Summary
The White House recently announced two major initiatives addressing healthcare and national security: one to boost domestic production of critical medicines, and another to improve the safety of biological research. Below we break down the goals of each initiative, the actions being taken, and why they are significant.
Promoting Domestic Production of Critical Medicines
The White House is pushing to see more state-of-the-art pharmaceutical manufacturing facilities within the United States to strengthen the supply of essential medicines. On May 5, 2025, the President signed an Executive Order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines.” The goal of this order is to strengthen America’s ability to manufacture essential drugs domestically, including important prescription medications and their key ingredients, so that the U.S. is less dependent on foreign suppliers.
In recent years, events like the COVID-19 pandemic have highlighted risks in relying on overseas sources for medical supplies. By building a robust domestic manufacturing base for pharmaceuticals, the administration aims to ensure a stable supply of medicines for Americans and reduce vulnerabilities in our supply chain.
Key Actions in the Executive Order Include:
- Fast-Tracking U.S. Drug Facilities: The Food and Drug Administration (FDA) is directed to expedite the approvals for new American drug manufacturing facilities. This includes eliminating unnecessary regulatory hurdles and streamlining review processes to accelerate facility openings. Additionally, the FDA will even provide early technical support to companies to help them address compliance issues before facilities become operational, thereby reducing delays in production.
- Tougher Oversight of Foreign Producers: To level the playing field, the FDA will increase inspections of overseas pharmaceutical facilities and impose higher fees on foreign manufacturers. The agency will also crack down on foreign companies that fail to disclose where they source their active ingredients and may publicly list facilities that fail to meet U.S. safety standards. This is to ensure imported drugs meet safety requirements while also encouraging domestic production.
- Streamlined Permitting for Factories: The Environmental Protection Agency (EPA) and other agencies (such as the Army Corps of Engineers) are tasked with expediting the permits and construction approvals for new drug production facilities. To do this, the order is setting up a “one-stop” permitting process, requiring agencies to designate a single point of contact to coordinate all the necessary permits. The White House Office of Management and Budget (OMB) will oversee this process to ensure efficiency and prevent unnecessary delays.
Why It Matters
These measures are designed to shorten the time it takes to build or expand pharmaceutical facilities in the United States, which currently can take 5 to 10 years under complex regulations. Faster, simpler approvals mean critical medicine production can ramp up more quickly in emergencies.
The administration frames this as not just an economic issue but as a matter of national security. The President emphasized the importance of self-reliance in pharmaceutical manufacturing, stating, “We don’t want to be buying our pharmaceuticals from other countries because if we’re in a war or in a problem, we want to be able to make our own”.
By investing in domestic production, the U.S. can ensure secure and reliable access to medicines for its citizens and create jobs in the process. Overall, this initiative reinforces an “America First” strategy in the pharmaceutical sector, building on earlier efforts to bring medical supply chains back home.
Improving the Safety and Security of Biological Research
The White House’s new directive seeks to ensure that high-risk biological research is conducted with strong safety measures. On May 5, 2025, the White House issued a National Security Memorandum focused on Improving the Safety and Security of Biological Research. This initiative is a response to the growing concerns about gain-of-function research, a type of research in which scientists enhance the contagiousness or lethality of viruses or other pathogens. Such experiments can be valuable in helping develop vaccines and treatments, but if not managed correctly, they could potentially lead to outbreaks.
The new memorandum’s goal is to tighten oversight on this kind of research so we can reap scientific benefits without endangering public health. In short, the administration wants to prevent lab accidents or misuse of research that might lead to the next pandemic, while maintaining U.S. leadership in biotechnology and innovation.
Key Steps in This Biosafety Initiative Include:
- Cutting Off Funding for Risky Research Abroad: Effective immediately, federal agencies are ordered to stop funding “dangerous” gain-of-function studies in countries that lack strict safety oversight. This means that U.S. government funds will no longer support high-risk virus research in nations like China or other countries of concern, unless they adhere to the same rigorous safety standards enforced domestically. The intent is to prevent American tax dollars from financing potentially hazardous experiments overseas
- Pausing Certain Experiments at Home: The directive also calls for a suspension of ongoing high-risk biological research in the U.S., such as work that could potentially enhance pathogen virulence, until more stringent safety regulations are developed and implemented. If a federally funded project is deemed especially risky, it should be put on hold for now. This pause provides the necessary time to update protocols and ensure future research continues under enhanced safety measures.
- Updating Safety Rules and Oversight: The White House Office of Science and Technology Policy (OSTP) has been given 120 days to develop new, more stringent guidelines for life science research that poses significant risks. These updated regulations aim to enhance independent oversight of experiments and require more transparency and accountability. For example, scientists conducting potentially high-risk studies may be required to publicly disclose their activities, adhere to stricter safety protocols, and undergo regular audits. Non-compliance with these regulations could result in penalties.
- Monitoring Non-Federally Funded Research: The new plan extends beyond government-funded laboratories to include privately funded and academic research facilities. Within 180 days, the administration will develop a strategy to monitor high-risk biological research conducted outside the federal funding framework. If there are gaps in legal authority to regulate such private research, the White House will propose new legislation to address them.
- Enforcing Compliance and Transparency: To strengthen enforcement, research institutions receiving federal grants will now be required to certify that they are not engaged in any prohibited gain-of-function work, especially abroad. Violators will face immediate suspension of federal funding and may be prohibited from obtaining new grants for up to five years. Furthermore, the new policy will implement public reporting mechanisms, allowing for Americans to have access to information about approved high-risk research and projects that are halted for safety reasons. This increased transparency aims to build public trust that high-risk research is conducted responsibly and safely.
Why It Matters
This memorandum represents a major tightening of biosecurity policy in the wake of COVID-19. It directly addresses concerns that insufficient oversight or accidental leaks from laboratories could trigger outbreaks. By halting funding for potentially unsafe experiments and mandating stricter controls, the administration is trying to prevent “the next pandemic” from originating in a lab accident.
Previous guidelines relied heavily on researchers to self-report and follow honor systems. The new directive introduces enforceable rules with concrete consequences, striking a balance between scientific freedom and public safety. Researchers can continue critical work on vaccines and treatments, but under more rigorous oversight.
In the long run, these actions aim to protect Americans from biological threats while maintaining the nation’s leadership in biotech innovation. By learning the lessons of past biosafety lapses and the pandemic, the U.S. is strengthening its guardrails for cutting-edge biological research, an investment in both our health security and scientific future.
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