The pharmaceutical landscape is changing—and it’s happening quickly. Sweeping policy shifts and landmark court decisions are fundamentally reshaping the regulatory environment, creating both strategic risks and untapped opportunities for industry leaders.
The coming months will separate market leaders from followers. The distinction will come down to a willingness to adapt.
So, how do you position your organization to capitalize on policy changes rather than simply reacting to them? Through proactive practices. Actions like scenario planning, investing in talent management, refining market strategies, and reimagining compliance as a competitive advantage will enable companies to navigate uncertainty and seize opportunities their competitors miss.
Part one of this series details three critical shifts reshaping pharma today, with three critical shifts to watch.
The US Supreme Court has changed its stance on deferring to federal agencies like the FDA. In a significant ruling on June 28, 2024, the Supreme Court overturned the Chevron deference doctrine. This doctrine, established in 1984, required courts to defer to federal agencies' interpretations of ambiguous laws if those interpretations were reasonable.
With the Chevron deference no longer in place, courts may now rely on their own interpretations of ambiguous laws rather than deferring to agencies like the FDA. This shift is expected to have wide-ranging impacts on how federal regulations are interpreted with potential implications for pharmaceuticals pertaining to off-label marketing amongst others. With the Supreme Court’s decision, varying levels of enforcement and interpretation of regulations are expected to take place across different states depending on respective political party control.
Pharmaceutical companies can adopt several strategies to navigate the new regulatory landscape following the Supreme Court's decision to overturn Chevron deference:
This new regulatory landscape allows companies to take a more aggressive approach to developing new therapies. It will also make it possible for pharma companies to work with the FDA on equal footing to support the development of new therapies. This has already opened new opportunities in the 340B space which can affect reimbursement and the Laboratory Developed Test space. Capitalizing on these opportunities requires substantial organizational change management to realign regulatory affairs teams with a more proactive stance. Companies that successfully navigate this cultural and operational transformation will position themselves to extract maximum value from the new regulatory environment while competitors struggle with implementation.
The administration's emphasis on rare diseases and advanced therapies, such as gene and cell treatments, is likely to persist. During Trump's first term, there was a record number of drug approvals for rare diseases, thanks to incentives like the Orphan Drug Act.
Resulting appointments within the administration has additionally led to some pharma organizations reshuffling their portfolio effort in response. This is likely to result in the challenge of increased scrutiny on the misuse of orphan drug incentives, as well as ensuring these benefits primarily support smaller biotech firms.
With orphan drug approvals expected to accelerate and scrutiny intensifying simultaneously, pharmaceutical companies must recalibrate their rare disease approach. The most successful organizations will implement these targeted strategies:
Renewed focus on rare diseases presents strategic inflection points. Organizations who are leaders in specific rare disease areas have a unique opportunity to attract investment through acquisition or further partnership opportunities.
Meanwhile, the reshuffling of portfolios in response to administrative changes presents an opportunity for companies to reassess and optimize their research focus, potentially leading to more efficient resource allocation and improved long-term strategy. These shifts make it critical to realign—if not reimagine—their operating model so that it is built to support faster decision-making. Companies that are able to manage this transition effectively will capture market share while also creating meaningful patient impact.
On February 10th 2025, an executive order was issued pausing the enforcement of the Foreign Corrupt Practices Act (FCPA) for 180 days. This decision aims to address concerns that the FCPA's enforcement has become overly expansive and unpredictable, creating an uneven playing field for U.S. companies competing internationally
The pause is intended to promote American economic competitiveness and prioritize national security interests. However, it has sparked debate about the potential risks of reduced anti-corruption enforcement and its impact on global business ethics.
This 180-day enforcement pause creates a deceptive compliance trap for pharmaceutical companies operating globally. Smart leaders will reject short-term compliance shortcuts in favor of these strategic approaches:
Pausing enforcement of the FCPA has provided pharmaceuticals with reduced immediate legal pressure and operational flexibility when operating in the US. But with the pause only for 180 days, there is a challenge to anticipate what will happen in the second half of 2025 and beyond especially in the context of the OECD Anti-Bribery Convention that establishes legally binding standards.
Furthermore, the rapid elimination of DOJ attorneys and a reshuffle of priorities may mean that the impact may last past the first 180 days.
This temporary enforcement pause creates a strategic window for pharmaceutical companies to reassess and strengthen their global compliance frameworks. Effectively capitalizing on this opportunity requires coordinated change management across multiple business functions, from legal and compliance to sales and market access. Companies that use this period to implement more efficient compliance processes—rather than simply relaxing standards—will be able to sustain competitive advantage when enforcement inevitably resumes.
Regulatory upheaval creates both challenges and opportunities for pharmaceutical companies. The Supreme Court's reversal of Chevron deference introduces regulatory uncertainty but also opens doors for more direct engagement with the FDA. Meanwhile, the Trump administration's focus on rare diseases demands strategic portfolio adjustments. Forward-thinking companies will embrace collaborative partnerships and innovative approaches to navigate this changing landscape. In our next installment, we'll explore operational implications and strategic responses to complete the picture of pharmaceutical industry adaptation under the new administration.