Kohler Health Law, PC

Mary Kohler of Kohler Health Law is a highly experienced adviser to emerging and mid-sized life science companies, drawing on more than two decades in-house at global biopharma leaders to provide strategic and operational support across regulatory, compliance, and product-related legal matters.

Kohler Health Law is a boutique, national practice that helps life sciences companies develop, launch, and commercialize FDA-regulated products.

Founder Mary Kohler brings 24 years of in-house experience at GlaxoSmithKline and Amgen to support smaller companies that need:

• A fractional or interim general counsel or compliance officer
• A sounding board for a GC or CCO who’s new to the role or building new capabilities
• An experienced adviser to support a growing legal or compliance team
• Sophisticated, practical advice to navigate complex health law and regulatory issues
• An extra pair of hands to get things done

Having stood in her clients’ shoes, Mary knows how to balance legal and regulatory constraints with business realities and internal dynamics. She can set strategy, benchmark, lead cross-functional teams, and craft practical solutions to complex problems. Her mission is to help clients manage risk through thoughtful decisions that teams can realistically implement.

Mary’s deep expertise as a product attorney includes oncology and rare diseases. At Amgen, she launched and led the healthcare compliance programme and served as a strategic adviser to the CCO. As a member of the CCO’s senior leadership team, she helped grow the programme, counsel clients through government investigations, navigate two corporate integrity agreements, and establish a formal risk assessment process to prioritise compliance resources.

Larger law firms often turn to Kohler Health Law when a client needs health law support—but the firm has a conflict or the matter calls for a more cost-effective solution.

Having worked in Big Law and Big Six Consulting, Mary understands the pace, expectations, and standards of those environments. She focuses on delivering high-quality results and clear value.

Mary advises on a range of regulatory and compliance issues, with particular focus on:

• Federal fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, Beneficiary Inducements CMP Law)
• FDA law and regulation related to clinical development and marketing
• Medicare Part B reimbursement of drugs and injectables
• Issue spotting for related laws, such as privacy, unfair competition (FTC), and others

When a client’s needs exceed her bandwidth or subject matter focus, Mary helps find—and vet—the right legal or compliance professionals for the job.

Mary provides the kind of practical, business-savvy legal support that internal teams need. Services include:

• On-call guidance for GCs and CCOs who need a quick gut check
• Fractional GC or CCO services, or a “pinch hitter” to cover gaps while teams build capacity
• Clear, straightforward policies and guidance staff can actually use
• Education and training across all levels—from staff to the boardroom—on key risks and compliance approach
• Advice on compliance programme operations: risk assessment, audits, investigations, monitoring
• Operational guidance on external funding, patient interactions, and the interface between commercial and medical affairs
• Structural advice on patient programmes (e.g., PAP, copay assistance, quick start, nurse educators, diagnostic/genetic testing)
• Anti-Kickback analysis of vendor relationships, including HUBs, CROs, and specialty pharmacies

Representative projects include:

• Conducted a board-level compliance programme review for a clinical-stage biotech
• Helped a large device company integrate U.S. healthcare compliance following an acquisition
• Advised a C-suite team on calibrating the medical affairs-commercial relationship
• Helped a company build a suite of compliant patient support programmes
• Designed a risk mitigation plan for a free diagnostic programme following recent DOJ and OIG scrutiny
• Refined a company’s document retention policy to reduce storage costs while maintaining regulatory readiness

Mary serves as Vice Chair of the Life Sciences Practice Group of the American Health Law Association, advancing education on legal and regulatory developments in the industry.

She is a regular speaker at industry conferences and was invited to provide public comment at the FDA’s Rare Disease Innovation Hub launch. She also teaches a life sciences compliance seminar at UCLA’s Graduate School of Public Health.

Her writing has appeared in Law360, Bloomberg Law, and other legal and industry publications. A selection of articles is available under the “Insights” tab on her website, www.kohlerhealthlaw.com.

555 Marin Street

Suite 200

Thousand Oaks, CA 91360

805.852.7709

www.kohlerhealthlaw.com

[email protected]