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Remarks Delivered at Public Meeting on FDA's Rare Disease Innovation Hub

October 16, 2024 Attorney Mary Kohler was invited to comment during a public meeting on FDA's plan to launch a Rare Disease Innovation...

Vertex Suit Highlights Issues for Pharma Fertility Support

September 19, 2024 | By Mary Kohler in Law360 On July 15, Vertex Pharmaceuticals Inc. sued the U.S. Department of Health and Human...

Unpacking HHS' Opinion on Cell Therapy Refund Programs

July 30, 2024 | By Mary Kohler in Law360 Cell and gene therapies grab headlines for the miracles they deliver and for their seven-digit...

Assessing HHS' Stance On Rare Disease Patient Assistance

May 13, 2024 | By Mary Kohler in Law360 It's a rainy rush hour. You're trying to navigate trucks on the freeway when your teenager...

DOJ's Biopharma Settlement Raises Anti-Kickback Questions

January 23, 2024 | By Mary Kohler in Law360 You've lost your wedding ring on the beach. Do you frantically comb the sand, or find a...

Reading Between the Lines of HHS OIG's National Lab Opinion

November 3, 2023 | By Mary Kohler in Law360 The U.S. Department of Health and Human Services' Office of Inspector General recently...

HHS Neuromonitoring Advisory May Have Broad Relevance

September 7, 2023 | By Mary Kohler in Law360 You start a wildly profitable business. Competitors flock. Some take a more aggressive...

A Glimpse Into HHS' Digital App Enforcement Priorities

July 25, 2023 | By Mary Kohler in Law360 You need to see a cardiologist. Your primary care doctor recommends two. But one's not...

Celebrating 2 Years, and What I've Learned From Mom

July 6, 2023 July 4 brought Fun & Fireworks on the firm’s deck to celebrate 2 big birthdays 🎂 . Kohler Health Law finished its second...

Schutte Ruling Shifts Risk Calculus For Compliance Officers

June 22, 2023 | By Mary Kohler in Bloomberg Law Attorney Mary Kohler explores practical considerations for business leaders,...

DOJ Incentives Pilot Takes Carrot-Stick Approach to Compliance

May 8, 2023 | By Mary Kohler in Bloomberg Law Attorney Mary Kohler analyzes the DOJ’s financial incentives and clawbacks pilot, and...

Guidance on Patient Assistance Programs Needs Careful Review

April 5, 2023 | By Mary Kohler in Bloomberg Law Health-care attorney Mary Kohler explains the intricacies of federal law and...

OIG Lays Out Risks for Continuing Education Funding

July 14, 2022 | By Mary Kohler The US Department of Health and Human Services, Office of Inspector General (OIG) recently posted...

Kohler Health Law has officially launched

May 18, 2022 I’m delighted to announce the official launch of Kohler Health Law. After a quiet start in late 2021, the firm’s website is...

Health Cos. Could See More Conference Enforcement Risk

April 20, 2022 | By Mary Kohler in Law360 Medical conferences fuel the development of new therapies. Research professionals share...

Social Media Endorsements Can’t Escape FTC’s Watch

Nov. 9, 2021 | By Mary Kohler in Bloomberg Law The FTC recently sent 700 retailers and advertisers a letter alerting them to...