The Impact of Presidential Executive Orders on the Pharmaceutical and Medical Devices sectors in the USA

Recent developments in United States (US) healthcare regulation have brought significant changes to the process of approving pharmaceutical products and medical devices.

The present administration’s latest Executive Orders, aimed at reforming the Food and Drug Administration (FDA), combined with the actions of the newly established Department of Government Efficiency (DOGE), are reshaping how pharmaceutical products, medical devices and medical innovations are evaluated and approved by the FDA

From accelerated approval pathways to domestic manufacturing mandates, these reforms are poised to redefine the industry’s operational and strategic priorities. However, they have sparked debate over their broader implications for public health, industry competitiveness, and regulatory integrity.

Regardless of the political impact of these decisions, it is crucial to understand the effects of these reforms on pharmaceutical and medical device stakeholders.

This article therefore explores the key provisions of the executive orders, the role of DOGE, and the potential impacts on FDA processes, clinical studies, and global market dynamics. The below analysis seeks to help pharmaceutical and medical device stakeholders navigate the evolving landscape and prepare for both opportunities and challenges ahead.

1. Executive Orders and their impacts

To date, a total of 89 Executive Orders have been signed by the present presidential administration, including 18 Executive Orders directly impacting the FDA, the FDA’s functions and the Life Sciences industry in general.

The Executive Orders focus on expediting the FDA’s approval processes and reducing bureaucratic hurdles. Key provisions include:

1. Accelerated Approval Pathways: The Orders emphasize the need for faster review processes, particularly for breakthrough therapies and medical devices addressing urgent health needs.
2. Simplified Regulatory Frameworks: The FDA is directed to reduce the complexity of clinical trial requirements, allowing for greater flexibility in trial designs and reliance on real-world evidence.
3. Promoting Competition: By encouraging the approval of generic drugs and biosimilars, the Orders aim to increase competition and reduce healthcare costs for consumers.
4. Emergency Use Authorizations (EUAs): The Orders empower the FDA to grant EUAs more rapidly during public health emergencies, ensuring timely access to critical medical products.

The effects of the Executive Orders are expected to be amplified by the initiatives of the newly established Department of Government Efficiency (DOGE), which has been tasked with identifying inefficiencies across federal agencies and implementing strategies to enhance operational effectiveness.

2. The Role of the Department of Government Efficiency (DOGE)

DOGE, established as part of the President’s broader administrative reforms, has taken several actions to streamline the FDA’s approval process for pharmaceutical products and medical devices (Executive Order 14158: Establishing and Implementing the President’s DOGE).

The combined effects of the Executive Orders and DOGE’s actions are expected to have significant implications for the FDA’s approval processes including faster approvals, cost reductions, increased innovation and improved efficiency.

While it is too soon to presently assess the positive and negative impacts of these Executive Orders and DOGE activities on the Life Sciences industry, several widely acknowledged impacts have been highlighted by various FDA representatives, experienced lawyers, and industry leaders when interviewed.

2.1       Promotion of Domestic Manufacturing

Executive Order 14273 (Lowering Drug Prices by Once Again Putting Americans First”) focusses on ensuring that essential medicines, medical countermeasures, and critical inputs such as active ingredients are made in the US. This initiative aims to reduce dependency on foreign manufacturing and strengthen the domestic supply chain, potentially leading to greater security and reliability in the availability of medical products.

Due to the increased borders tax on pharmaceutical products and medical devices, foreign companies may consider relocating their US market production to the US and/or partnering with a local Contract Manufacturing Organization (CMO) to transfer their manufacturing operations. Moving production activities to the US involves submitting a dossier to the FDA for approval and may require a Pre-Approval Inspection (PAI) , if necessary. If production is moved to a local CMO, the transferring company should conduct an audit of the CMO to ensure product quality and that manufacturing activities have been successfully transitioned.

2.2       FDA workforce reduction impacts

DOGE has conducted audits of FDA workflows to identify bottlenecks and redundancies in the approval process. It has also advocated the use of advanced technologies, such as artificial intelligence and machine learning, to assist in the evaluation of clinical trial data and expedite decision-making (Executive Order 14179: Removing Barriers to American Leadership in Artificial Intelligence). Consequently, more than 3500 FDA employees have been laid off or encouraged to “find new opportunities in the private sector”. This workforce reduction accounts for more than 20% of the agency’s total staff. Additionally, the new Executive Order (14274) on Return to In-Person Work instructs the heads of all federal departments and agencies to “take all necessary steps to terminate remote work arrangements and require employees to return to in-person work at their respective duty stations on a full-time basis.” This may create employee retention challenges for the FDA; it also restricts the FDA to hire talent only in regions where FDA offices are located.

If the FDA’s Center for Devices and Radiological Health (CDRH) experiences a significant loss in employees, key medical device regulatory functions are likely to be adversely impacted, including the timely review of medical device premarket submissions due to the 20% staff reduction, provision of feedback through the Q-submission program, and the issuance and finalization of new or updated guidance and regulations, among others. It becomes increasingly important to submit good quality dossiers as the timeline for reviewing multiple responses to FDA deficiency letters may increase.

Conversely, the Executive Orders’ insistence on greater efficiency may place undue pressure on FDA personnel encouraging FDA reviewers to take rushed decisions as long as the safety of the product is demonstrated, potentially leading to increased recalls, legal and financial consequences for manufacturers, and in the worst-case scenario, to the erosion of public trust in the FDA and medical device industry.

2.3       Regulatory and communication freeze

Executive Order 14192 (Unleashing Prosperity Through Deregulation) prevents the FDA from issuing or proposing new rules until reviewed and approved by an appointed agency head.

This freeze will delay any pending or planned rules by the FDA. For instance, rulemaking required to implement new device classifications resulting from de novo authorizations would be impacted by the Executive Order.

This Executive Order also impacts rules that were previously published and finalized but have not yet taken effect, including recently finalized FDA rules impacting medical devices, such as the final rule for laboratory-developed tests and the final rule to update the Quality System Regulation (21 CFR Part 820) to align with ISO 13485:2016. The current administration also issued a temporary order to federal health agencies, including the FDA, to temporarily pause external communications. Consequently, the FDA stopped any public appearances that are not related to emergencies or critical to preserving health.

The directive to pause communications introduces potential short-, medium-, and long-term implications, particularly for industries that depend on timely updates regarding product approvals, recalls, enforcement reports, and other routine notices. A prolonged communication freeze could disrupt business operations, especially for companies awaiting competitor clearances or authorizations through the de novo process to proceed with their own device submissions via a Traditional 510(k) predicated on the accepted de novo clearance. Smaller companies are especially vulnerable, as delays in publishing marketing authorizations could jeopardize their ability to sustain operations, potentially leading to closures.

Finally, the directive to pause communications also raises concerns about the potential impact on the overall quality of pre-submission meetings. With FDA reviewers reluctant to provide detailed insights into the agency’s current vision, initiatives, or future guidance, their responses may become overly generic to avoid the risk of being accused of sharing unauthorized information. This shift could hinder meaningful dialogue between the FDA and industry stakeholders, complicating the regulatory process and leaving companies with less clarity on how to align their submissions with evolving FDA expectations.

2.4       Clinical studies

Conducting clinical studies is essential to evaluate the safety, efficacy, and quality of medical products, ensuring they meet regulatory standards and effectively address patient needs. Executive Order 14192 (Unleashing Prosperity Through Deregulation) and Executive Order 14151 (Ending Radical and Wasteful Government DEI Programs and Preferencing) have two major impacts on clinical studies: 1) an increased ability to leverage real-world data to justify clinical benefit and safety, and 2) a reduction in the need for diversity in clinical study protocols.

Historically, the FDA has been reluctant to accept non-US studies or those conducted in accordance with external standards or guidance rather than their own. However, this stance has been significantly challenged in recent months. FDA reviewers are now under increasing pressure to consider clinical studies conducted according to practices and standards not published by the FDA, provided that the sponsor can justify their use.

Previously, FDA reviewers consistently referenced their own guidance during pre-submission meetings with sponsors. This approach has started to shift, as FDA reviewers now indicate that “the FDA is willing to consider alternative approaches”. Whether the agency will consistently accept these alternatives remains to be seen, but this evolving position could create new opportunities for sponsors seeking regulatory approval.

The second impact on clinical studies comes from the Executive Order calling on federal agencies to end diversity, equity and inclusion (DEI) programs and to revise all policies and documents containing DEI-related topics. In response, the FDA removed from its website several potentially DEI-related draft guidance documents mandated by the 2022 Food and Drug Omnibus Reform Act (FDORA), including one on clinical trial diversity action plans, another on evaluating sex-specific and gender-specific data in medical device clinical studies, and draft guidance on standards for collecting race and ethnicity data in clinical trials. These DEI-related guidance documents highlighted the need to gather sub-population data for some medical products to ensure their safety and effectiveness for diverse groups. Their removal raises questions about the future of efforts to address health disparities in clinical research and product development.

For European manufacturers, greater consideration for real-world evidence and the removal of DEI concerns could have a potentially positive impact. It provides them with a greater opportunity to present European-sourced data and utilize data collected from products already distributed and available on the European market.

2.5       Withdrawal from the WHO

Executive Order 14155 (Withdrawing the United States from the World Health Organization) (WHO) may have implications for FDA/CDRH initiatives in which the WHO is a participant or collaborator, though it is unclear at this time what the full impact may be on these activities.  

These initiatives include the Medical Device Single Audit Program (MDSAP), which is intended to foster a global approach to auditing and monitoring the manufacturing of medical devices; the International Medical Device Regulators Forum (IMDRF), an initiative intended to harmonize regulatory requirements for devices that may vary across countries; and Medical Device Connectors, an effort by FDA to collaborate with stakeholders to promote development of connectors that reduce the risk of device misconnections.

2.6       Impact on AI Policies

Executive Order 14179 (Removing Barriers to American Leadership in Artificial Intelligence) rescinds several Executive Orders issued by former President Joe Biden, including Executive Order 14110 on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, which outlined principles for the oversight of artificial intelligence (AI) across government agencies, including the FDA. The Executive Order requires a review of all policies, directives, regulations, orders, and other actions taken pursuant to the revoked Executive Order 14110 and will affect several FDA guidance documents and other resources related to AI. These modifications could potentially remove AI-related restrictions in the long term but would require the FDA to modify a significant number of guidance documents in the short term. For example, the FDA used definitions from Executive Order 14110 in the final guidance for Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions and the cross-center discussion paper on AI and medical products. The FDA also uses many of the definitions from Executive Order 14110 in the online FDA Digital Health and Artificial Intelligence Glossary – Educational Resource. Those definitions were cross-referenced in the more recent draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.

The FDA will have to review and update the aforementioned guidance documents, impacting the clearance of new AI-based products.

3. Future impacts

The latest Executive Orders signed by the current presidential administration and the actions of the DOGE represent a significant shift in the FDA’s approach to regulating pharmaceutical products and medical devices. While these measures hold promises for improving efficiency and fostering innovation, they also raise important questions about safety, efficacy, and equity.

The key challenge lies in achieving a balance between enhancing efficiency and upholding the FDA’s gold standard for safety and efficacy. While the Executive Orders and DOGE’s initiatives aim to address urgent needs and reduce barriers, it is crucial to ensure that the integrity of the approval process is not compromised. Transparent guidelines, robust post-market surveillance, and ongoing stakeholder engagement will be essential to achieving this balance.

As the healthcare industry adapts to these changes, it will be critical to monitor outcomes closely and prioritize patient well-being above all else. The coming years will reveal whether these reforms succeed in delivering the intended benefits or if further adjustments are needed to safeguard public health.

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Need help navigating US registration procedures or assessing the impact of current political decisions on your product’s time to market? Contact us at TechnicalDivision@efor-group.com for the following services:

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