Action: On May 5, the President signed an Executive Order seeking to promote domestic manufacturing of prescription drugs. The Order directs the Food and Drug Administration (FDA) to reduce the approval times associated with pharmaceutical manufacturing capacity including new and expanded manufacturing sites, “emerging technologies,” key starting materials, and associated raw materials. The Order includes a review of the FDA’s licensure, inspection, and enforcement apparatus in favor of accelerated timelines and reduced regulations. Under the Order, the FDA Commissioner must also assess the current inspection regime of manufacturing facilities involved in the US medicine supply, with a particular focus on foreign facilities. The Order also directs the Environmental Protection Agency (EPA) to issue new guidance reducing regulatory barriers associated with the construction of relevant facilities and better coordinate the permitting process for these facilities with relevant agencies. This process will be centralized through the White House Office of Management and Budget (OMB).Key Insights
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