President Donald Trump signed an executive order on Monday to restore a "robust" medicine manufacturing base in the United States by streamlining regulation around the development of domestic pharmaceutical manufacturing.
"It is in the best interest of the Nation to eliminate regulatory barriers to the domestic production of the medicines Americans need. My Administration will work to make the United States the most competitive nation in the world for the manufacture of safe and effective pharmaceutical products," the order, titled "Regulatory Relief to Promote Domestic Production of Critical Medicines," stated.
The order directs the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, to review existing guidance and regulations regarding the development of domestic pharmaceutical manufacturing, and to take steps to "eliminate any duplicative or unnecessary requirements in such regulations and guidance; maximize the timeliness and predictability of agency review; and streamline and accelerate the development of domestic pharmaceutical manufacturing."
The order also directs the Environmental Protection Agency to review and streamline regulations and guidance related to the inspection and approval of new and expanded manufacturing capacity of pharmaceutical products, and the Army Corps of Engineers to review nationwide permits "to determine whether an activity-specific nationwide permit is needed to facilitate the efficient permitting of pharmaceutical manufacturing facilities."
Additionally, the order directs the FDA Commissioner to develop and advance improvements to routine reviews of overseas manufacturing facilities that are involved in the production of US medicines, and ordered that the commissioner publicly disclose the number of inspections undertaken each year on such facilities.
In early April, Trump announced that major tariffs on pharmaceuticals from foreign countries would be forthcoming. Around 90% of all antiviral and antibiotic drugs used by Americans are made with ingredients sourced overseas.
