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Policy Briefing: Executive Order 14091

Executive Order 14091: Pivotal Opportunity for Healthcare Manufacturers

Understanding the Impact and Strategies for Manufacturers to Address SDoH

On February 16, 2023, President Biden signed Executive Order 14091, titled ‘Advancing Health Equity and Racial Justice by Addressing the Social Determinants of Health.’ This Order has immediate and significant implications for the country, particularly for historically underserved communities and populations. It directs federal agencies to prioritize funding for research that addresses social determinants of health (SDoH) and establishes equity teams within several departments. Additionally, it creates a White House Steering Committee with substantial authority to monitor and oversee the implementation and address obstacles or lack of progress. This committee of representatives from several federal agencies will be responsible for developing strategies and recommendations for addressing SDoH, including recommending changes to regulations or policies that impact access to healthcare services and products and providing guidance on best practices for addressing SDoH in clinical settings.


Prioritizing funding for research

One of the key impacts of Executive Order 14091 on the healthcare industry is its emphasis on prioritizing funding for studies that address SDoH. This incentivizes manufacturers to focus their research on developing drugs and devices that address upstream barriers and root causes of health disparities. By creating incentives for developing new treatments and therapies that produce equitable health outcomes across all communities, this Executive Order has the potential to benefit biotech and pharmaceutical companies, as well as startup digital health companies that are focused on making a positive impact on population health.
The Executive Order includes a focus on grant funding. It encourages researchers and organizations to prioritize SDoH in their work to increase the chances of receiving funding for projects and studies that seek to address these issues. For healthcare manufacturers, this shift in focus could create more opportunities for collaborations with research institutions and even non-government community organizations to develop solutions to address SDoH while providing opportunities for federal grants.


A pivotal opportunity for healthcare manufacturers

Biotech and Pharmaceutical manufacturers have a pivotal opportunity to develop partnerships to leverage the research and the resulting policies to better understand the barriers to care and develop products and solutions that address the root causes of health disparities. To create tailored strategies that ensure pricing and access goals are achieved, manufacturers must have extensive expertise in commercialization, market access, and patient support services. It will be essential to identify and generate SDoH evidence, not only for federal funding requirements, but these are increasingly important in coverage decisions.
This Executive Order has the potential to shift market dynamics, the insights revealed through this research will inform policy and coverage changes. Competitors will adjust their strategy to overcome the barriers that keep patients from starting and staying on therapy. It will be essential to have a view across the clinical development and commercial landscape to adapt strategies accordingly.
The timeline for Executive Order 14091’s implementation is still being determined. Here at Herspiegel, we are keeping a careful eye on how the Executive Order is being implemented to ensure our clients can are ready to create evidence-generation plans, design patient support programs, tailor market access strategies, and adapt to the market changes that are sure to come as all healthcare stakeholders place more emphasis on the SDoH.

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Herspiegel is a leading professional services firm helping biotech start-ups and the world’s largest pharmaceutical companies navigate the path from science to brand performance and change patients’ lives. We are committed to using strategic insights from medical to commercial to market access to solve critical problems.