Insights

THE CURRENT ENVIRONMENT 

Life science organizations and other stakeholders impacted by the U.S. Food and Drug Administration (FDA) face exciting opportunities and demanding challenges, operating at the nexus of cutting-edge science, patient needs, and evolving regulatory requirements while facing political and regulatory scrutiny.  

Novel therapies, including those created through advancements in cell and gene therapies, and the prospects of personalized medicine have real potential to address unmet patient needs in curative and transformative ways. The life sciences sector also faces new and continuing economic pressures, from the length and cost of clinical trials to pressures to reduce product pricing. 

New technology-driven innovations, including artificial intelligence (AI), can enhance the drug discovery and development process, decreasing the time it takes for a new product to reach patients. In addition to supporting patients, transformations in digital systems can streamline manufacturing operations and improve data access and Along with the opportunities of digital technologies, challenges have arisen associated with digital and data security, interoperability, and data utilization.  

Other health care stakeholders, such as payers and providers, are also impacted by regulatory decision-making regarding accelerated approvals, labeling, and restrictions on product distribution and use.  

Stakeholders are also navigating a new and evolving federal policy landscape:  

• The FDA regulatory environment is evolving and uncertain, adding another layer of complexity for new technologies that do not fit cleanly into existing regulatory frameworks.  
• Increased focus from policymakers, politicians, and the public on product approval and safety add a new layer of federal policy threats and opportunities.  
• Domestic and geopolitical events and tensions have exposed vulnerabilities in the supply chain, from active pharmaceutical ingredient sourcing to cold-chain logistics to contract manufacturing networks.  

With the Prescription Drug User Fee Act (PDUFA) and other key user fees set to expire in 2027, the next year is poised to be a significant year in agency action and Congressional policy development.  

Now more than ever, with technology moving faster than regulation and changes in FDA leadership and policies, FDA-regulated companies and life sciences stakeholders may find it challenging to navigate the federal regulatory and policy landscape. The Leavitt Partners team will help you navigate the complex and ever-changing challenges of the current environment with confidence by helping you stay informed, adapt to regulatory shifts, and proactively and strategically engage in the areas most important to your business. 

OUR EXPERTISE 

We help life science clients understand how complex and evolving federal policies and regulatory decisions impact their products and customers. We guide organizations seeking to thrive in this dynamic atmosphere by providing the most current policy and regulatory information, informed by partners who understand the processes and the underlying policies under consideration. With our experience as Agency leaders, Congressional staff, administration officials, and private sector leaders, Leavitt Partners is uniquely positioned to develop and execute policy, regulatory, alliance, and advocacy strategies to help life sciences stakeholders mitigate regulatory and policy risk and leverage opportunities to advance your priorities.  

The Leavitt Partners team comprises experienced professionals with firsthand, in-depth knowledge of the regulatory and legislative issues facing life-sciences stakeholders. Our staff has: 

• Served in senior leadership roles at FDA within the Office of the Commissioner and FDA product centers, where they led programmatic, policy, and legislative initiatives; oversaw implementation of new laws, regulation of emerging technologies; and worked with diverse sets of stakeholders to inform FDA decision-making and respond to public health crises. 
• Served as lead FDA and Public Health Professional Staff on the Senate Health, Education, Labor, and Pensions (HELP) Committee and the House Energy and Commerce (E&C) Committee, leveraging deep policy expertise to draft and drive enactment of all significant FDA-related legislation during their service. 
• Served in leadership roles within the U.S. Department of Health and Human Services (HHS), advising the Secretary on legislative matters affecting the department, and developed and implemented initiatives related to opioids and the 21^st Century Cures Act. 
• Launched successful multi-sector Alliances to develop and advocate for policies related to a national system for drug supply chain traceability and security, advancing interoperable electronic food traceability, mRNA and next-generation encoding RNA therapeutics and vaccines, making the medicines development process more efficient and less resource intensive by utilizing medicine development tools, protecting research into treatments for rare diseases and rare cancers.  
• Practiced food and drug law at private law firms, counseling health care and life science clients on regulatory, compliance, and transactional matters. 

OUR SERVICES 

The Leavitt Partners teams’ broad experience allows us to look strategically across life sciences organization’s portfolios and business goals. Our team is uniquely positioned to understand how product-specific strategies and broader policy, advocacy, and stakeholder efforts fit together and move them forward together to best support our clients and their goals. 

• FDA Regulatory Strategy: Helping clients understand relevant FDA offices, personnel, and decisionmakers and developing and refining strategies for engaging at the appropriate level at the right time on product development and regulatory submissions, making sure that the right questions are asked and answered as efficiently as possible. 
• Policy Strategy and Development: Developing regulatory and legislative policies and strategies to successfully work with policymakers to align with organizational goals. 
• Stakeholder Engagement: Engaging external support for clients’ development and marketing strategies (e.g., external experts, patient and provider groups). 
• Agency and Legislative Intelligence: Providing real-time information and insights on agency actions, as well as Hill insights, including committees of jurisdiction and leadership activities, hearings, and analyses of proposed legislation. 
• Advocacy Strategy: Providing comprehensive advocacy planning and execution, which may include direct lobbying, to make sure messages cut through the noise in the agency and on Capitol Hill.  
• Alliance Building: Bringing together diverse stakeholders to build multi-sector alliances that are committed to consensus-based solutions to drive forward meaningful change. 

We work with organizations to provide actionable information, developing regulatory and policy solutions to your unique challenges and executing specific strategies to further policy and regulatory goals. From the most sophisticated multi-national organizations to the smallest start-ups, we help life sciences organizations navigate a turbulent and often confusing Washington, D.C. 

OUR WORK 

• Worked with a leading biomedical manufacturer association to develop industry-wide principles for increasing clinical trial diversity. 
• Established a stakeholder working table to advance targeted policies to solve problems related to the development of treatments for brain diseases, mental health conditions, and brain injuries, which led to   Congress appropriating $2 million for the Neurology Drug Program at the FDA.  
• Conducted a landscape assessment assessing supply chain opportunities and threats for a large pharmaceutical manufacturer. 
• Developed and drafted legislation for the expedited review of newly FDA- approved screening technologies by the United States Preventative Services Task Force (USPSTF). 
• Convened a multi-sector alliance to draft and secure enactment of the Drug Quality and Security Act. 
• Convened a group of diagnostic industry and clinical laboratory participants to develop and draft a proposed regulatory framework for the regulation of laboratory developed diagnostic tests. 
• Assessed a large pharmaceutical manufacturer’s products, research and development initiatives, product innovations, supply chain, workforce, and manufacturing capacity, commercial priorities, and unique value proposition for alignment with potential U.S. government interests. 
• Provided intelligence and insights related to implementation of the Inflation Reduction Act (IRA) and other regulatory policy priorities, including interests, priorities, and initiatives of Congress, FDA, HHS, and stakeholders. 
• Assessed and supported opportunities for federal R&D support and procurement of medical products, including medical countermeasures. 
• Helped a major national patient advocacy organization prioritize their policy goals and develop a roadmap to support their implementation.  
• Engaged with a manufacturer to provide strategy and support on key regulatory issues for successful submission and approval of a BLA. 
• Advised health care investors of the risks and opportunities facing a specific sector or investment opportunity stemming from a federal action or policy development. 

OUR CLIENTS 

• FDA-Regulated Industry: Biotechnology, pharmaceutical, vaccines and biologics, medical devices, food and dietary supplements, and the associations that support them. 
• Public Health: Patients and patient advocates, consumers, academia, health care professionals, pharmacies and pharmacy associations, coalitions and associations, and researchers. 
• External Stakeholders: Third-party logistics providers, technology and service providers, wholesalers, distributors, and contract manufacturers. 
• Other Health Care Stakeholders: Health care systems, foundations, trade associations, large employers, health plans, and other health care stakeholders that rely on access to FDA-approved products.