This executive order aims to boost U.S. drug manufacturing, reduce reliance on foreign supply chains, and shorten facility approval timelines. It may lower regulatory burdens, but could also shift costs and oversight practices, affecting domestic and international manufacturers alike. While this may allow for drugs to be more reliably available, improving access, there are also potential pitfalls. As it typically costs more for domestic production, it will be important to ensure that prices for drugs produced domestically are affordable to patients. Manufacturing also often brings environmental impacts that may lead to poorer health outcomes, often more heavily concentrated in low-income communities and communities of color. It will be critical to ensure that these groups are not bearing the brunt of the health impacts.
A directive issued by the President that manages operations of the federal government. Executive orders have the force of law but must align with existing statutes and constitutional authority.
Who It Impacts: Federal agencies and employees, directing them on how to implement laws or carry out government functions. Executive orders can also influence businesses and individuals when they relate to issues like immigration, trade, or labor policies.
Who Is Not Impacted: Private citizens and businesses do not have to directly follow an executive order unless it leads to regulations or policies that apply to them. For example, an executive order directing federal agencies to increase renewable energy use does not mandate action from private companies, but it may influence policy shifts that eventually affect them.
Summary
An executive order directing key federal agencies to streamline regulations and oversight to encourage domestic pharmaceutical manufacturing. The Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and Army Corps must revise regulatory requirements, eliminate duplicative barriers, accelerate inspections and permitting, and enhance foreign facility oversight to strengthen U.S. production capacity for critical medicines.
Impact Analysis
Legal Challenges
While there are no widely reported lawsuits, stakeholders could challenge streamlined permitting or reduced environmental review under the National Environmental Policy Act (NEPA) or Environmental Protection Agency (EPA) rules if procedural safeguards are bypassed.
Take Institutional Action
- Healthcare professionals and community-based organizations can partner with the FDA, state health departments, and industry coalitions to support domestic manufacturing initiatives that include quality assurance, workforce development, worker health, environmental protection, and patient access planning.
- Healthcare professionals, community-based organizations, and individual advocates can submit feedback and provide public comment during rulemaking periods implementing the executive order’s directives.
Associated or Derivative Policies
Policy Prior to 2025
N/A
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