Biopharma in Flux: How to Lead Through 2025's Regulatory Whirlwind

Hannah Dersiewicz | EVP, Managing Director, Investor Relations & External Communications
Greg Gregory, PhD | EVP, Partner
Ross Maclean | EVP, Head of Medical Affairs
Harpreet Singh, MD | Chief Medical Officer, Precision for Medicine

The first half of 2025 has seen significant uncertainty in the US biopharmaceutical market as regulatory processes and the access and reimbursement environment have changed under the new Administration:

• Regulatory agency staff and leadership are in transition – This year, an estimated 3,500 FDA staff will depart, with consequent implications for safety inspections around the globe and delays in new product reviews (1). Recently, the biotech company KalVista noted that regulatory overload may have contributed to a delay in a drug approval decision for their new treatment for HAE (2). Adding to the shakeup, the director of the FDA’s Office of Therapeutic Products (CBER) and her deputy were placed on administrative leave in mid-June 2025—an abrupt move that’s raised concerns around leadership continuity in cell and gene therapy regulation.

• Regulatory and public health advisory committees are being restructured – In addition to the much-publicized cuts to the CDC’s Advisory Committee on Immunization Practices (ACIP), the CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC)—a group that has been in place for over 30 years—has been disbanded (3).

• Changes to public insurance programs impacting coverage and work requirements – This includes (i) a proposition to cut as much as $715 billion from Medicaid (per a CBO estimate), which would increase the number of uninsured (4), and (ii) implementing the much-debated topic of requiring Medicaid recipients to be in some form of paid work or to have attempted to find work (5).

As this article was going to press, further significant changes are under discussion:

• Global drug pricing benchmarks such as ‘Most Favored Nation’ are being considered – A move that would peg US drug prices to the lowest paid by comparable countries (6). Recently, Dr. Albert Bourla, CEO of Pfizer, noted that some pharma companies are coming together to create a unified front in MFN discussions with the US government, commenting that “discussions are still at an early stage” (7).

• Greater transparency in drug pricing – The bipartisan ‘Drug-price Transparency for Consumers Act of 2025’ has been introduced, which would require drug companies to include the list price of prescription drugs in all direct-to-consumer (DTC) advertisements (8).

• FDA Commissioner’s rapid ‘National Priority Voucher (NPV) program’ – A novel initiative that aims to “shorten review time from approximately 10–12 months to 1–2 months following a sponsor’s final drug application submission” (9).

Amid such a dynamic environment, there is a natural reaction across the biopharma sector that “we have to respond right away,” resulting in a tendency to chase the topic of the day, establish ‘task forces,’ and—at the most extreme—introduce changes to company strategy, all raising the workload and stress level within the organization.

We would argue that five leadership behaviors—all rooted in advance planning and strong fundamentals—can reduce these uncertainties and better position biopharma companies to manage through challenging and dynamic environments:

1. Scenario planning – Identify the best, likely, and worst-case scenarios with ‘wild card’ options related to critical path tactics. Validate assumptions with appropriate internal and external perspectives.

2. Risk mitigation tactics – Identify and map the tactics that can be initiated to overcome the different scenarios at a practical, granular level, with resources secured to support the work.

3. Clinical, regulatory, and launch preparation metrics – Ensure meticulous project management that accommodates multiple, diverse inputs and guides decision-making for each scenario and mitigation tactic.

4. Capital expenditure gating – Align operational considerations with financial resources and constraints in order to deliver fiscally prudent budget management.

5. Communication planning with external stakeholders and investors – Ensure relevant stakeholders are kept in the loop regarding plans, mitigation tactics, critical business decisions, and financial implications.

A trusted partner can support each of the above activities; however, multiple siloed advisors and consultants can further exacerbate the tension, forcing the biopharma firm’s staff to “connect the dots.”

If you are losing sleep over any of the above and seek comprehensive, coordinated, and insightful guidance, call us.

Avoid These Common Planning Traps:

• • Chasing headlines without anchoring to business impact
  • Planning silos (e.g., market access, regulatory, medical, brand, etc.)
  • Underinvesting in payer-specific scenario modeling
  • Assuming historical timelines still apply (to you or your competitors)
  • Reacting instead of proactively engaging key accounts/customers

References: 

1. https://www.brookings.edu/articles/the-trump-administrations-nih-and-fda-cuts-will-negatively-impact-patients/ Published May 14, 2025, accessed June 18, 2025
2. https://www.fiercebiotech.com/biotech/fdas-heavy-workload-blamed-delays-kalvistas-angioedema-drug-approval-decision/ Published June 16, 2025, accessed June 18, 2025.
3. https://globalbiodefense.com/2025/05/07/the-disbanding-of-hicpac-is-part-of-a-larger-dangerous-pattern-of-undermining-health-protections/ Published May 7, 2025, accessed June 18, 2025.
4. https://www.cbpp.org/research/health/house-republican-bill-would-cut-medicaid-funding-to-states-providing-own-health Published May 19, 2025, accessed June 18, 2025.
5. https://www.kff.org/medicaid/issue-brief/5-key-facts-about-medicaid-work-requirements/ Published February 18, 2025, accessed June 18, 2025.
6. https://schaeffer.usc.edu/research/most-favored-nation-drug-pricing-has-three-significant-problems/ Published April 14, 2025, accessed June 18, 2025.
7. https://pharmadispatch.com/news/pfizer-chief-sets-out-the-potential-implications-of-most-favored-naton-pricing Published June 11, 2025, accessed June 18, 2025.
8. https://taylor.house.gov/media/press-releases/congressman-taylor-introduces-bill-requiring-price-transparency-prescription Published June 5, 2025, accessed June 18, 2025.
9. https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests Published June 17, 2025, accessed June 18, 2025.