Latest news with #FDAPreCheck
CNBC
8 hours ago
- Business
- CNBC
Healthy Returns: FDA launches program to streamline creation of new U.S. drug manufacturing sites
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: 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 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. Feel free to send any tips, suggestions, story ideas and data to Ashley at
The Hill
6 days ago
- Business
- The Hill
FDA moves to boost domestic drug supply
The Food and Drug Administration is launching a new program to ramp up the United States' domestic pharmaceutical supply chain, the agency announced Thursday. The program, called FDA PreCheck, is aimed at streamlining the pharmaceutical plant regulatory process. The FDA says this will in turn make it easier to build drug manufacturing sites within the U.S. FDA PreCheck would speed up the process in two phases. The first phase would provide more frequent communication between the FDA and manufacturers on developmental stages including facility design, construction and pre-production. The second phase would allow for pre-application meetings and early feedback on how a drug product will be manufactured and controlled. 'Our gradual overreliance on foreign drug manufacturing has created national security risks,' said FDA Commissioner Marty Makary. 'The FDA PreCheck initiative is one of the 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.' President Trump has said he wants drug companies to increase their domestic production, in part, to strengthen national security. He has pledged to impose tariffs on drug companies to get them to comply and threatened early this week to impose tariffs of up to 250 percent on pharmaceutical imports. Some drug companies are pouring billions of dollars into creating new domestic manufacturing plants. The drug company Eli Lilly said in February it plans to spend about $27 billion to build four new manufacturing plants. AstraZeneca is investing $50 billion over the next five years to expand its U.S. manufacturing. Johnson & Johnson announced in March it will spend more than $55 billion on research and to build three new manufacturing plants as well as expand several existing ones. The FDA is hosting a public meeting about the new program on Sept 30 where the agency will present draft framework. Participants will discuss the strengths and weaknesses of the proposed framework and 'additional considerations' that could help the pharmaceutical industry overcome challenges with onshoring, according to an unpublished notice on the meeting. These challenges may include 'pharmaceutical ingredients (APIs) and finished drug and biological products' as well as options the FDA has to further facilitate domestic production.
UPI
6 days ago
- Business
- UPI
FDA launches program to encourage American drug manufacturing
Aug. 7 (UPI) -- The U.S. Food and Drug Administration announced Thursday it is launching the "FDA PreCheck" program in order to help construct drug manufacturing sites in the United States. "Our gradual over-reliance on foreign drug manufacturing has created national security risks," said FDA Commissioner Marty Makary in a press release. "The FDA PreCheck initiative is one of many steps [the] 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." According to the release, over half the pharmaceuticals distributed within the United States are manufactured overseas, and active pharmaceutical ingredients, or APIs, are mostly procured from foreign sources. The PreCheck program will encourage creation of new American drug manufacturing facilities by widening the ability for medicine makers to communicate with the FDA, and by shortening the Chemistry, Manufacturing, and Controls sections of applications for sales and marketing of new drugs.
&w=3840&q=100)
Business Standard
6 days ago
- Business
- Business Standard
US FDA announces new program to boost domestic drug manufacturing
The program, called FDA PreCheck, aims to streamline review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements, the FDA said Reuters The US Food and Drug Administration on Thursday announced a new program to strengthen the domestic pharmaceutical supply chain, by facilitating construction of manufacturing sites in the United States. The program, called FDA PreCheck, aims to streamline review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements, the FDA said. The program also introduces a two-phase approach to facilitate new US drug manufacturing facilities.
Reuters
6 days ago
- Business
- Reuters
US FDA announces new program to boost domestic drug manufacturing
Aug 7 (Reuters) - The U.S. Food and Drug Administration on Thursday announced a new program to strengthen the domestic pharmaceutical supply chain, by facilitating construction of manufacturing sites in the United States. The program, called FDA PreCheck, aims to streamline review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements, the FDA said. The program also introduces a two-phase approach to facilitate new U.S. drug manufacturing facilities.
