The most consequential week in biopharma this year ends with two developments that signal where the industry’s power structures are shifting. PhRMA CEO Steve Ubl announced he will step down at the end of 2026 after more than a decade leading the brand drug industry’s main lobbying organization—the longest tenure in PhRMA’s 68-year history. His departure comes as the trade group’s institutional model has been systematically undermined by an administration that prefers negotiating pricing and tariff deals directly with individual company CEOs. Sixteen of seventeen major drugmakers signed MFN agreements without PhRMA’s involvement. Meanwhile, the FDA released its FY2027 budget request at $7.2 billion, which includes the most structurally ambitious regulatory reform proposal in years: an Expedited IND pathway that would allow Phase 1 trials to begin using non-animal preclinical data, explicitly framed as a competitive response to China’s faster regulatory timelines. This caps a week that delivered Foundayo’s approval, Section 232 tariffs, $8 billion in new M&A, Sanofi’s mixed lunsekimig data, AbbVie’s 86% Humira discount, a contracting global pipeline, and Anthropic’s $400 million biotech AI acquisition.
Top Story: PhRMA’s Longest-Serving CEO Is Stepping Down
What Happened: Steve Ubl announced on April 8 that he will step down as president and CEO of PhRMA at the end of 2026. The board, chaired by Merck CEO Rob Davis, has begun a search for his successor. Ubl will remain until a replacement is appointed.
A Decade of Navigating the Industry’s Biggest Battles
Ubl led PhRMA through an extraordinary period of policy upheaval. His tenure spanned the COVID-19 pandemic—during which the pharmaceutical industry’s public standing reached historic highs—the passage of the Inflation Reduction Act, which enabled Medicare drug price negotiation over PhRMA’s strenuous objections, and the Trump administration’s escalating campaign of MFN pricing agreements and Section 232 tariffs. Under Ubl’s leadership, PhRMA expanded its focus beyond traditional lobbying to include campaigns targeting pharmacy benefit managers, defense of the 340B drug discount program, and the addition of major members including Gilead and Genentech. PhRMA spent nearly $38 million on lobbying in 2025, the highest amount on record.
Why the Timing Matters
Ubl is leaving as PhRMA’s institutional model faces a fundamental challenge. The trade group’s value proposition has always been collective bargaining power—representing brand drugmakers as a unified voice in Washington, pooling resources for lobbying, legal challenges, and public campaigns. That model works when the government engages with the industry collectively. It breaks down when the White House negotiates one CEO at a time.
The Trump administration’s approach has systematically bypassed PhRMA. MFN pricing deals were negotiated company by company. Section 232 tariff exemptions are granted company by company. TrumpRx listings happen company by company. In each case, the incentive for individual companies is to cooperate directly with the administration rather than coordinate through PhRMA. Sixteen of the seventeen largest drugmakers signed MFN agreements without PhRMA’s involvement. PhRMA publicly distanced itself from those deals, but the result was the same: the collective voice was sidelined by bilateral negotiation.
Axios reported that PhRMA lobbyists have expressed frustration at the organization’s declining influence. The Washington Post called Ubl “Washington’s most powerful drug industry lobbyist.” The gap between that description and the reality of how drug pricing policy has been made over the past year tells you everything about why the departure is happening now.
What Ubl’s Successor Inherits
Whoever replaces Ubl inherits an organization searching for relevance in a policy environment that has structurally shifted toward bilateral engagement. The new CEO will need to answer a fundamental question: what is PhRMA’s value proposition when the biggest companies can get better deals by negotiating alone?
The options are not obvious. PhRMA could reinvent itself as a policy research body, providing data and analysis that individual companies lack the resources to produce independently. It could pivot to an industry convener role, facilitating coordination on non-pricing issues like supply chain resilience, workforce development, and regulatory harmonization. It could focus its advocacy on mid-sized biotechs that lack the leverage to negotiate individually with the White House—the exact companies most exposed to Section 232 tariffs. Or it could double down on collective lobbying and hope that a future administration returns to institutional engagement. None of these paths is easy, and the record $38 million lobbying spend in 2025 suggests the current approach is producing diminishing returns.
Our Pro brief analyzes why bilateral deal-making has undermined the trade group model, what it means for the next PhRMA CEO, and how mid-sized biotechs without individual White House relationships are positioned in a post-PhRMA policy environment. [Details below.]
What to Watch
The board’s search timeline and candidate profile will signal whether PhRMA is seeking continuity or transformation. A successor from traditional government affairs would suggest PhRMA believes the bilateral era is temporary. A successor from outside the lobbying world—a former executive, a policy entrepreneur, a communications leader—would signal that the organization is preparing for a fundamentally different role.
FDA Proposes Expedited IND Pathway to Accelerate Phase 1 Trials
What Happened: The FDA released its FY2027 budget request on April 3, totaling $7.2 billion ($3.3 billion from congressional appropriations, $3.9 billion from user fees), a 3.2% increase over FY2026. Within the budget, Commissioner Makary proposed the most structurally ambitious regulatory reform in years: a new Expedited IND pathway.
How the Expedited IND Would Work
The Expedited IND would be an optional, risk-based alternative to the traditional Investigational New Drug process for certain Phase 1 clinical trials. Under the current framework, sponsors must complete extensive animal pharmacology and toxicology studies before dosing the first human patient. This preclinical requirement is one of the most expensive and time-consuming steps in early drug development, and for small biotechs with limited capital, it can be the barrier that prevents promising candidates from ever reaching the clinic.
The proposed pathway would allow sponsors to use validated new approach methodologies (NAMs)—computational models, organoids, organ-on-chip systems, and microphysiological platforms—to satisfy preclinical safety requirements where the non-animal data is sufficient to support a safety determination. The FDA explicitly framed this as a competitive response to China’s regulatory framework, which has attracted early-stage drug development activity away from the United States through faster approval of first-in-human studies.
Who Benefits Most
The Expedited IND would disproportionately benefit small biotechs that currently face prohibitive costs in the traditional IND process. For companies with limited runway, eliminating or substantially reducing the animal testing requirement could mean the difference between reaching Phase 1 and running out of cash before ever dosing a patient.
The pathway would also benefit companies developing validated non-animal preclinical methodologies, as the Expedited IND creates a direct regulatory application for those technologies. The broader significance is that the FDA is explicitly acknowledging that its own preclinical requirements have contributed to early-stage development activity migrating to faster regulatory jurisdictions.
The Risks and the Open Questions
The tension in the proposal is between speed and safety. Lowering the barrier to Phase 1 increases the number of candidates entering clinical testing, but if the quality of preclinical safety assessment declines, the consequences manifest as adverse events in human subjects. The FDA acknowledged this explicitly, noting that dose-escalation controls, pharmacokinetic assessments, and preclinical safety margins must not be compromised.
The practical implementation depends heavily on which NAMs the FDA considers validated for which therapeutic areas. Computational toxicology models are more mature in oncology and certain inflammatory indications than in neuroscience or cardiovascular disease. The Expedited IND will likely be available for a subset of drug candidates initially, with gradual expansion as NAM validation data accumulates.
Fierce Pharma noted this is Commissioner Makary laying out “an ambitious legislative wish list” one year into his tenure. Whether Congress acts on the Expedited IND proposal—especially with multiple FDA user fee agreements (drugs, biologics, devices, biosimilars, generics) expiring September 30, 2027 and negotiations underway—is the open question.
Other Notable Budget Proposals
The FY2027 request included several additional proposals worth tracking:
DTC Advertising Authority: New statutory power to deem drugs misbranded if direct-to-consumer ads lack fair balance or create misleading impressions. The authority would extend to compounded drugs—a notable expansion given the ongoing GLP-1 compounding crackdown.
Domestic Manufacturing Incentives: $9 million for an FDA “PreCheck” program to accelerate domestic facility establishment. A separate proposal would give U.S.-based generic manufacturers a one-month head start on Paragraph IV patent challenge certifications, structurally favoring domestic production for 180-day marketing exclusivity. The National Law Review called this “a clever, targeted incentive that could meaningfully shift the calculus for companies deciding where to build capacity.”
Biosimilar Streamlining: Proposals to resolve the statutory distinction between biosimilar and interchangeable biosimilar products—a regulatory technicality that has created confusion in the market and may have suppressed biosimilar adoption.
Our Pro brief includes a deep dive on how the Expedited IND pathway would work in practice, who benefits most, the China competition framing, and how the proposal may be bundled into user fee reauthorization legislation. [Details below.]
The Week in Review: The Most Consequential Week in Biopharma This Year
This week delivered an extraordinary density of catalysts that, taken together, reshaped multiple dimensions of the biopharma landscape simultaneously:
April 1: FDA approved Foundayo (orforglipron), Lilly’s oral GLP-1 for obesity, under the CNPV program. Fastest NME approval since 2002. Shipping started April 6 through LillyDirect at $149 per month.
April 2: Trump signed Section 232 tariffs imposing 100% duties on imported patented pharmaceuticals. Tiered exemptions for onshoring (20%), MFN pricing (0%), allied countries (15%). Generics and biosimilars exempt.
April 3: FDA released FY2027 budget with Expedited IND pathway proposal and DTC advertising enforcement authority.
April 6: Neurocrine acquired Soleno for $2.9 billion (Vykat XR, Prader-Willi syndrome). Anthropic acquired Coefficient Bio for $400 million (biotech AI). Takeda terminated its Denali partnership. Citeline reported the global pipeline contracted for the first time since the 1990s.
April 7: Gilead acquired Tubulis for up to $5 billion (ADC oncology), its third acquisition in six weeks totaling approximately $15 billion. Sanofi reported mixed lunsekimig Phase 2 results (hit in asthma, missed in eczema). AbbVie listed Humira on TrumpRx at 86% off.
April 8: PhRMA CEO Steve Ubl announced departure at end of 2026. FDA Expedited IND pathway details released.
No single week in 2026 has combined regulatory approvals, trade policy, M&A activity, clinical data, AI investment, pipeline statistics, and institutional leadership transitions at this density. The convergence of these events creates a fundamentally different operating environment for the second quarter than the one that existed when Q1 ended.
Strategic Themes
1. The Collective Lobbying Model Is Under Structural Pressure
PhRMA’s declining influence is not about Steve Ubl’s performance—it is about a structural shift in how drug pricing policy is being made. When the government engages with the industry collectively, trade groups have leverage. When the government negotiates one company at a time, trade groups become overhead. The Section 232 tariff framework, MFN pricing agreements, and TrumpRx listings all reward individual company cooperation. This dynamic will persist regardless of who leads PhRMA, and it creates a policy environment where mid-sized biotechs without individual White House relationships are the most disadvantaged players.
2. The FDA Is Actively Competing with China for Early-Stage Drug Development
The Expedited IND proposal is explicitly framed as a competitive response to regulatory environments that have attracted clinical development activity away from the United States. This is the FDA acknowledging that its own processes are a barrier to innovation and proposing structural reforms to address the problem. If implemented, the pathway would lower the cost of entering Phase 1 trials, disproportionately benefiting small companies that cannot afford traditional animal toxicology programs.
3. This Week Changed the Operating Environment for Q2
The convergence of Foundayo’s approval, Section 232 tariffs, the PhRMA leadership transition, and the Expedited IND proposal creates a fundamentally different policy and competitive landscape than what existed at the start of the month. Oral GLP-1 competition is now live. Tariff compliance is now a corporate strategy requirement. PhRMA’s advocacy model is in transition. And the FDA is proposing to rewrite how drugs enter the clinic. Companies that treated these as isolated developments will miss the systemic implications of their simultaneous arrival.
4. The Numbers From This Week Tell the Full Story
$5 billion in Gilead/Tubulis. $2.9 billion in Neurocrine/Soleno. $400 million in Anthropic/Coefficient Bio. 100% tariff rate on patented pharmaceuticals. 86% Humira discount on TrumpRx. 50-day Foundayo approval. $149 per month self-pay price. 22,940 drugs in global development, down 3.9%. $38 million in PhRMA’s record lobbying spend. $7.2 billion FDA budget request. Every number represents a structural shift that will influence decision-making across the industry for the rest of the year.
Frequently Asked Questions
Why is Steve Ubl leaving PhRMA?
Ubl is stepping down after more than a decade as the administration’s bilateral deal-making strategy has sidelined PhRMA’s collective lobbying model. Sixteen of seventeen major drugmakers signed MFN pricing agreements directly with the White House without PhRMA’s involvement. The trade group’s record $38 million lobbying spend in 2025 produced less policy influence than individual CEO negotiations with the administration. Ubl will remain through the end of 2026 or until a successor is appointed.
What is the FDA’s proposed Expedited IND pathway?
An optional, risk-based alternative to the traditional IND process that would allow certain Phase 1 trials to begin using validated non-animal testing methods (NAMs) instead of traditional animal pharmacology and toxicology studies. The proposal is explicitly framed as a competitive response to China’s faster regulatory timelines and would disproportionately benefit small biotechs that face prohibitive costs in the current IND framework.
Who would benefit most from the Expedited IND?
Small biotechs with limited capital that currently face prohibitive costs in traditional animal toxicology programs before entering Phase 1. Companies developing validated non-animal preclinical methodologies would also benefit as the Expedited IND creates a direct regulatory application for their technologies.
What other proposals are in the FDA’s FY2027 budget?
New DTC advertising enforcement authority that could deem drugs misbranded for misleading ads (including compounded drugs), $9 million for a domestic manufacturing PreCheck program, a one-month Paragraph IV filing head start for U.S.-based generic manufacturers, and proposals to resolve the biosimilar versus interchangeable biosimilar distinction.
What happened this week in biopharma?
Foundayo approved and shipping at $149 per month. Section 232 tariffs signed at 100% on patented pharma imports. Gilead acquired Tubulis for $5 billion (third deal in six weeks). Neurocrine acquired Soleno for $2.9 billion. Sanofi’s lunsekimig hit in asthma but missed in eczema. AbbVie listed Humira on TrumpRx at 86% off. Anthropic bought Coefficient Bio for $400 million. The global pipeline contracted for the first time in 30 years. And PhRMA’s CEO announced his departure.
Will the Expedited IND actually be implemented?
It depends on Congress. The proposal is part of Commissioner Makary’s legislative wish list and may be bundled into FDA user fee reauthorization legislation, which must be passed before multiple user fee agreements expire on September 30, 2027. Negotiations are underway now. Stakeholder input and draft guidance would precede any implementation.
How does PhRMA’s situation affect mid-sized biotechs?
Mid-sized biotechs are the most disadvantaged by the shift to bilateral deal-making. Large pharma companies can negotiate MFN pricing agreements and tariff exemptions directly with the White House. Small biotechs lack that leverage. PhRMA’s collective advocacy was theoretically supposed to represent their interests, but the trade group’s influence has diminished. The Section 232 tariff deadline of September 29 for non-large companies creates real urgency for mid-sized biotechs to negotiate their own agreements.
What is the FDA’s China competition framing?
The FDA explicitly cited China’s faster regulatory timelines as a reason for proposing the Expedited IND. Early-stage drug development activity has migrated to jurisdictions that offer quicker paths to first-in-human dosing, and the FDA is acknowledging that its own preclinical requirements have contributed to that migration. The Expedited IND is designed to make the U.S. more competitive for Phase 1 trials by reducing the cost and time required to enter the clinic.
BioMed Nexus Pro — What Institutional Subscribers Are Reading Today
PhRMA’s Relevance Problem. We analyze why bilateral deal-making has structurally undermined the trade group model, what the next CEO inherits, and how mid-sized biotechs without individual White House relationships are positioned in a post-PhRMA policy environment. The $38 million lobbying spend produced less influence than a phone call between a CEO and the Commerce Secretary. What does that mean for the future of collective industry advocacy?
Expedited IND Deep Dive. We break down how the proposed pathway would work in practice, map which therapeutic areas and preclinical methodologies are closest to validation, assess the competitive implications for small biotechs versus large pharma, and analyze how the proposal may be bundled into user fee reauthorization negotiations.
The Week That Changed Everything. Foundayo. Section 232. $8B in M&A. A contracting pipeline. A PhRMA leadership vacuum. We map the convergence of this week’s events into a framework for how the operating environment has shifted for Q2 2026 and what it means for portfolio positioning across metabolic, oncology, immunology, and medtech.
Plus: Foundayo Week 1 commercial monitoring, Section 232 tariff compliance tracking, user fee reauthorization timeline, and the updated catalyst calendar through H2 2026.
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