Mahnu V. Davar | People | Arnold & Porter

Mahnu Davar co-chairs the Life Sciences & Healthcare Regulatory practice and is a trusted partner to lawyers, compliance officers, regulatory professionals, and business executives across the life sciences industry. Mahnu counsels clients on mission-critical FDA, CLIA, fraud and abuse, and state licensing regulatory matters, including compliance program development and management. He routinely assists multinational companies with sensitive internal investigations, regulatory inspections, product quality and safety issues, data integrity concerns, and government enforcement matters. He frequently assists medical technology and diagnostics clients with product classification, clearance/approval, and commercial strategy issues.

Mahnu’s clients include biotechnology startups, non-profit research institutions, major clinical laboratories, and some of the world's largest pharmaceutical and medical technology companies in the oncology, ophthalmology, and pain care spaces. His practical, interdisciplinary approach to counseling is informed by prior secondments in the legal departments of major life sciences companies where he has acted as the lead commercial lawyer for several blockbuster biopharma and surgical product franchises. Mahnu is an Adjunct Professor at Penn Law School, a Fellow of the Salzburg Seminar, and a former Fulbright Scholar to India.

Focus Areas

Experience

Lead FDA and compliance counsel to several rare disease companies, including in the gene therapy and immune medicine space, in connection with commercial launch readiness activities.
Lead outside regulatory counsel to major reference laboratory.
Lead FDA strategy counsel to several clinical decision support and clinical diagnostics technology developers, including innovative technology functions sitting within multinational pharma companies.
Lead FDA counsel on several first-in-class, innovative home access diagnostic and wellness testing products, including one of the first at-home-based COVID-19 diagnostics.
Lead FDA and compliance counsel to several consumer products companies, including automotive manufacturer and applied materials company, to assess implications of in-licensing or home-grown development of medical products, including in connection with COVID-19 related countermeasures.

Lead FDA diligence counsel to labcorp in connection with several strategic health tech acquisitions.
Leading proactive compliance effectiveness assessment projects for several biotechnology companies.
Lead regulatory counsel to major ophthalmology device and drug product distributor in connection with state and federal licensing and registration issues.
Lead R&D regulatory and compliance counsel for numerous biotechnology and pharmaceutical companies.
Counseling several pharmaceutical companies about disclosure requirements under Corporate Integrity Agreements, including in the context of issues found through asset and corporate acquisitions.
Lead FDA and compliance counsel to numerous biotechnology and medical device companies in connection with clinical and real-world evidence research study programs.
Led comprehensive internal review of fair market valuation approach to clinical research, investigator-initiated study support, and supply agreement contracting for multinational pharmaceutical company.
Led several post-integration regulatory and compliance assessments as counsel for buyer or owner company.
Led internal review and enhancement of clinical trial data integrity and GCP compliance procedures.
Led multinational anticorruption compliance training program for hundreds of employees across Sales, Finance, Legal, and Compliance functions in Europe, Asia, and the Americas.
Developed regulatory compliance playbook for collaboration and engagement strategy for first-in-class cellular therapy product launch.
Represented dozens of individuals and entities in routine and for-cause state and federal regulatory inspections and surveys, including CMS-CLIA, NY-CLEP, FDA-BIMO, FDA-QSIT, and state boards of pharmacy.

Representing global pharmaceutical company in connection with state and federal investigations into board of pharmacy and diversion control violations.
Representing major ophthalmology products distributor in connection with parallel state board of pharmacy investigations involving allegations of unlicensed or lapsed wholesale distributor license distribution. Successful resolutions reached in several states without admission of violation or revocation of licensure.
Advising several biotechnology companies in connection with DOJ investigations into Medicare billing practices at clinical trial sites.
Representing surgical device start-up company executive in connection with allegations of regulatory and research misconduct violations in the US, Argentina, and Brazil.
Representing major biopharmaceutical company in an FDA and DOJ investigation into alleged clinical research fraud at a trial site.

Represented diagnostics technology manufacturer in an ongoing FDA and DOJ investigation into alleged product accuracy and quality issues. Government declined to pursue enforcement.
Led internal investigation into potential HCP payment transparency reporting violations at specialty pharmaceutical company.
Led internal investigation for global biotechnology company into alleged travel reimbursement/meal violations and sham speaker programs in Japan.
Led internal investigation for global pharmaceutical company into alleged employee-vendor conflicts of interest and commercial bribery at the Asian manufacturing and technical operations unit.
Represented surgical product company quality executive in connection with federal criminal investigation related to off-label marketing and “hidden recall” allegations; DOJ declined to prosecute.
Led internal investigation into potential cGMP violations at specialty pharmaceutical company.
Represented major pharmaceutical company in connection with parallel federal investigations into marketing, patient assistance, and product pricing practices. Civil settlement reached with no criminal charges filed.
Led several internal investigations related to research misconduct, GCP breaches, and data integrity issues in sponsored studies at major medical research institution, including FDA self-disclosure-driven review. FDA declined to pursue debarment or sanction.
Represented major pharmaceutical company in connection with federal civil investigation into product manufacturing and marketing practices.
Represented major multinational pharmaceutical and medical device company in connection with parallel civil investigations into product sales and marketing practices, product support services, and lease/discount arrangements. Government declined to pursue enforcement.
Represented major biopharmaceutical company in connection with federal criminal investigation into marketing and publication practices. DOJ declined to pursue enforcement.
Represented major pharmaceutical company in State Attorney General investigation into marketing practices from subpoena response phase through settlement.
Represented major biopharmaceutical company in connection with federal criminal investigation into research and data integrity issues from subpoena response phase through declination.
Represented major pharmaceutical companies in connection with Congressional investigations into marketing practices and relationships with patient foundations.
Represented major pharmaceutical company in parallel federal civil and criminal investigations from subpoena response phase through negotiation and settlement of both investigations.

Representing 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.
Successfully represented US Army Veteran in a discharge upgrade appeal before the US Army Board for Correction of Military Records.
Advised representatives of the Ministry of Health of an African republic on human research subject protection issues and helped to draft a national clinical research policy.
Successfully represented indigent cancer patient in hospital billing dispute with major DC medical center.
Assisted board of area visual arts non-profit with development of strategic plan and vision statement.