The FDA starts program to increase the US drug production

FileToto: The headquarters of the US Food and Drug Administration (FDA) can be seen in Silver Spring, Maryland, November 4, 2009.

Jason Reed | Reuters

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A new Trump administration program aims to create the establishment of production facilities in the USA less headache for the pharmaceutical industry.

The Food and Drug Administration announced a new “Precheck” program on Thursday, which will use a two -phase approach to increase the production of domestic medication after it has been shrunk dramatically in the past two decades.

The announcement is a direct response to President Donald Trump's executive regulation in May to reduce the FDA in order to reduce the regulatory hurdles for the production of domestic medicines in the USA. This order asked the agency to shorten the time that is needed to approve new systems by deleting unnecessary requirements, and at the same time increasing the fees for and the inspections of manufacturing facilities abroad.

This is followed by a flood of plans for new US manufacturing investments by several drugmakers such as Johnson & Johnson, Abbvie and Eli Lilly, to build good will with Trump. Nevertheless, the president could force tariffs to pharmaceuticals every day that are imported in the United States – a step that the industry argues to impair innovation and the patient's access to certain treatments.

Why did Trump make the redesign of drug production a key facet of his trading policy?

According to the FDA, more than half of the drugs distributed in the USA are produced abroad. Only 11% of companies that produce active pharmaceutical ingredients are located in the United States, while a significant proportion is in China and India, the agency added.

The White House also estimates that it can currently take five to ten years to build a new production capacity for pharmaceuticals, which is previously referred to as “unacceptable from a point of view of national security”.

“Our gradual over -control for foreign drug production has introduced national security risks,” said the FDA commissioner Dr. Marty Makary on Thursday in the press release. “The FDA Precheck initiative is one of many steps that the FDA is doing that can help to reverse America's trust in foreign drug production and ensure that the Americans have a resilient, strong and domestic drug supply.”

This is how the two phases of the program work:

• Facility readiness phase: The drug manufacturers can often deal with the FDA in “critical development phases” such as design, construction and pre -building, said the agency. Companies will also use “drug master files”, a fazity -specific document that provides comprehensive information, including location layout and operations.
• Application examination phase: The agency said that this step would affect the FDA and drug manufacturers, hold the progress meetings and give early feedback to solve problems and to rationalize evaluations of “quality information in a drug registration and in the inspections”. (This refers to chemistry, production and control persons or CMC section of an application that offers a comprehensive overview of the drug substance, its manufacturing process and its controls to ensure their quality and stability.)

The FDA will organize a public meeting on September 30, in which it will be in the program, among other things, and will discuss other suggestions for the “overcome” current onshoring challenge “.

Until then, concrete details about the program are sparse. It is unclear what requirements the FDA could eliminate and how much less time could take for the approval of new websites.

We will continue to see how this program is completed and implemented. So stay on our reporting!

Feel free to send Annikakim.constantino@nbcuni.com tips, suggestions, ideas and data to Annika.

The latest in the healthcare system Tech: Openaai is based on the start of GPT-5 in health care

Sam Altman, CEO of Open Ai, speaks on June 2, 2025 on the annual Snowflake Summit in San Francisco, California.

Justin Sullivan | Getty Images News | Getty pictures

Whether you like it or not, more and more patients are turning to Openas Artificial Intelligence Chatbot -Chatgt to answer questions about your health care. And the company pays attention.

Openaai launched its latest AI model with the name GPT-5 last week, and the startup said it was the “best model” for health-related queries. The product was developed to mark health concerns, ask relevant questions and generate precise and more reliable answers, the company said in a blog post.

“Health care is perhaps the area in which it is most improved (is that extra?) In a category,” the Openai CEO Sam Altman told CNBCS “Squawk Box” in an interview on Friday.

Altman said that health-related questions make up a “large part” of the Chatgpt use. In a contribution to X, he hopes that GPT-5 health skills “offer people real service”.

Openaai said that GPT-5 values “significantly higher” than earlier models in his health AI benchmark called Health Bench.

The company published Health Bench in May and is intended to measure how well AI models do in realistic health scenarios. Healthbench was developed together with 262 doctors from 60 countries. Openaai said it is based on 5,000 conversations that simulate the interactions between individual users or clinics and AI models.

Openai also throws GPT-5 as a helpful instrument for medical research.

The company published a two -minute video with Dr. Derya Unutmaz, a professor and human immunologist, shows how he used the model. Unutmaz said GPT-5 could help him brainstorming brainstorming, interpreting data and saving him time by predicting the results of potential experiments.

“I think GPT-5 will help the patient to stand up for themselves, and I think that will enable the patient to feel safer when they talk to their doctors,” said Unutmaz in the video.

Read more about CNBC's reporting on GPT-5.

Feel free to send tips, suggestions, story ideas and data to Ashley at Ashley.capoot@nbcuni.com.