See what's clicking on FoxBusiness.com.
The Food and Drug Administration is moving forward with a regulatory overhaul to limit US reliance on foreign drugs and cut red tape to allow American manufacturers to fill the void, FOX Business has learned.
The FDA is proposing a new rule on Friday that aims to streamline procedures for US drug manufacturers while imposing stricter regulations on foreign ones.
The FDA is launching a new website to accompany the overhaul detailing all the ways the agency can help American manufacturers. A major gap the reforms seek to address is foreign factories that produce raw materials for drugs that remain completely invisible in the US by moving products to centralized locations overseas.
“The FDA is proposing changes to our registration process that will reflect how distributed manufacturing works – like a single facility,” said Dr. Michael Davis, acting director of the FDA's Center for Drug Evaluation and Research, in a statement.
“The proposed changes will make it easier for innovative manufacturers to operate efficiently, and give the FDA a clearer, more accurate picture of how and where drugs are made,” he added.
THE UNSTOPPABLE REASON IN AN AGE THAT NEW MEDICINE IS TAKING THE RIGHT WAY — AND THE $10 TRILLION FIX
The Food and Drug Administration is moving forward with reforms to limit US reliance on imported drugs and cut red tape. (Sarah Silbiger/Getty Images/Getty Images)
“When the active ingredient in a drug reaches the American patient, the FDA must be able to track where it came from,” said Davis. “Closing this gap in the registration of foreign institutions is a concrete step in increasing the transparency that patients deserve.”
Officials say current rules force American companies to register every manufacturing unit as a completely separate factory. The new regulations will allow this to be made into a single registration.
19 DRUG APPROVALS IN 2024 WITH 'MAJOR HEALTH IMPACT,' ACCORDING TO GOODRX
FDA Commissioner Dr. Marty Makary joins 'Mornings with Maria' to discuss the agency's push to speed up life-saving drugs, fight copycat weight loss drugs and deliver faster treatments without compromising safety.
The website will also provide tracking on the progress of other FDA anti-bullying programs, such as TrialBlazer, the PreCheck Pilot Program and others.
Eli Lilly CEO Dave Ricks Joins 'Varney & Co.' to discuss the Trump administration's new Medicare GLP-1 bridge program, which will give eligible seniors access to Lilly's weight-loss drugs for $50 a month starting July 1.
CLICK HERE FOR FOX BUSINESS ON THE GO
TrialBlazer wants to increase the development of new drugs in the US by relying more on accounting during the development and approval process and allowing more flexible rules for clinical trials.
The pilot program aims to help US companies establish manufacturing facilities in the US
