FDA launches program to spice up U.S. drug manufacturing 

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A brand new program from the Trump administration goals to make organising manufacturing plants within the U.S. less of a headache for the pharmaceutical industry. 

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

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

It follows a flurry of plans for brand spanking new U.S. manufacturing investments from several drugmakers, comparable to Johnson & Johnson, AbbVie and Eli Lilly, in a bid to construct 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? 

Greater than half of pharmaceuticals distributed within the U.S. are manufactured overseas, in line with a release from the FDA. Only 11% of corporations that produce lively pharmaceutical ingredients are based within the U.S., while a major share are in China and India, the agency added. 

The White House also estimates that it could currently take five to 10 years to construct latest manufacturing capability 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 discharge on Thursday. “The FDA PreCheck initiative is one in all many steps FDA is taking that might help reverse America’s reliance on foreign drug manufacturing and make sure that Americans have a resilient, strong, and domestic drug supply.”

Here’s how the 2 phases of this system work:

• Facility Readiness Phase: Drugmakers will have the opportunity to interact more continuously with the FDA at “critical development stages” comparable to facility design, construction and pre-construction, the agency said. Firms may even use “Drug Master Files,” a facility-specific document that gives 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’s 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 make sure its quality and stability.) 

The FDA will host a public meeting on Sept. 30, where it can present on this system and discuss other proposals to “overcome current onshoring challenge,” amongst other issues.

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

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

Be at liberty to send any suggestions, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.

OpenAI launched its latest large-scale AI model called GPT-5 last week, and the startup said it is 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 corporate said in a blog post. 

“Health care is perhaps the world where there’s the strongest improvement of any (is that 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 corporate 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 can be touting GPT-5 as a helpful tool for medical research. 

The corporate 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 in a position to help him brainstorm, interpret data and save him time by predicting outcomes of potential experiments. 

“I believe GPT-5 will help the patients to advocate for themselves, and I believe that may empower the patients to feel more confident after they check with their doctors,” Unutmaz said within the video. 

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

Be at liberty to send any suggestions, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.