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Faster drug approvals are possible with global price concessions, FDA chief says

The news: Pharma companies can earn a speedier path to approvals for new drugs if they agree to lower US prices to global levels, FDA Commissioner Marty Makary told Bloomberg Television.

If a pharma company equalizes its prices between the US and other countries, the FDA would be willing to fast-track that company’s applications for new drugs, Makary said.

Zooming out: Makary’s latest idea fits squarely with President Trump’s executive order in May that demanded drugmakers bring US medicine prices in line with other countries. For context: Other countries pay lower prices mostly through single-payer health systems where governments negotiate directly with pharma companies.

Last month, the FDA launched a pilot program for drugmakers to earn priority vouchers and shrink drug approval timelines from the typical 10 months to 1 to 2 months. The agency wants pharma companies to align with its national health priorities to earn the vouchers by taking such steps as addressing unmet public health needs, boosting US drug manufacturing, and delivering innovative cures.

Yes, but: Pharma trade association PhRMA argues that US patients get better access to the latest treatments.

  • 85% of drugs approved since 2012 are available in the US versus only 40% on average in the EU. 
  • Cancer patients in the US access 94% of new therapies versus only 60% being available in Canada, per PhRMA.

Why it matters: Drugmakers have long called for higher prices in Europe, but their efforts are gaining more urgency under pressure from Trump executive orders and tariff threats. The CEOs of Sanofi, Novartis, and AstraZeneca in April urged the EU to allow higher prices or risk falling further behind US investments.

The takeaway: Pharma companies are on board with faster drug approvals and higher global prices, but they still make the bulk of their profits on US sales. By adopting good faith balanced stances—advocating for fairer pricing, but highlighting innovation—pharma can notch wins with the administration and consumers.

This content is part of EMARKETER’s subscription Briefings, where we pair daily updates with data and analysis from forecasts and research reports. Our Briefings prepare you to start your day informed, to provide critical insights in an important meeting, and to understand the context of what’s happening in your industry. Not a subscriber? Click here to get a demo of our full platform and coverage.

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