The news: The FDA laid out a new FDA PreCheck initiative, aimed at helping pharma companies build US manufacturing plants more quickly.

Digging into the details: The new plan promises to streamline the review process and get rid of some regulations, along with earlier and more frequent agency contact.

• FDA chief Marty Makary said the plan is a direct response to President Trump’s executive order in May to spur US drug manufacturing.
• The agency scheduled a public meeting for September 30 to hear suggestions and discuss details about applying.

Why it matters: Trump is pushing drugmakers to manufacture more drugs in the US via executive orders and tariff threats. But it typically takes 5-10 years and costs up to $2 billion to build a new plant, per the PhRMA trade group.

In response to tariff pressures, 15 pharma companies have committed $270 billion to reshoring US manufacturing and R&D over the next 5-10 years, per JLL’s US Life Sciences Property Report. That includes pledges from Johnson & Johnson ($55 billion), AstraZeneca and Roche ($50 billion each), and Eli Lilly ($27 billion).

The takeaway: FDA PreCheck may ease manufacturing regulations and trim review time, but navigating real estate, construction, and skilled labor issues still means pharma companies are facing years-long timelines to reshore drug manufacturing.

Trump has promised a year or two grace period on his proposed 250% tariffs, but that may not be long enough to get plants up and running. Pharma should look to cut deals—like Apple’s recent tariff exemption granted by Trump after it promised to invest $100 billion in US manufacturing—to guarantee exemptions as long as projects are underway.

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.