Nine chairs of Europe’s largest pharmaceutical companies—AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Ipsen, Novartis, Novo Nordisk, Roche and Sanofi—published an open letter to national leaders warning that without decisive action, the industry’s “future will be built elsewhere.”

The letter argues that Europe is squandering one of its “great post-war achievements.” In fact, it points to EFPIA data showing that Europe’s share of global pharma R&D has fallen from 43% in 1990 to 31% today, with over 40% of newly approved therapies not available to European patients in 2025.

The letter also highlights that Europe’s global share of commercial clinical trials has halved to 9% over the past decade, as EU Commissioner Várhelyi noted in his opening remarks to European Parliament’s SANTE-ITRE committee exchange on the Biotech Act in March of this year.

Furthermore, Reuters reported that other countries have moved more quickly. The Guardian specifies this is why, for example, announcements for more than $600 billion in pharmaceutical investments have been made in the U.S. and China over the last two years alone.

Yet, patient and consumer groups view the competitiveness alarm sceptically. They argue that because data from the letter originates with the industry or its representative trade association in Europe, it effectively “doubles as a lever to raise European prices and to soften planned reforms that would speed cheaper generics and biosimilars to patients.”

Nonetheless, the company chairs are asking national leaders to work with them “to reverse Europe’s declining competitiveness” and “unleash a new era of medical discovery.” They argue that accelerating clinical trials, strengthening IP protections and giving member states fiscal flexibility to invest in innovative medicines is just as strategically important as financing energy or defence infrastructure.

Whether national governments will heed the chairs’ call or national fiscal pressures will prevail instead, remains to be seen.

– Francesca Boldrini, Managing Director

With the second wave of Section 232 pharmaceutical tariffs taking effect on Monday (September 29), the U.S. Commerce Department issued vague exemption guidance acknowledging that the unsettled process “creates uncertainty for companies’ understanding of their tariff liability.”

In April, President Trump imposed 100% Section 232 tariffs on imported patented pharmaceuticals and active ingredients, citing national security concerns from foreign manufacturing dependence. The framework set two dates — July 31 for large multinationals and September 29 for all other companies — and offered “off-ramps”: a 20% rate with an onshoring plan, or 0% by pairing onshoring with an MFN pricing deal. That window closed June 12 after thirteen large multinationals secured deals. Generics and biosimilars remain exempt, for now.

Smaller and mid-sized companies dependent on external manufacturing bear most of the remaining uncertainty. The guidance defines which specialty products qualify for a 0% rate but not how or when exemption decisions will be made. The picture least clear for rare disease: orphan drugs carry a nominal exclusion, but the criteria are narrow. All approved indications must hold orphan designation, and products must originate from a qualifying trade partner or meet an “urgent U.S. health need” standard that Commerce has not yet defined.

The domestic pressure runs parallel to a broader international pricing push. A U.S. trade hearing on Germany’s drug pricing practices drew support from PhRMA and BIO for a binding bilateral agreement requiring Berlin to increase spending on innovative medicines. The Section 301 probe follows the template of the U.S.-UK deal and could extend to France and Japan, part of the administration’s strategy to use tariff pressure to drive manufacturing and pricing concessions at home while pushing trading partners to pay more for U.S.-developed medicines.

Taken together, the tariff approach is garnering responses from those with leverage: the largest drugmakers have secured deals, and trading partners are being pressed toward their own. Smaller and mid-sized companies, meanwhile, are left to decide pricing, supply and launch timing around the full 100% rate or risk an unplanned tariff bill.

– Leslie Isenegger, Head of Policy, Public Affairs and Access, RC Resolve

During one of the last working days for Congress ahead of the November elections, the Senate HELP Committee hosted a confirmation hearing for Dr. Heidi Overton, the nominee for FDA commissioner.

Overton has served as a trusted White House advisor, standing behind President Trump as he signed an August 10 Executive Order on childhood vaccines and called the MMR vaccine “quite lethal.” HELP Committee Chair Bill Cassidy, R-La., was vocal ahead of the hearing that his vote of support for Overton hinged on her willingness to correct vaccine misinformation.

During Cassidy’s questioning, Overton contradicted President Trump and defended the MMR vaccine, calling it “our best tool right now in the public health response to the measles outbreak.” She went a step further, saying “every vaccine on the U.S. market right now is safe and effective, according to the FDA.”

However, Overton repeatedly declined to directly say whether she disagrees with the president. She also skirted questioning on hot-button issues like changes to the FDA recommendations for mifepristone, leaving doubts for many on her ability to fulfill FDA’s mission in the face of political pressure. Instead, Overton shifted focus toward her vision for accelerating clinical trials and combating China’s rising dominance in R&D – something industry has been clamoring for in a tumultuous year of FDA turnover.

Despite the White House’s desire to install a new FDA leader before November, the clock may run out before the Senate receives enough concrete answers to assuage any doubts about her nomination. Thus, an acting commissioner could still be at the helm through the rest of 2026.

– Rachel Bridges, Senior Director

Last week, the Chinese government unveiled a five-year plan for its pharmaceutical industry—and it reads less like an industry roadmap and more like a national competitiveness strategy.

By 2030, China aims to meet three goals for domestically developed medicines:

• account for at least 25% of the global total of first-in-class medicines
• have at least five medicines that generate more than $1 billion in annual global sales
• achieve 20% annual growth in its innovative drug sector

The plan also calls for greater R&D investment, AI-enabled drug development, international clinical trials and stronger support for Chinese companies commercializing products worldwide.

The government is positioning biopharma as a pillar industry alongside industries like semiconductors and aerospace that are seen as critical to long-term economic and geopolitical strength. Currently, Chinese companies account for roughly one-third of the global innovative drug pipeline, and outbound licensing activity continues to accelerate. The next step is turning that momentum into globally dominant products and companies.

What stands out is the level of coordination. China has a national strategy with measurable targets, government backing and alignment across regulators, industry and economic planners. By contrast, the U.S. remains largely dependent on market forces and fragmented policymaking.

For years, biotech leaders have argued that the U.S. lacks a cohesive life sciences strategy as China continues investing heavily in R&D and infrastructure. While Washington talks about maintaining biotech leadership, China is bringing clear benchmarks alongside a national plan to achieve them.

– Stephen Tellone, Associate Director

• Sept. 29 – U.S. tariffs take effect on patented pharmaceuticals and ingredients (with exceptions), Department of Commerce

• “The FDA needs a leader who can turn important health challenges into policy initiatives that the agency can develop and carry out, and who trusts and supports the people implementing them. Overton has hard work to do but has demonstrated the capacity to be that leader.” – Scott Gottlieb & Mark McClellan, STAT
• “Patients and policymakers have every right to be angry about the often unaffordable cost of medicines. But they shouldn’t fall for PBMs’ and insurers‘ blame game.” – Anne Pritchett, Washington Examiner
• “When policy systematically undervalues innovation, investment becomes harder to sustain, the pace of discovery can slow and patients may wait longer for – or worse, never see – the treatments they and their loved ones desperately need.” – Perry Siatis, RealClearHealth

• The Senate Finance Committee voted 15-12 to advance Christopher Klomp’s nomination to serve as HHS deputy secretary. Politico: Finance Committee advances Klomp for deputy health secretary.
• Despite White House claims, states are still evaluating whether the GENEROUS Medicaid drug-pricing model offers savings beyond existing rebates. STAT: Trump boast on drug pricing policy overstated state-level interest in federal program.
• An analysis of TrumpRx prices for 32 brand-name drugs was nearly evenly split between being cheaper and more expensive than average prices in comparable countries. KFF: How TrumpRx Brand-Name Drug Prices Compare to Other Countries.
• Newly released documents show the Trump administration’s drug-pricing agreements with Pfizer and Eli Lilly include tariff protections and incentives to raise drug prices overseas that were not previously disclosed. The Washington Post: Secret contracts reveal undisclosed terms in Trump’s drug-pricing deals.
• The European Union is nearing final adoption of a sweeping pharmaceutical reform package that would update drug development, approval and market protection rules for the first time in more than two decades. Pink Sheet: Almost There? EU Officials Hint Pharma Reform Nearing Adoption.
• Rising healthcare costs are fueling a new wave of populist campaign rhetoric, with candidates in competitive congressional races pledging to take on drug companies, insurers and others. Axios: Midterms’ new populism: Taking on health industries.
• A nonprofit affiliated with HHS Secretary Kennedy and the MAHA movement reportedly offered companies sponsorship packages that included access to senior federal health officials. Bloomberg: RFK Jr.-Linked Group Offered Access to US Officials for Fee.