In yet another FDA transition, Dr. Marty Makary is out after just 13 months at the agency. Top food regulator Kyle Diamantas is stepping in as acting commissioner while the White House looks for a permanent replacement – a process that could take months.

For drugmakers, the issue is not just who comes next. It’s what interim leadership means for regulatory consistency, especially for companies with late-stage programs or submissions on deck.

Some of the review acceleration efforts advanced during Makary’s tenure were never formalized through rulemaking, which means they may prove less permanent than many hoped. This inflection point is a good time to revisit assumptions and ensure regulatory strategy reflects the FDA’s current posture, not the version of the agency teams may have been planning around earlier this year.

The rapidly evolving agency leadership over the past year highlights the importance of staying close with review divisions and remaining career staff. Leadership at the top can shape priorities, but day-to-day continuity tends to live deeper in the agency. For companies trying to keep programs on track, those relationships matter more than ever.

This is also a reminder not to think about FDA strategy in isolation. Regulatory alignment across major agencies continues to move forward, including recent FDA-EMA work on principles for AI in drug development. Meanwhile, regulators including the EMA and MHRA are continuing to lean into tools such as rolling reviews and adaptive pathways. For companies with global programs, a stronger cross-border evidence strategy can help reduce dependence on any one regulator’s posture and maintain more flexibility if expectations shift.

Until a new commissioner is named, companies in the best position may be the ones that stay close to the agency’s operational core and use this moment to pressure-test both their U.S. and global regulatory strategies.

– Leslie Isenegger, Head of Growth & Strategy, RC Resolve

RC Resolve, Real Chemistry’s corporate affairs advisory, provides end-to-end strategy through execution to help healthcare organizations navigate complex business challenges, policy issues and reputational risk.

Anyone looking for hard-hitting policy insights during earnings calls was left somewhat disappointed when Q1 2026 calls wrapped up this week.

It seems no news is good news. Overall, the industry appears to have largely weathered some of the top concerns of 2025 – tariffs, most favored nation pricing and regulatory upheaval – without much impact. Expanding markets for GLP-1s via the Medicare Bridge Program also provided a hopeful outlook for the likes of Eli Lilly and Novo Nordisk.

For the most part, sales are up and companies are finding their way in the new frontier. However, a few universal concerns have emerged across leaders’ remarks:

Impact of the Inflation Reduction Act

Multiple manufacturers, including Amgen and AbbVie, noted that the IRA negatively impacted their Q1 sales. Many others, including Novartis, Astellas and Teva, anticipate revenue loss when lower negotiated prices go into effect under the next waves of drugs in 2027 and 2028. Companies are looking to offset losses where possible.

Mid-Size Worries about MFN

While many large pharma companies have been able to mitigate impacts of MFN, mid-sized companies have not been so fortunate. During his earnings remarks, Insmed CEO Will Lewis said MFN had caused the company to pause launch efforts in Europe and the UK, noting a lack of bargaining power. Lewis didn’t mince words: “The result of MFN will be to bankroll the Chinese biotech market, which I don’t think is really in anyone’s interest.”

Geopolitical Instability and Conflict

As the war in Iran continues and the Strait of Hormuz remains inaccessible, the industry braces itself for potential challenges in manufacturing and shipping in subsequent quarters. Regional manufacturers, such as Teva, have felt nominal increases in transportation and energy costs. But analysts are closely watching the macro-level impacts of prolonged conflict on companies’ bottom lines.

– Rachel Bridges, Senior Director

UnitedHealth Group’s pharmacy benefit manager, Optum Rx, debuted changes to its model that would provide greater transparency to members.

In an official announcement this week, Optum said that, beginning in 2027, it will charge employers clear monthly fees that are not based on drug list prices or prescription volume. It will also eliminate spread pricing, a practice in which PBMs charge health plans more than they reimburse pharmacies and pocket the difference.

Among additional efforts to boost transparency, Optum said it plans to pass through 100% of discounts it negotiates from drugmakers and provide members with the ability to audit rebates and fees all the way back to their group purchasing organization. The GPO would transition to flat service fees by the end of 2027.

Despite these changes, critics question whether Optum’s moves toward greater transparency will meaningfully lower pharmacy costs for customers – or whether it is part of a broader move to outpace government action against them. In recent years, PBMs have faced increasing external pressure, including being subject to an FTC lawsuit and repeatedly drawing scorn from lawmakers and the White House.

Despite these concerns, the stakeholders set to benefit from the transparency appear to support it. A recent survey from the Penta Group found that employers want greater transparency in their pharmacy benefits, with many viewing a model without rebates as an effective way to get there.

Optum’s peer, Express Scripts, also plans to roll out a more transparent benefits model in 2027. As such, the winds of change in the pharmacy benefit industry are afoot; only time will tell, however, whether these changes lead to greater benefit for patients.

– Matthew Peacock, Senior Manager

• May 17-20 – annual meeting for all things Health Economics and Outcomes Research, ISPOR 2026

• “Makary’s failures were as much a product of the pressures baked into the Trump administration and Kennedy’s MAHA movement as they were his inability to navigate them.” – Drew Armstrong, Endpoints
• “Redirecting patients away from medications is only clinically responsible if the alternatives are accessible. They are not.” – Dr. Jonathan Slater, STAT
• “Each year, approximately 2 million osteoporosis-related fractures occur in the U.S. with more than 400,000 of them resulting in hospitalization…Yet osteoporosis remains a widely underestimated condition and is often considered ‘just another part of aging.’” – Christen Buseman, LinkedIn
• “The Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices were supposed to be the firewall. They have become talking points.” – Dr. Robert B. Shpiner, The Hill

• The Commerce Department outlined a formal process for pharma companies to apply for onshoring agreements that would reduce Section 232 tariffs from 100% to 20%. Pink Sheet: Pharma Onshoring Agreements Would Include Stiff Tariff Penalties, Import Scrutiny.
• The Supreme Court blocked a Fifth Circuit ruling that would have restricted nationwide mail access to the widely used abortion medication mifepristone, keeping telehealth prescriptions available while litigation continues. The New York Times: Supreme Court Allows Abortion Pill Access by Mail to Continue.
• Germany’s ruling coalition is advancing legislation to increase mandatory drug rebates, garnering swift backlash and warnings that the country’s pharmaceutical industry will deteriorate. Bloomberg: Germany’s Healthcare Reforms Herald More Pain for Big Pharma.
• As the Iran war enters its third month, upstream pharma supply chain disruptions are emerging through rising energy and shipping costs. Endpoints: Iran war disruptions begin to emerge upstream of the pharma supply chain.
• The FDA is seeking input on repurposing approved drugs for new uses in an effort to improve treatment availability using existing scientific data. Reuters: US FDA mulls repurposing approved drugs to expand access.
• Trump’s 17-member business delegation to Beijing was notably missing biopharma representation, reflecting a growing tension between U.S. wariness of China’s biotech influence and the industry’s race to leverage Chinese innovation. Fierce Pharma: As Trump arrives in China, Big Pharma CEOs are notably absent.
• Medicare spending on Alzheimer’s drugs Leqembi and Kisunla has come in dramatically below projections, with complicated administration requirements and a limited eligible patient population stunting uptake. STAT: Medicare is spending far less than expected on new Alzheimer’s drugs.
• A March data breach targeting RXNT, a medical software provider used by the congressional medical office, compromised the prescription histories and personal information of members of Congress. Politico: Lawmakers’ prescription data at risk after data breach.