The FDA launch program to boost the manufacture of American medicines

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A new Trump administration program aims to make the creation of manufacturing plants in the United States less headache for the pharmaceutical industry.

The food and medication administration announced on Thursday a new “Precheck” program, which will use a two -phase approach to help boost the manufacture of domestic drugs after it was drastically reduced in the last two decades.

The announcement is a direct response to the executive order of President Donald Trump in May that asks the FDA to reduce regulatory obstacles for the production of national drugs in the United States. That order asked the agency to reduce the amount of time to approve new plants eliminating unnecessary requirements, while increasing rates and inspections of manufacturing facilities abroad.

It follows a lot of plans for the new manufacturing investments of the United States of several drug manufacturers, such as Johnson & Johnson, Abbvie and Eli Lilly, in an attempt to build goodwill with Trump. Even so, the president could impose tariffs on the pharmaceutical products imported to the US. At any time, a measure that the industry argues could damage innovation and access to the patient to certain treatments.

So why has Trump make the writing of drug production a key facet of his commercial policy?

According to an FDA statement, more than half of the pharmaceutical products distributed in the United States are manufactured abroad, according to an FDA statement. Only 11% of companies that produce active pharmaceutical ingredients are based on the US, while significant participation is in China and India, added the agency.

The White House also estimates that it can take five to 10 years to build a new manufacturing capacity for pharmaceutical products, which it previously called “unacceptable from a national security point of view.”

“Our excessive gradual dependence in the manufacture of foreign medicines has created national security risks,” the FDA Commissioner, Dr. Marty Makary, in the statement, said Thursday. “The FDA Precheck initiative is one of the many steps that the FDA is taking that can help reverse the dependence of the United States in the manufacture of foreign medicines and ensure that Americans have a supply of resistant, strong and domestic medicines.”

This is how the two phases of the program work:

• Installation preparation phase: Medication manufacturers can participate more frequently with the FDA in “critical development stages”, such as the design of facilities, construction and pre-construction, said the agency. Companies will also use “Medication Master Archives”, a specific document of the installation that provides comprehensive information, including site design and operations.
• Application shipping phase: The agency said that this step would involve the FDA and medication manufacturers that celebrate meetings prior to the application and grant early comments to solve problems and rationalize the evaluations of “quality information in an application and drug inspections.” (This refers to chemistry, manufacturing and controls, or CMC, the section of an application, which provides a complete description of the drug substance, its manufacturing process and controls to guarantee its quality and stability).

The FDA will organize a public meeting on September 30, where it will be presented in the program and will discuss other proposals to “overcome the current wave challenge”, among other topics.

Until then, the concrete details about the program are scarce. It is not clear what requirements could eliminate the FDA and how much less time could take to approve new sites.

We will continue to observe as this program is finished and implemented, so be attentive for our coverage!

Do not hesitate to send any advice, suggestion, stories ideas and data to Annika in [email protected].

We like it or not, more and more patients are resorting to OpenAi's artificial intelligence chatbot to answer questions about your medical care. And the company is paying attention.

Operai launched his latest large-scale AI model called GPT-5 last week, and the startup said it is the “best model” for health-related consultations. The product is designed to mark health concerns proactively, ask relevant questions and generate more precise and reliable answers, the company said in a blog post.

“Medical care is perhaps the area where there is the strongest improvement of any (is this extra?) Of any category,” said Openai CEO, Sam Altman, “Squawk Box” by CNBC in an interview about GPT-5 on Friday.

Altman said that health -related questions constitute a “great fraction” of the use of chatgpt. In a publication about X, he said that GPT-5 health capacities “provide real service to people.”

Operai said that GPT-5 obtains “significantly higher” than the previous models in its reference point of medical care called Health Bench.

The company launched Health Bench in May, and is designed to measure how well the AI models work in realistic health scenarios. Healthbench developed along with 262 doctors from 60 countries. Openai said that it is based on 5,000 conversations that simulate interactions between individual or medical users and AI models.

Operai is also promoting GPT-5 as a useful tool for medical research.

The company launched a two -minute video with Dr. Dirya Unutmaz, teacher and human immunologist, who demonstrates how she has been using the model. Unutmaz said that GPT-5 can help you make a rain of ideas, interpret it and save time when predicting the results of potential experiments.

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

Read more about CNBC coverage on GPT-5 here.

Do not hesitate to send any advice, suggestion, stories ideas and data to Ashley at [email protected].