By the authority vested in him as President by the Constitution and the laws of the United States, an executive order has been issued to enhance domestic production of critical pharmaceutical products. The initiative aims to address regulatory barriers that hinder the development of a resilient and affordable pharmaceutical supply chain in the U.S.
The President's administration previously directed efforts through Executive Order 13944, dated August 6, 2020, to boost domestic procurement of essential medicines and identify vulnerabilities in national supply chains. However, significant challenges remain due to prolonged timelines for constructing pharmaceutical manufacturing facilities domestically.
One concern highlighted is the extensive regulatory process required for building new facilities or modifying existing ones. "Industry estimates suggest that building new manufacturing capacity for pharmaceuticals and critical inputs may take as long as 5 to 10 years," which is considered unacceptable from a national security perspective.
The new policy aims to streamline regulations related to pharmaceutical manufacturing. Within 180 days, the Secretary of Health and Human Services, through the FDA Commissioner, will review current regulations and eliminate unnecessary requirements. The focus will be on ensuring inspections are efficient and only necessary for compliance with federal laws.
Additionally, improvements will be made in enforcing data reporting under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act. Clearer guidance will also be provided for site changes and validation of components necessary for manufacturing.
To ensure overseas manufacturing facilities meet standards equivalent to those in the U.S., enhancements will be made to their inspection regime within 90 days. This includes increasing fees on foreign facilities where applicable by law.
The Environmental Protection Agency (EPA) will update its regulations within 180 days to eliminate duplicative requirements related to environmental inspections and approvals. It will also coordinate environmental permits centrally for pharmaceutical manufacturing facilities requiring an Environmental Impact Statement.
Further reviews are planned by the United States Army Corps of Engineers regarding nationwide permits under section 404 of the Clean Water Act and section 10 of the Rivers and Harbors Appropriation Act. These actions aim at facilitating efficient permitting processes.
In conclusion, this order intends not only to strengthen national security but also positions America as a competitive hub for safe pharmaceutical production globally.
