6-Month Check-up: Navigating a Healthcare Policy Landscape in Flux

As we reach the halfway mark of 2025, one thing is clear: the healthcare policy environment is changing fast. While themes like drug pricing and regulatory reform remain familiar, the pace, volume, and complexity are unprecedented. For biopharma, MedTech, and nonprofit healthcare organizations, public policy is no longer something to watch passively—it’s something to be managed proactively. 

Here’s a snapshot of the latest executive actions, federal agency activities, and legislative developments on Capitol Hill. 

Executive Orders: Deregulation, Drug Pricing, and Supply Chain Shakeups 

More than a dozen executive orders have already touched healthcare, well above the norm for this point in the year. The themes: deregulation, domestic production, and pricing pressure. 

• Most Favored Nation: The return of MFN directs HHS to push drugmakers to match the lowest prices they offer in developed countries. While framed as voluntary, the order outlines consequences, including rulemaking, importation, and trade actions, if companies fail to comply.  

• Tariffs: A broader tariff strategy now targets APIs, syringes, and diagnostic tools. The goal is to boost U.S. manufacturing, but it also introduces uncertainty for global sourcing and pricing. 

• Transparency: Directives have ramped up enforcement of hospital and insurer price transparency, calling for changes to site-neutral payments, 340B oversight, and Medicaid block grant flexibility. 

• 10-for-1 Rule: The most sweeping order yet mandates the repeal of ten regulations for every new one introduced—rules, guidances, and internal policies alike. OMB now has broad authority to enforce cuts, putting pressure on HHS, FDA, and CMS to scale back in areas like digital health, postmarket surveillance, and environmental compliance.

Regulators: Fewer Staff, Bigger Shifts, and AI Hype 

Inside HHS and its sub-agencies, structural and strategic changes are reshaping how policy is developed and enforced. 

• Workforce Cuts: Widespread role eliminations through cuts and voluntary leave measures have swept across NIH, CMS, and FDA, straining review timelines and engagement capacity. 

• MAHA Commission: The Make America Healthy Again Commission reached its milestone of publishing a report focused on reshaping federal priorities around fertility, pediatrics, and rare diseases. Its blueprint is already influencing CMS pilots and NIH grantmaking. 

• FDA Listening Tour: FDA Commissioner Marty Makary began his roadshow by hearing directly from pharmaceutical and biotech industry leaders about how the agency can modernize its regulatory framework to better support innovation and increase patient access to treatments.  

• Elsa, FDA’s AI Tool: Touted as transformational, Elsa is designed to streamline FDA operations by summarizing safety reports and protocols. However, its current use remains administrative—drafts, notes, and internal summaries—and some companies are raising concerns about security and requesting opt-outs for proprietary data. 

• User Fee Reauthorization (PDUFA VIII): Quiet conversations are already underway around AI readiness, performance metrics, and accelerated approval. Stakeholders should begin shaping their positions now, as waiting for formal negotiations may be too late. 

Capitol Hill: Drug Pricing Dominates, with PBMs and Penalties in Focus 

While partisan noise remains high, Congress is showing rare bipartisan interest in cost and access issues. 

• PBM Reform: Multiple bills would ban spread pricing, boost transparency, and require PBMs to act in clients’ best interests. A consolidated package could advance later this year. 

• The “Pill Penalty”: Lawmakers are considering inflationary penalties for price increases beyond Medicare, and some even suggest retroactive enforcement based on 2024 data. 

• 340B & Site-Neutrality: Momentum is building for reforms around program eligibility and payment parity despite pushback from hospital systems. 

• MedTech Reimbursement Reform: Recently reintroduced legislation would close the long-standing gap between FDA approval and Medicare coverage for innovative medical devices. The bill would accelerate access for seniors and modernize how CMS evaluates breakthrough technologies, bringing payment timelines closer in line with innovation cycles.

What’s Ahead 

Here’s what we’re watching for the second half of 2025: 

• Regulatory Rollbacks: Agencies will begin publishing repeal candidates under the 10-for-1 directive. Expect a focus on guidances from the past five years. 

• AI Guardrails: Companies may see more clarity—or new limits—on how FDA’s AI tools interact with their data. Transparency and security will be key flashpoints. 

• User Fee Negotiations: It’s time to prepare internally. Decisions about what to prioritize—or resist—should be made now, not when the window formally opens. 

• MAHA Commission Recommendations: The Commission set an 82-day deadline—around August 12—to release specific policy proposals under its Make Our Children Healthy Again strategy. 

• More Executive Orders: Stay tuned for new directives around health benefit design, transparency, and federal purchasing strategies.  

Let’s Talk.

Whether you’re preparing for user fee talks, pushing PBM reform, or shaping your policy engagement strategy, we’re here to help. 

Rachel Gartner Clark is a Managing Director at Narrative, bringing over fifteen years of experience in healthcare public affairs. Rachel was previously a Senior Group Director at Real Chemistry, spearheading its public affairs offering. Want to continue the conversation? Email me directly at rclark@narrativestrategies.com.