FDA announcing new regulations to limit US reliance on foreign drugs

July 10, 2026:

FDA announcing new regulations to limit US reliance on foreign drugs

Check out what’s clicking on FoxBusiness.com.

The Food and Drug Administration is moving forward with a regulatory overhaul to limit U.S. reliance on foreign drugs and cut red tape to allow American manufacturers to fill the space, FOX Business has learned.

The FDA is proposing a new rule Friday that aims to streamline processes for American drug manufacturers while toughening regulation for foreign ones.

The FDA is launching a new website to go along with the overhaul that details all the ways the agency can assist U.S. manufacturers. A major loophole the changes look to solve is foreign factories producing raw drug materials that stay completely invisible to the U.S. by routing the products through intermediate facilities overseas.

“The FDA is proposing changes to our establishment registration regulations that would reflect how distributed manufacturing actually works — as one single establishment,” Dr. Michael Davis, acting director of FDA’s Center for Drug Evaluation and Research, said in a statement.

“The proposed changes would make it easier for innovative manufacturers to operate efficiently, and give the FDA a clearer, more accurate picture of how and where drugs are being made,” he added.

THE OVERLOOKED REASON WHY NEW DRUGS TAKE SO LONG — AND THE $10 TRILLION FIX

The Food and Drug Administration is moving forward with a regulatory overhaul to limit U.S. reliance on drugs from foreign countries and cut red tape. (Sarah Silbiger/Getty Images / Getty Images)

“When an active ingredient in a medicine reaches an American patient, the FDA should be able to trace exactly where it came from,” said Davis. “Closing this registration gap for foreign establishments is a concrete step toward increasing the supply chain transparency that patients deserve.”

Officials say current regulations force American companies to register every single production unit as a completely separate factory. The new regulations will allow these to be streamlined into a single registration.

19 DRUG APPROVALS IN 2024 THAT HAD ‘BIG CLINICAL IMPACT,’ ACCORDING TO GOODRX

FDA Commissioner Dr. Marty Makary joins ‘Mornings with Maria’ to discuss the agency’s push to fast-track life-saving drugs, crack down on copycat weight-loss treatments and deliver faster cures without compromising safety.

The website will also provide tracking on the progress of the FDA’s other anti-red tape 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 offer eligible seniors access to Lilly weight loss medications for $50 a month beginning July 1.

CLICK HERE TO GET FOX BUSINESS ON THE GO

TrialBlazer seeks to boost the development of new drugs in the U.S. by relying more on computation during the development and approval process as well as allowing more flexible rules for clinical trials.

The pilot program seeks to help U.S. companies build manufacturing facilities in the U.S.

Source link

tags

Abkhazia Afghanistan Africa Albania Algeria Andorra Angola Antigua and Barbuda Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bhutan Bolivia Bosnia and Herzegovina Botswana Brazil Brunei Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Central African Republic Chad Chile China Colombia Comoros Costa Rica Croatia Cuba Curacao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic East Timor Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Eswatini Ethiopia Fiji Finland France French Polynesia Gabon Gambia Georgia Germany Ghana Greece Grenada Guam Guatemala Guinea Guinea-Bissau Guyana Haiti Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Israel Italy Jamaica Japan Jordan Kazakhstan Kenya Kiribati Kosovo Kuwait Kyrgyzstan Laos Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macau Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Mauritania Mauritius Mexico Micronesia Moldova Monaco Mongolia Montenegro Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria North Korea North Macedonia Northern Cyprus Norway Oman Pakistan Palau Palestine Panama Papua New Guinea Paraguay Peru Philippines Poland Portugal Puerto Rico Qatar Republic of the Congo Romania Russia Rwanda Saint Kitts and Nevis Saint Lucia Saint Vincent and the Grenadines Samoa San Marino Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Korea South Sudan Spain Sri Lanka Sudan Suriname Sweden Switzerland Syria Taiwan Tajikistan Tanzania Thailand Togo Tonga Transnistria Trinidad and Tobago Tunisia Turkey Turkmenistan Tuvalu Uganda UK Ukraine United Arab Emirates Uruguay USA Uzbekistan Vanuatu Vatican City Venezuela Vietnam Western Sahara Yemen Zambia Zimbabwe