For most of the past decade, biotech and biopharma companies could run pricing strategy and regulatory strategy as parallel tracks that occasionally crossed. The ground has shifted; that era is over.

The Trump administration’s Most Favored Nation executive order (EO 14297, signed May 12, 2025), coupled with the destabilization of FDA’s review infrastructure, have created a convergent shock for the industry. This dual disruption is now reshaping revenue models, launch architectures, investor confidence and the communications frameworks companies rely on to build and maintain public trust.

The policy negotiation table, the earnings call, the KOL advisory board and the FDA pre-submission meeting are no longer separate conversations. They are cornerstones of a single strategic narrative.

Every biopharma company — whether U.S. or non-U.S. domiciled — with a late-stage asset, near-term launch, or revenue-bearing product has decisions to make that its legacy playbooks will not adequately address. The companies that emerge with a competitive advantage will be those that treat communications and government affairs as core strategy, not as downstream outputs.

The November 2026 midterm elections have the potential to reshape Congressional priorities and the White House’s negotiating leverage on drug pricing. Before then, the administration has every incentive to push bilateral deals, onshoring commitments and MFN implementation forward — and companies that are not positioned will be negotiated around, not with.

The period between now and November is not a pause but a structural reset. Companies that plan and act based upon considered evaluations will shape outcomes; those that wait will be shaped by them. Leaders should focus on five priorities:

1. Pressure-test your financial and commercial model — and communicate it clearly

• Scenario-plan MFN exposure (best/base/worst) and translate each into credible, investor-ready narratives.
• Assess tariff, pricing and onshoring implications now and continue those evaluations as new announcements emerge. The Department of Commerce deadline for onshoring applications (June 12, 2026) is not a soft deadline, and Section 232 tariffs of up to 100% on patented pharmaceuticals take effect at the end of July. Companies that enter both onshoring and MFN pricing agreements face a 0% tariff, while onshoring alone nets a 20% rate. That math needs to be factored into your decision making at the board level.
• Treat this as a market-facing exercise, not an internal one. The market is already pricing in risk.

2. Re-engineer launch and regulatory strategy for volatility

• Conduct an integrated review of all assets within ~24 months of U.S. approval, explicitly modeling MFN-driven ex-U.S. sequencing impacts.
• Stress-test your FDA engagement with built-in contingencies for delays, complete response letters and leadership changes at relevant review divisions.
• Communicate milestones with disciplined flexibility, preserving confidence in science while managing expectations on timing.

3. Proactively shape the policy and regulatory environment

• Engage now in PDUFA VIII negotiations. FDA must deliver final recommendations to Congress by January 15, 2027, meaning the window to shape terms such as performance commitments, CMC engagement structures and fee frameworks for the next several years is closing fast. If your company’s pipeline includes rare disease, cell and gene therapies or novel modalities, your interests are directly at stake, and your voice needs to be in the room.
• Define your position on trade and pricing, aligning it across government affairs, communications and coalition participation. Congress will want to put its stamp on the agreement; let it reflect your stamp too.
• Ensure your voice is accurately reflected in the trade groups and coalitions influencing policy outcomes — PhRMA, BIO, the Alliance for Regenerative Medicine, EFPIA and disease-area coalitions.

4. Build independent credibility beyond regulatory approval

• Strengthen the scientific and clinical narrative through KOLs, publications, medical societies and patient communities.
• Do not rely on FDA approval as the sole validator. Create durable, external proof points that stand on their own and be routinely updated based on ongoing data collection.

5. Align leadership, narratives and geopolitical strategy

• Integrate government affairs and communications at the leadership level; this intersection is now a core business driver, not just a support function.
• For non-U.S. companies, activate home governments as diplomatic assets and build a visible U.S. manufacturing and investment narrative. The UK–U.S. pharmaceutical pricing arrangement is the model for what sovereign-level engagement can achieve.
• Manage a dual story rooted in global identity and credible U.S. commitments. Both aspects matter in D.C.-based negotiations and in global capital markets.

This is not a moment for incremental adjustments. It is a moment for integrated strategic transformation.

The companies managing this environment most effectively share four characteristics: they have closed the gap between policy intelligence and communications planning; they have elevated government affairs from a support function to a revenue-critical capability; they have built integrated scenario playbooks rather than reactive response trees; and they have invested in executive communication capability that operate simultaneously in Washington, in home capitals and in global capital markets.

The MFN–FDA convergence is not a temporary disruption. It is the new operating environment. Whether you are a U.S.-headquartered biotech navigating a Series C or a European pharma giant managing a bilateral deal with the White House, the strategic imperatives are converging.

RC Resolve works at exactly this intersection — bringing policy, public affairs, government affairs, regulatory intelligence, financial communications and issues management into the integrated capability this moment demands.

November is not a deadline. It’s a horizon. And the ground between here and there is already shifting.

– Bridget Walsh, Head of Policy, Public Affairs and Access, RC Resolve