and impact. Correction: Use explicit scales and ask teams to justify Likelihood & Impact numerically.

Real-world signals to watch (2026+)

To bring current events into subsequent classes, track these developments in 2026:

FDA enforcement actions on post-market study failures and labeling changes.
Major litigation outcomes against drugs approved via expedited pathways—these cases shape industry risk models.
Policy debates over priority review vouchers and whether Congress modifies or extends voucher programs.
Adoption and oversight of AI tools in regulatory review—transparency requirements will affect evidence packages.

Takeaways for students (what to remember)

Tradeoffs are multidimensional: Faster market access increases commercial upside but raises legal and evidentiary risk.
Mitigation matters: A credible RWE plan, transparent communications, and legal preparedness can tilt the risk-reward in favor of expedited review.
Assumptions drive decisions: Be explicit about surrogate validity, litigation likelihood, and payer behavior in your models.
Policy context changes rapidly: 2025–26 trends (RWE, AI tools, voucher debates) should be periodically reassessed in real-world cases.

Optional downloadable instructor checklist

One-page case brief (editable)
Risk matrix and scoring spreadsheet
Presentation scoring sheet
Model answer and instructor notes

Final classroom-ready sample prompt (copy-paste)

“Novella Therapeutics must decide whether to seek an expedited FDA review for its GLP-1 analog. Using the provided trial data and market model, prepare a one-page memo recommending ‘Expedited’ or ‘Standard’ review. Include a risk matrix for your top five risks, an NPV comparison, and two contingency plans. Present and defend your recommendation in 7 minutes.”

Closing: Why this exercise builds professional judgment

This activity trains students to synthesize clinical, regulatory, legal, and commercial factors—exactly the cross-functional judgement required in real-world pharmaceutical strategy. By combining a concise decision framework with current 2025–26 regulatory trends (including RWE, AI, and heightened litigation scrutiny), your students will practice making faster, better-documented choices. They’ll also learn to communicate tradeoffs clearly—an essential skill for policy debates and boardroom decisions.

Call to action

Try this exercise in your next class. Download the instructor packet, adapt the case to your curriculum, and share student memos with us for feedback. Want a premade spreadsheet and model answer? Contact our education team to get the full instructor kit and start running this activity in under 30 minutes.

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