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.
