FDA and Healthcare

Mahnu Davar is a member of Arnold & Porter LLP's FDA and healthcare practice group and primarily counsels pharmaceutical, biologics, and medical device (“medical products”) companies on issues related to state and federal healthcare law compliance and government investigations.  Mr. Davar also works with clients on issues related to clinical ethics and corporate governance.

Mr. Davar has played a lead role in several major government investigations involving allegations of off-label marketing, misuse of clinical research and publications, and domestic and foreign bribery/kickbacks.  Outside of the enforcement context, Mr. Davar has helped numerous multi-national medical products companies conduct internal investigations, review high-risk business activities and transactions, and engage in compliance enhancement and remediation exercises.  Notably, Mr. Davar has developed and led in-country compliance training programs in Europe and Asia. 

Mr. Davar’s experience as a secondee at both pharmaceutical and medical device companies gives him a practical perspective when counseling clients on challenging legal and compliance issues.  At the request of clients, Mr. Davar has served as the acting “line lawyer” for numerous branded prescription drug, medical device, and dietary supplement products.  As such, 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; submissions and reporting to regulatory authorities; audits and inspections; lifecycle management and strategic planning; alliance management; and deal due diligence.

Prior to joining Arnold & Porter, Mr. Davar worked as a law clerk at Wyeth Pharmaceuticals in Collegeville, Pennsylvania, and was involved, through the Wharton Business School, in helping to commercialize several novel medical device-related technologies.

Mr. Davar is a graduate of the University of Pennsylvania Law School and has a Masters in Bioethics from the University of Pennsylvania Medical School.  He graduated with honors from Johns Hopkins University where he was elected to Phi Beta Kappa.  Mr. Davar lived and travelled in India as a Fulbright Scholar from 2003-2004.

FDA and Healthcare Representative Matters

• Currently represents several pharmaceutical companies in the defense of off-label and anti-kickback enforcement actions.
• Currently conducting comprehensive review of R&D and Medical Affairs governance structures and divisional relationships at two multinational medical products companies.
• Currently advises several multinational medical products companies on the development of policies and procedures governing reimbursement and patient access support services, off-label and pharmacoeconomic information, payer interactions, grants and charitable donations, social media and consumer outreach programs, and clinical trial conduct.
• Currently counsels start-up and small scale medical device companies on advertising and promotion compliance issues.
• Currently reviews strategic marketing, employee compensation, and sales force/customer targeting plans for several multinational pharmaceutical and medical device companies to ensure compliance with federal healthcare laws.
• Currently counsels pharmaceutical and medical device manufacturers on compliance with Corporate Integrity Agreement requirements.
• Recently counseled specialty biologics company on proposed marketing campaign in connection with a new product launch.
• Recently counseled major multinational cosmetics company on development and implementation of comprehensive anti-bribery compliance program and third-party due diligence program for high-corruption risk markets in Asia Pacific, Latin America, and Eastern Europe.
• Negotiated numerous agreements between pharmaceutical company client and clinical and marketing consultants, marketing vendors, clinical researchers, and contract research organizations.
• Counseled specialty pharmaceutical company on regulatory and compliance issues involving a multi-center, international clinical trial involving a specialty drug for vulnerable patient populations with a rare medical condition.
• Represented a major pharmaceutical company during highly publicized congressional investigation into marketing, publication, and consulting practices.
• Successfully argued for dismissal of novel civil claims brought against state quality assurance contractor under Pennsylvania Department of Health regulations (UPMC Health Plan v. Permedion, Civ. No. 1839 C.D. 2008 (Pa. Commw. 2009)).
• 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.
• Successfully represented, pro bono, an indigent individual in out-of-court hospital claim negotiations.

• Currently represents several pharmaceutical companies in the defense of off-label and anti-kickback enforcement actions.
• Currently conducting comprehensive review of R&D and Medical Affairs governance structures and divisional relationships at two multinational medical products companies.
• Currently advises several multinational medical products companies on the development of policies and procedures governing reimbursement and patient access support services, off-label and pharmacoeconomic information, payer interactions, grants and charitable donations, social media and consumer outreach programs, and clinical trial conduct.
• Currently counsels start-up and small scale medical device companies on advertising and promotion compliance issues.
• Currently reviews strategic marketing, employee compensation, and sales force/customer targeting plans for several multinational pharmaceutical and medical device companies to ensure compliance with federal healthcare laws.
• Currently counsels pharmaceutical and medical device manufacturers on compliance with Corporate Integrity Agreement requirements.
• Recently counseled specialty biologics company on proposed marketing campaign in connection with a new product launch.
• Recently counseled major multinational cosmetics company on development and implementation of comprehensive anti-bribery compliance program and third-party due diligence program for high-corruption risk markets in Asia Pacific, Latin America, and Eastern Europe.
• Negotiated numerous agreements between pharmaceutical company client and clinical and marketing consultants, marketing vendors, clinical researchers, and contract research organizations.
• Counseled specialty pharmaceutical company on regulatory and compliance issues involving a multi-center, international clinical trial involving a specialty drug for vulnerable patient populations with a rare medical condition.
• Represented a major pharmaceutical company during highly publicized congressional investigation into marketing, publication, and consulting practices.
• Successfully argued for dismissal of novel civil claims brought against state quality assurance contractor under Pennsylvania Department of Health regulations (UPMC Health Plan v. Permedion, Civ. No. 1839 C.D. 2008 (Pa. Commw. 2009)).
• 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.
• Successfully represented, pro bono, an indigent individual in out-of-court hospital claim negotiations.

Washington, DC Super Lawyers "Rising Star" 2013 for FDA Law

Semi-Finalist Team Member (Gen X Genetics), Wharton Business Plan Competition (2006)