US President Trump has signed an executive order to catalyse “regulatory relief” for drug manufacturers from the FDA.
The new order states that it aims to establish a domestic, resilient, and affordable pharmaceutical supply chain for American patients.
To this end, the executive order highlights the construction of pharmaceutical manufacturing facilities as a bottleneck to this goal, stating that the industry estimate is 5-10 years to build new facilities and critical inputs.
The order points to the “myriad Federal, State, and local requirements ranging from building standards and zoning restrictions to environmental protocols” as the culprit to this.
To address this stated problem, the order suggests “regulatory relief”, specifically from the FDA.
“It is in the best interest of the Nation to eliminate regulatory barriers to the domestic production of the medicines Americans need,” the order states.
For foreign facilities, the order encourages the opposite approach from that for domestic ones: it promotes increasing inspection frequency
The order directs the FDA Commissioner to review all regulations and guidance that apply to the inspection and approval of new and expanded manufacturing capacity, as well as emerging technologies.
The order specifically lists out many FDA tasks that should be looked at, such as reducing inspection frequency.
The reasoning stated within this order is
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