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.
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“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.
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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.
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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.
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