Practice Focus

Mahnu Davar is a member of the firm's FDA and healthcare practice group and counsels clients on issues related to advertising and promotion of US Food and Drug Administration- (FDA-) regulated products, regulatory enforcement and investigations, and compliance, ethics, and corporate governance.

In April 2010, Mr. Davar completed a nearly year-long secondment at a major US-based specialty pharmaceuticals company. In his capacity as a "secondee", Mr. Davar served as the lead "in-house" commercial business lawyer supporting four key pain product franchises, including two "black box" products. In this role, Mr. Davar advised his business clients on a variety of critical regulatory, contractual, and compliance issues related to advertising and promotion, research and development, alliance management, and new product acquisitions.

Prior to joining Arnold & Porter LLP, Mr. worked as a law clerk at Wyeth Pharmaceuticals in Collegeville, Pennsylvania in 2005 and taught Legal Writing at the University of Pennsylvania Law School as a student instructor in 2006-2007.  Mr. Davar's graduate work at the University of Pennsylvania Center for Bioethics focused on vaccine law and policy, international clinical trial design, and healthcare dispute mediation.  Mr. Davar has written and contributed to articles and presentations on a broad range of topics related to the pharmaceutical and device industries, including marketing practices, government enforcement, clinical research ethics, corporate governance, and bribery and kickback regulation.

Mr. Davar lived and travelled in India as a Fulbright Scholar from 2003-2004. Outside of his legal practice, Mr. Davar is a mixed-media artist and graphics designer.

Representative Matters

• Representing several pharmaceutical manufacturers during government investigations into advertising, promotion, and reimbursement assistance practices
  • Assisting with and conducted internal investigations, including interviews of sales, marketing, medical, and executive functions
  • Working with forensic accountants to design damages models
  • Developing civil and criminal defense strategies for corporations and individuals
  • Helping manage document retention and production issues
• Designing and implementing global Foreign Corrupt Practices Act (FCPA) compliance and training program for major multinational cosmetics company
  • Conducting on-site trainings for global legal, compliance, finance, and other functions
  • Helping assess key risk areas related to global business practices in Asia, Latin America, and Central and Eastern Europe
• Counseling several pharmaceutical manufacturers on development of international clinical study programs, including studies in rare conditions and/or highly vulnerable patient populations
  • Reviewing study protocols, informed consent documents, and contract research organization agreements
  • Helping structure payments to investigators to conform with federal healthcare and anti-bribery laws
  • Counseling clinical and research and development personnel on best practices for study termination
  • Advising client on development of clinical press releases and scientific communications related to study findings
  • Developing FDA and US Department of Health and Human Services Office for Human Research Protections (HHS/OHRP) communication strategies
• Assisting several major pharmaceutical and device manufacturers to review marketing strategies and tactics, including sales force compensation, promotional materials, and reimbursement support activities on an ongoing basis
• Helping several major pharmaceutical and biologics manufacturers to develop educational and charitable giving policies to comply with state and federal healthcare laws and the FCPA
• Negotiating numerous clinical trial site agreements, investigator-initiated study agreements, promotional speaker agreements, and vendor agreements on behalf of a pharmaceutical manufacturer
• Conducting comprehensive audit of pharmaceutical manufacturer’s compliance program as part of subsidiary-parent integration effort
• Assessing pharmaceutical manufacturer’s policies and procedures governing its promotional materials review process
• Developing policies and procedures governing manufacturer’s use of medical science liaisons, off-label information, reimbursement assistance, and other topics
• Assisting several pharmaceutical manufacturers to assess compliance and governance requirements under existing Corporate Integrity Agreements
• Conducting regulatory due diligence on several potential target pharmaceutical and device companies for existing client pharmaceutical manufacturer
• Helping pharmaceutical manufacturer to investigate, report, and resolve drug diversion issue
• Counseling pharmaceutical manufacturer on response to FDA Untitled Letter and design and implementation of corrective action 
• Counseling start-up biologics company on regulatory approval strategy for complex combination product
• Advising representatives of the Ministry of Health of an African republic on human research subject protection issues and to draft a clinical research policy
• Successfully defending independent medical necessity claims review provider against civil claims inPennsylvania State Court (UPMC Health Plan v. Permedion, No. 1839 C.D. 2008 (Pa. Commw. 2009))