The impact of the new government’s policies on the U.S. regulatory landscape 

The regulatory landscape in the United States continues to shift under the new government, which secured re-election in 2024. The administration maintains its deregulatory agenda, reshaping oversight in key industries such as pharmaceuticals, healthcare, technology, and environmental protection. While these changes aim to drive economic growth and reduce bureaucratic hurdles, they also spark debates around safety, regulatory compliance, and long-term industry stability.

Deregulatory policies: cutting red tape

One of the administration’s key regulatory initiatives remains the “2-for-1” rule, requiring that for every new federal regulation introduced, two existing ones must be removed. This approach continues to lower compliance costs for businesses, particularly small enterprises and encourages economic expansion. However, critics argue that it places deregulation above consumer protection and industry accountability.

Additionally, the president of the United States has signed an executive order granting the White House greater control over independent agencies such as the Federal Election Commission and the Securities and Exchange Commission. These agencies must now submit major regulations for review by the Office of Management and Budget and appoint White House liaisons within their structures.

FDA and healthcare regulations

The Food and Drug Administration (FDA) is undergoing significant regulatory shifts during the administration’s second term. A key initiative focuses on accelerating drug approvals, allowing new treatments to reach the market more quickly. The FDA is streamlining its review processes, particularly through programmes designed to expedite medical product releases.

The administration is also intensifying efforts to lower pharmaceutical prices and increase market competition. New initiatives aim to revise pricing mechanisms and reduce reliance on imported medicines. However, recent restructuring efforts within federal agencies have led to significant staff reductions at the FDA and CDC, raising concerns about their ability to fulfil their public health responsibilities effectively.

WHO withdrawal and its impact on the regulatory landscape

The U.S. has now finalised its withdrawal from the World Health Organization (WHO), impacting international health coordination efforts. Federal agencies such as the FDA and CDC must now develop alternative frameworks for regulatory cooperation. The departure from WHO raises concerns about how effectively U.S. public health agencies can respond to global health crises and maintain alignment with international standards.

Impact of WHO withdrawal on ISO 13485 and FDA harmonisation

One major consequence of the withdrawal is the potential slowdown in aligning ISO 13485 with FDA regulations. ISO 13485 is an internationally recognised quality management standard for medical devices, while the FDA follows its own regulatory framework (21 CFR Part 820). Efforts to bring these standards closer together were previously supported through international collaboration, including WHO involvement and the International Medical Device Regulators Forum (IMDRF).

Without WHO coordination, the U.S. must establish alternative mechanisms to engage with global regulators. This shift may result in:

• Diverging regulatory requirements makes it harder for U.S. manufacturers to access international markets.
• Increased compliance costs, as companies must adapt to multiple standards.
• Slower certification and approval processes for U.S.-developed medical devices.

Some analysts predict that the FDA may tighten domestic regulatory requirements to compensate for the lack of international coordination. However, this could introduce additional barriers for companies trying to comply with both U.S. and European standards.

Trade and economic regulations

The administration continues to pursue protectionist trade policies, expanding tariffs on foreign manufacturers. This impacts international supply chains and import regulations, prioritising domestic manufacturing and revising trade agreements. The government has also pushed for stricter domestic manufacturing requirements in key industries, including pharmaceuticals, semiconductors, and energy.

Technology and data privacy regulations

The current administration remains firm on regulating the technology sector. Planned amendments to Section 230 of the Communications Decency Act aim to reduce legal protections for online platforms. Meanwhile, evolving data protection policies focus on national security concerns and reducing foreign influence in the tech sector.

A significant shift came when the president signed an executive order revoking previous artificial intelligence (AI) regulations, signalling a new approach to AI governance. This decision is expected to shape innovation policies, particularly in areas such as AI ethics, national security applications, and global competition in emerging technologies.

Summary

The new U.S. administration’s regulatory shifts prioritise economic growth and national security but bring challenges in compliance, international trade, and public health oversight. Businesses must stay agile, adapting to evolving standards in healthcare, technology, and trade while preparing for potential regulatory divergence. Companies operating globally should establish alternative compliance strategies, monitor changes in FDA and data privacy rules, and anticipate shifts in trade policies. Proactive engagement with industry groups and regulatory bodies will be key to navigating this changing landscape and ensuring long-term stability in an increasingly complex regulatory environment.