Healthy Returns: FDA launches program to streamline creation of new U.S. drug manufacturing sites 

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A new program from the Trump administration aims to make setting up manufacturing plants in the U.S. less of a headache for the pharmaceutical industry. 

The Food and Drug Administration on Thursday announced a new “PreCheck” program, which will use a two-phase approach to help boost domestic drug manufacturing after it shrunk dramatically over the past two decades.  

The announcement is a direct response to President Donald Trump’s executive order in May calling on the FDA to reduce regulatory hurdles for domestic drug production in the U.S.. That order asked the agency to cut the amount of time it takes to approve new plants by eliminating unnecessary requirements, while also increasing the fees for and inspections of manufacturing facilities abroad. 

It follows a flurry of plans for new U.S. manufacturing investments from several drugmakers, such as Johnson & Johnson, AbbVie and Eli Lilly, in a bid to build goodwill with Trump. Still, the president could impose tariffs on pharmaceuticals imported into the U.S. any day now — a move that the industry argues could harm innovation and patient access to certain treatments.

So, why has Trump made reshoring drug production a key facet of his trade policy? 

More than half of pharmaceuticals distributed in the U.S. are manufactured overseas, according to a release from the FDA. Only 11% of companies that produce active pharmaceutical ingredients are based in the U.S., while a significant share are in China and India, the agency added. 

The White House also estimates that it can currently take five to 10 years to build new manufacturing capacity for pharmaceuticals, which it previously called “unacceptable from a national-security standpoint.”

“Our gradual overreliance on foreign drug manufacturing has created national security risks,” FDA Commissioner Dr. Marty Makary said in the release on Thursday. “The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America’s reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply.”

Here’s how the two phases of the program work:

• Facility Readiness Phase: Drugmakers will be able to engage more frequently with the FDA at “critical development stages” such as facility design, construction and pre-construction, the agency said. Companies will also use “Drug Master Files,” a facility-specific document that provides comprehensive information, including site layout and operations.
• Application Submission Phase: The agency said this step would involve the FDA and drugmakers holding pre-application meetings and giving early feedback to resolve issues and streamline assessments of “quality information in a drug application and inspections.” (That is referring to the Chemistry, Manufacturing, and Controls, or CMC, section of an application, which provides a comprehensive overview on the drug substance, its manufacturing process and controls in place to ensure its quality and stability.) 

The FDA will host a public meeting on Sept. 30, where it will present on the program and discuss other proposals to “overcome current onshoring challenge,” among other issues.

Until then, concrete details on the program are sparse. It’s unclear what requirements the FDA could eliminate, and how much less time it could take to approve new sites. 

We’ll continue to watch as this program gets finalized and implemented, so stay tuned for our coverage! 

Feel free to send any tips, suggestions, story ideas and data to Annika at [email protected].

Like it or not, more and more patients are turning to OpenAI’s artificial intelligence chatbot ChatGPT to answer questions about their health care. And the company is paying attention. 

OpenAI launched its latest large-scale AI model called GPT-5 last week, and the startup said it’s the “best model yet” for health-related queries. The product is designed to proactively flag health concerns, ask relevant questions and generate more precise and reliable responses, the company said in a blog post. 

“Health care is maybe the area where there’s the strongest improvement of any (is this one extra?) of any category,” OpenAI CEO Sam Altman told CNBC’s “Squawk Box” in an interview about GPT-5 on Friday. 

Altman said health-related questions make up a “huge fraction” of ChatGPT usage. In a post on X, he said he hopes GPT-5’s health capabilities will “provide real service to people.”

OpenAI said GPT-5 scores “significantly higher” than previous models on its health-care AI benchmark called Health Bench. 

The company released Health Bench in May, and it’s designed to measure how well AI models perform in realistic health scenarios. HealthBench was developed alongside 262 doctors from 60 countries. OpenAI said it’s based on 5,000 conversations that simulate interactions between individual users or clinicians and AI models. 

OpenAI is also touting GPT-5 as a helpful tool for medical research. 

The company released a two-minute-long video with Dr. Derya Unutmaz, a professor and human immunologist, which demonstrates how he has been using the model. Unutmaz said GPT-5 is able to help him brainstorm, interpret data and save him time by predicting outcomes of potential experiments. 

“I think GPT-5 will help the patients to advocate for themselves, and I think that will empower the patients to feel more confident when they talk to their doctors,” Unutmaz said in the video. 

Read more of CNBC’s coverage about GPT-5 here.

Feel free to send any tips, suggestions, story ideas and data to Ashley at [email protected].