Biden’s Legacy; Trump’s Agenda: Part 1

As with any new government, change is inevitable. When Joseph R. Biden handed over the keys to the White House to new POTUS Donald J. Trump, however, changes have perhaps come faster than expected. We spoke to four pharma leaders to get their perspectives on Biden’s legacy and the unpredictability of Trump’s second term. 

In part 1 of this discussion, our thought leaders focus on what to expect and how to work around the changes to come. 

Meet the experts 

What major impact policies were actioned during Biden’s presidency?
 

Stella Vnook: The Biden/Harris administration focused on expanding healthcare access, lowering drug prices, and increasing government involvement in pharmaceutical pricing through policies such as the Inflation Reduction Act. Biden also prioritized pandemic response efforts, vaccine distribution, and investment in biomedical research, particularly through the Advanced Research Projects Agency for Health (ARPA-H). The administration aimed to control healthcare costs through Medicare negotiations, which had both supporters and critics in the industry.  

Ali Pashazadah: The Inflation Reduction Act had a significant impact on healthcare. The Act marked a major trade-off between recognizing both the spiraling costs of innovative therapies for payers and patients, and the potential to seek reimbursement for the investment from developers.   

The most controversial policy, however, is the BioSecure Act. When closely examined, this was narrow in its focus and had far major implications in that a significant number of players moved away from Chinese manufacturers, such as WuXi Biologics. This also led to a lot of soul-searching with a new direction of travel, away from the globalization of drug development.  

Audrey Greenberg: The Biden/Harris administration's impact on cell and gene therapy (CGT) was a mixed bag. While the Centers for Medicare and Medicaid Innovation piloted reimbursement models for sickle cell therapies – an encouraging move toward enabling broader access – policy uncertainties loomed large. The Cancer Moonshot 2.0 initiative reignited funding into CAR-T and AI-driven oncology, reinforcing the administration’s pro-research stance. The Inflation Reduction Act (IRA) introduced significant drug pricing reforms, but its impact on CGT is still evolving. The IRA threw a curveball at CGT investors – some see an opportunity, while others see a warning sign. The industry is still deciding whether to lean in or pull back, as the long-term effects on pricing and investment strategies remain uncertain.

Priya Baraniak: The American Rescue Plan Act provided substantial funding for public health, including testing, vaccination, and support for healthcare providers, which helped mitigate the impacts of the COVID-19 pandemic. Its emphasis on expanding Medicaid coverage in several states significantly contributed to increased access to healthcare for millions. This was coupled with a focus on rebuilding the public health infrastructure including investments in the Centers for Disease Control and Prevention (CDC) and the healthcare workforce, aiming to enhance preparedness for future health crises. Of course, the BioSecure Act stands out in its heated response from legislators and the industry. While it reflected a significant policy shift aimed at strengthening the US healthcare system's resilience, it raises significant concerns about globalization, innovation, and pricing for novel treatments.

How do you think Joe Biden will be remembered by the industry? 
 

Vnook: Biden will likely be remembered for his push to reduce prescription drug costs and expand Medicare's ability to negotiate prices. While this was framed as a win for patients, there are concerns that such policies could reduce R&D investments and slow down innovation, particularly in high-risk biotech ventures. His administration's focus on government-driven healthcare initiatives was seen as both a stabilizing force and a potential barrier to free-market competition.  

Pashazadah: Biden will likely be remembered as a steady pair of hands. However, one criticism that can be justifiably levelled is that he really didn’t do very much to help the industry get back on its feet after the COVID-19 pandemic – which resulted in uncertainty in the biopharma sectors. Nor did he do much to improve the uncertainty that contributed to the investment slump we’ve seen over the last few years.    

Looking further back, there were very few revolutionary changes over the four-year period of Trump’s first term, but – for good or ill – Trump’s first two weeks of a second term were more memorable than the entire Biden era.  

Baraniak: Biden is likely to be remembered by the healthcare industry for his proactive approach to addressing the rising costs of healthcare and expanding access to innovative treatments. His efforts will likely be seen as pivotal steps toward making advanced therapies more accessible, which signaled a commitment to improving health outcomes and tackling inequities in healthcare access. Programs targeting maternal health, mental health, and substance abuse services were intended to mitigate disparities exacerbated by the pandemic. It is to be noted that the administration placed increased emphasis on mental health, particularly regarding access to mental health services during the pandemic, showing commitment through various programs aimed at integrating mental health care within primary care settings.

Biden’s emphasis on lowering drug costs will likely be viewed favorably, but his legacy in the industry might be shaped by the ongoing debates about the balance between innovation and cost control. His administration's actions will be remembered as a turning point in federal efforts to address these complex issues, marking a shift toward more inclusive and equitable healthcare policies.  

Greenberg: Biden’s legacy in the industry is a paradox; strong support for scientific advancements but a lack of clarity on long-term commercial viability. His investments in biomanufacturing and regulatory modernization laid the groundwork for future breakthroughs, but the IRA  introduced uncertainty around drug pricing. While some argue that the extended exclusivity period for biologics could be favorable, others worry that future pricing constraints may dampen innovation. The long-term impact remains uncertain, and investors and developers continue to reassess their pricing and development strategies.  

Trump is making wholesale changes. What were the big impacts of his first presidency, and what can we expect going forward?
 

Greenberg: Trump's first term was defined by deregulation, reshoring, and pricing transparency. His Right to Try Act expanded access to experimental treatments, though it had limited practical impact on CGT because of the complex manufacturing realities. His administration pushed for faster regulatory pathways, leading to accelerated approvals for pioneering therapies like Zolgensma and Luxturna. Looking ahead, Trump’s second term will likely double down on domestic biomanufacturing incentives and promote industry-friendly policies at the FDA. However, his stance on drug pricing remains unpredictable – while deregulation and streamlined approvals may encourage investment, potential cost-cutting measures could introduce new constraints on pricing flexibility.   

Pashazadah: For the healthcare industry, the main impacts that immediately spring to my mind from Trump’s first presidential term were primarily COVID-19 related. Under Trump, the US government stepped in and provided the funding required for selected companies to produce, manufacture, and distribute COVID vaccines. The US government then paid for the vaccines at commercial rates, as opposed to using leverage to buy them at cost plus rates. 

In Trump’s second term, uninhibited by pandemics, I think there will be a very different focus with the government asking challenging, fundamental questions about the biopharma and healthcare sectors. Within days of Trump’s inauguration, the role of long-established institutions, such as the WHO, were questioned. As a result, I do not think the next four years will be boring. Fundamental questions will be asked that frontline medical staff, such as doctors, frequently think about but dare not ask. It is only by asking fundamental questions about the way we have done things in the past, understanding where the inefficiencies are, and how we can do things better, that the sector will advance. 

The reaction to the appointment of RFK Jr. has been largely an emotional one. There will be a period of uncertainty for investors as RFK Jr and his team settle. However, as the industry has seen four years of incredibly low financing already, the tough questions that the new administration is likely to take could signal a change. 

Baraniak: During his previous presidency, Trump focused heavily on deregulation, such as cutting red tape and reducing the role of government in sectors such as healthcare. However, his administration's policies were sometimes marked by sharp swings, and his reactions to challenges were unpredictable. For example, while he supported efforts to lower drug prices and addressed certain healthcare gaps, he also took unpredictable stances on issues such as the Affordable Care Act and healthcare reform.  

Vnook: Trump focused on deregulation, fast-tracking drug approvals, and reducing bureaucratic barriers for biotech innovation in his previous term. His administration’s Right to Try Act empowered patients to access experimental treatments more easily, and Operation Warp Speed accelerated vaccine development at an unprecedented pace. Looking ahead, he may introduce policies that favor industry-led innovation, tax incentives for pharmaceutical R&D, and a rollback of price control measures.   

Is it now a case of knowing what to expect from Trump and working around that, or does there remain an element of unpredictability? 
 

Baraniak: Trump’s modus operandi has often been to shock and awe, maintaining an element of surprise with his actions and decisions. As a result, we can continue to expect the unexpected from him, particularly in the realm of healthcare policy. 

The industry must remain agile and ready to collaborate as we navigate both the unpredictable nature of his leadership and the broader challenges posed by what many perceive as a war on science. Collaboration and resilience will be key as we face these potential disruptions head-on.  

Vnook: Trump’s pro-business stance and focus on reducing government intervention are relatively predictable. However, his leadership style and ability to enact swift policy shifts drive unpredictability. The industry can anticipate deregulation, tax breaks, and efforts to reshape global healthcare agreements, but the execution of these policies may not follow traditional legislative processes.  

Greenberg: Predicting Trump’s pharma policies is like forecasting a hurricane – it’s clear the winds are shifting, but the exact path remains uncertain. While his pro-business stance suggests deregulation and biomanufacturing incentives, potential shake-ups in drug pricing and regulatory oversight could create industry turbulence. The industry must prepare for rapid shifts in policy direction, necessitating agility in regulatory and commercial strategy.

Pashazadah: This is a period when the entire sector needs to embrace and manage change. We now see there are no sacred cows, and no institution is off-limits. It is impossible to predict in which sequence the cards will be turned over. In my view, by the end of this term, most – if not all the cards – will be turned over at least once.  

In an ideal world, what changes would you like to see from a government that could benefit pharma R&D? 
 

Vnook: An ideal government approach would balance patient access with industry sustainability to ensure fair drug pricing while maintaining incentives for biotech and pharma innovation. Policies should support faster approval pathways, encourage public-private partnerships for drug development, and provide tax incentives for high-risk, high-reward research. A regulatory framework that fosters both competition and investment in next-generation therapies would be a win-win for patients and the industry.  

Baraniak: Ideally, the government would prioritize policies that drive innovation and accessibility. Increased investment in life sciences would accelerate breakthroughs, while more flexible payment models could expand access to cutting-edge therapies. Regulatory frameworks should evolve to be more adaptive and permissive, ensuring safety remains paramount while reducing unnecessary barriers to rapid advancement. Additionally, greater education for both legislators and the public on the complexities of biotech and pharmaceutical development would foster more informed decision making and support for the sector. Of course, in light of the first few weeks of this administration, we must acknowledge the importance of continued federal funding for research innovation and workforce development to continue to maintain a competitive advantage globally and to bring cutting edge therapies to patients globally. 

Pashazadah: Without a doubt, one immediate change to policy that would have wide-ranging effects is to provide tax incentives for R&D that are returned to the industry. Currently, as a general rule across many countries, the tax breaks there can never be truly utilized to create liquidity for the industry.  

Greenberg: Particularly in CGT, I would look for stable, long-term CGT reimbursement models to ensure pricing sustainability. Global regulatory harmonization for faster multi-region clinical trials will also be crucial. I would also like to see US investment in CGT workforce training and talent development.