- MA (bioethics)University of Pennsylvania7
- JDPenn Law7
- BAJohns Hopkins3
Mahnu Davar is a Partner at Arnold & Porter LLP in Washington, DC in the firm’s Lifesciences and Healthcare Regulatory practice. Mr. Davar’s practice focuses on counseling pharmaceutical, biologics, and medical device (“medical products”) companies on issues related to FDA/healthcare law compliance, government investigations, and clinical research ethics.
Mr. Davar has played a lead role in helping clients resolve state and federal enforcement actions involving allegations of off-label marketing, misuse of clinical research and publications, Good Manufacturing Practices deviations, and domestic and foreign bribery/kickbacks. He has helped numerous multinational medical products companies conduct internal investigations, review high-risk business activities and transactions, and engage in compliance enhancement and remediation exercises, including in Europe and Asia. He has also worked with a major academic medical research center to investigate and resolve allegations of scientific fraud and clinical trial misconduct.
At the request of clients, Mr. Davar has been seconded to act as an in-house brand lawyer at several major medical products companies, bringing a practical perspective to his practice. As a secondee, Mr. Davar has been responsible for a host of critical legal and compliance issues including: product advertising and promotion; payments to healthcare professionals and consultants; clinical research and development; vendor contract negotiation and management; submissions and reporting to regulatory authorities; audits and inspections; lifecycle management and strategic planning; alliance management; and deal due diligence.
Mr. Davar has advised representatives of the Ministry of Health of an African republic, pro bono, on human research subject protection issues and helped to draft a national clinical research policy. He also represents, pro bono, Children’s Hospice International - a non-profit advocacy organization focused on developing a better paradigm of care for children with life threatening illness - on a host of legal and legislative strategy issues. Mr. Davar’s recent writing and speaking activities have focused on FDA regulation of internet and social media activities, bribery risks in overseas clinical trials, and trends in False Claims Act enforcement.
Mr. Davar is a 2007 graduate of the University of Pennsylvania Law School and has a Masters in Bioethics from the University of Pennsylvania Medical School. While at Penn Law, Mr. Davar taught as a 3L Legal Writing Instructor and was part of a semi-finalist team in the 2006 Wharton Business Plan Competition. He graduated with honors, Phi Beta Kappa, from Johns Hopkins University. Mr. Davar lived and traveled in India as a Fulbright Scholar from 2003-2004 and is a Fellow of the Salzburg Global Seminar.