FDA leaders, in a visibly social mood, hosted a public hearing on Thursday to obtain feedback and perspectives on the controversial Commissioner’s National Priority Voucher pilot program.

To recap: the agency has publicly awarded 21 drug candidates with vouchers intended to accelerate review timelines to 1-2 months. Roughly one year since soliciting applications – and a near-complete turnover of agency leadership – seven products have received speedy review decisions through the pilot (six approvals, one rejection).

Speakers at the town hall-style event represented the pharma industry, academia, advocacy and beyond, with each participant required to provide the agency with talking points for approval. All appeared unified in the need for FDA leaders to establish and share clear eligibility criteria for pilot program participation.

Representatives of the biopharma industry – including PhRMA, Merck and Johnson & Johnson, were largely supportive of the program and its collaborative nature. However, industry-aligned speakers voiced concerns about political interference and tying pricing considerations to program participation.

Outside of industry, advocates lauded the principle of the CNPV program but shared reservations about its ambiguity, origin and a lack of transparency in drug selection. A handful of advocates for those with rare diseases or cancer referenced recent FDA rejections when urging the agency to consider their perspectives as part of program criteria. There was also debate over the program’s necessity, with some asserting the FDA already has existing expedited pathways that serve a similar purpose.

– Andrew Wishon, Editor-in-Chief

Proposed healthcare reforms in Germany are raising alarm bells for global drugmakers as policy uncertainty is beginning to outweigh the market’s historic appeal. For an industry that has long viewed Germany as a pricing anchor for Europe, the shift is forcing difficult, real-time decisions on where – and whether – to invest.

At the center of the debate is Berlin’s push to curb rising healthcare costs through lower drug prices, part of a broader effort to deliver roughly €12 billion in savings. But for pharmaceutical companies, these measures are introducing unpredictability into a market that has traditionally offered scale, strong pricing and global influence.

This isn’t the first time we’ve observed this dynamic. We saw similar business decisions in the UK last year amid warnings that the market had become “un-investable” due to pricing pressures. The British pharma industry ultimately secured policy concessions after signaling a pullback in investment.

The response in Germany has been swift and tangible. Eli Lilly signaled it will scale back plans for a major German manufacturing facility, cutting its planned €2.3 billion investment by half. Even domestic players are recalibrating: Boehringer plans to reduce its spending in-country by €900 million over the next three years, and BioNTech reaffirmed the need to work with policymakers on a “sustainable” investment climate.

These are not marginal decisions; they reflect a fundamental reassessment of Germany’s long-term viability as a hub for innovation and production.

The broader implication is that Germany risks eroding its position in the global biopharma ecosystem. In a capital-intensive industry, uncertainty is often more damaging than cost alone, and companies are increasingly willing to redeploy investment accordingly.

– Megan Hickey, Managing Director

Late last Friday, the White House issued an Executive Order on vaccines that may be more impactful in perception than policy.

The EO directs the CDC and the Advisory Committee on Immunization Practices to review a January 2026 scientific assessment authored by a controversial former FDA official, using the document to align the committee’s childhood and adolescent vaccine recommendations with those of other peer countries.

The accompanying White House fact sheet notes that the U.S. currently recommends “more than twice as many vaccine doses as some European nations,” and that most other peer nations maintain high vaccination rates without robust mandates. However, most experts agree that the assessment does not account for America’s unique circumstances, including a lack of universal health coverage and a population totaling more than 300 million.

What does the EO actually change? For now, not a whole lot.

Following Judge Brian Murphy’s ruling in American Academy of Pediatrics v. Kennedy, ACIP is currently non-functional and cannot amend its recommendations. Richard Hughes, the lead attorney in the ongoing lawsuit, called the EO “toothless.”

Yet, while insurers have committed to continue coverage of all recommended vaccines through 2027, the EO will likely create confusion and possibly increase hesitancy for American parents when it comes to routine vaccination.

Some speculate this may be an attempt by the Trump administration to restart ACIP activities ahead of a scheduled meeting later this June. Others think it may be political posturing to demonstrate loyalty to MAHA-aligned voters in advance of the November midterm elections.

– Rachel Bridges, Senior Director

One FDA update that may have flown under the radar could have important implications for how manufacturers engage payors in advance of regulatory approval.

This week, the agency updated draft guidance on ways manufacturers can communicate with payors about products in development, aligning agency policy with statutory protections enacted by Congress in 2023. The guidance explicitly states that manufacturers may share study results, economic analyses, pricing information, utilization projections and anticipated approval timelines—provided the information is truthful and non-misleading.

Manufacturers have long engaged payors before approval, but uncertainty around the fine line between information sharing and promotion often led to a cautious approach. By providing clearer guardrails, the FDA may give companies greater confidence to engage payors earlier on product value, access and reimbursement considerations.

– Leah Nebbia, Managing Director

• June 9 – committee hearing to markup HHS’ FY 2027 funding bill, House Appropriations
• June 9-10 – annual meeting for the payer advocacy group, AHIP
• June 10 – subcommittee hearing on “policies to increase healthcare transparency,” House Energy & Commerce

• “Trump changes course when confronted by powerful constituencies. Pharmaceutical executives are one of those constituencies.” – Steve Usdin, BioCentury
• “With distressing frequency, the FDA rejects safe drugs it says haven’t demonstrated enough efficacy…Here’s a solution: Remove efficacy from the FDA’s approval process and focus on safety alone.” – Charles L. Hooper & David R. Henderson, The Wall Street Journal
• “Patent protections incentivize innovation, which in turn sparks competition. But if drug companies couldn’t protect their ideas and designs from being copied for a period of time, they’d have no incentive to invest in research to attempt to enter the market in the first place.” – Melanie Whittington & Joshua Kresh, Washington Examiner

• ASCO’s sprawling exhibit hall underscored the growing importance of oncology branding and competition, with drugmakers using elaborate themed experiences and booth designs to stand out among nearly 500 exhibitors. Fierce Pharma: Coffee, racetracks, beaches and more coffee—inside the ASCO 2026 exhibit floor.
• The Supreme Court unanimously sided with a generic drugmaker in a closely watched patent-labeling dispute, a decision that could bolster generic competition. Axios: Supreme Court backs generic drugmaker in patent case.
• About 50 hospitals could lose 340B discounts on medicines from Eli Lilly if they fail to submit claims data to the drugmaker, escalating an industry push for greater program transparency. STAT: Eli Lilly warns hospitals to submit claims data in the next five days or lose their 340B drug discounts.
• Roche Chairman Severin Schwan criticized the Trump administration’s drug pricing tactics as “blackmail,” warning that the pressures of MFN pricing and tariffs could further shift pharma investment away from Europe. Bloomberg: Roche Chairman Accuses US Government of Drug Price ‘Blackmail.’
• Australian experts warned that President Trump’s drug pricing policies could make drugmakers less willing to launch medicines in the country. Herald Sun: Global tensions with US President Donald Trump could threaten affordable medicines in Australia.
• CMS is promoting Medicare’s new temporary coverage of obesity drugs but still has not disclosed the likely cost to taxpayers. STAT: Medicare still won’t say how much covering obesity drugs will cost.
• The White House is reviewing the FDA’s next user-fee deal with the biopharma industry, which includes “America First” provisions such as halving fees for companies running Phase 1 trials in the U.S. Endpoints: FDA’s next fee deal, stacked with US incentives, is under White House review.
• The FDA issued draft guidance suggesting cell and gene therapy developers can speed drug development by leaning more on existing scientific knowledge to avoid unnecessary testing. Axios: FDA issues industry-friendly gene therapy guidance.
• The U.S. House passed an appropriations bill with $7.1 billion in funding for the FDA, though further work is needed to align with Senators on a final spending package. The Hill: House passes agriculture and FDA appropriations bill.