Mark Ogunsusi is a partner in the firm's Healthcare and FDA practice group. With over 15 years of combined experience as a pharmacist and healthcare lawyer, Mark advises clients on complex state and federal regulatory, transactional, and compliance issues across the pharmaceutical and healthcare delivery sectors. His practice spans pharmaceutical pricing, pharmacy operations, FDA and DEA compliance, pharmacy reimbursement, and legislative drafting and advocacy.
Mark represents health systems, integrated delivery networks, federally qualified health centers, Ryan White clinics, retail chain pharmacies, specialty pharmacies, grocery pharmacies, group purchasing organizations, state provider associations, state pharmacist associations, and technology vendors, among others. He is widely recognized for his deep experience with the 340B drug pricing program, including patient eligibility, virtual inventory accounting systems, contract pharmacy arrangements, HRSA audits, manufacturer disputes, and Medicaid carve-in/out strategies. He also advises health system and pharmacy clients on state and federal regulations governing PBM auditing, reimbursement, and disputes. He assists clients with navigating limited distribution models, specialty pharmacy contracting, innovative centralized and specialty pharmacy infrastructure, and cell and gene therapy arrangements.
Mark’s practice includes advising traditional compounding pharmacies on compliance with Sections 503A of the Federal Food, Drug, and Cosmetic Act. He counsels clients on facility design, SOPs, BUDs, labeling, inspection readiness, and adverse inspection responses, including Form 483s and Warning Letters. He also represents clients before the FDA in connection with audits and compliance investigations.
Mark has played a pivotal role in drafting and advising on state and federal legislation and regulations affecting pharmacy reimbursement, drug distribution, licensure, and PBM oversight. He routinely partners with health systems, advocacy groups, and policymakers to shape drug pricing frameworks that promote access and equity. He has experience relating to research pharmacy operations and sponsor audits.
Prior to joining the firm, Mark was a senior associate at a Washington, D.C.-based health law firm. He also led a healthcare and technology consulting firm and previously served as a health law fellow with an international law firm. Mark began his career in healthcare as a pharmacist, with clinical experience in safety-net hospitals, independent pharmacies, and underserved rural communities.
At K&L Gates, Mark continues to advise institutional and community-based providers on emerging pharmacy delivery models, value-based care strategies, and risk mitigation initiatives. His work is guided by a commitment to public health infrastructure, equitable access to pharmaceutical services, and the future of pharmacy-led care.
