Simone Colgan Dunlap

Strategic counsel for healthcare companies navigating regulatory hurdles and business challenges 

Simone Colgan Dunlap focuses her practice through the lens of the pharmaceutical, medical device and biologics supply chain. She advises on health care regulatory compliance, related risk management and contracting matters for a variety of clients, including drug and device manufacturers, pharmacy benefits managers (PBM), third-party administrators (TPA), healthcare insurers, discount medical plan organizations (including prescription discount card administrators), pharmacies, specialty pharmacies and vendors serving:

• Healthcare regulatory compliance
• Healthcare privacy and artificial intelligence (AI)
• Structuring and drafting agreements for innovative healthcare arrangements, technologies and services

Simone understands the business of healthcare and partners with clients to find practical and creative solutions.

One client noted on her Chambers 2026 profile that "Simone's deep expertise in our space has been invaluable to our business. She has provided expert advice in developing and defending legal positions on complex issues." Another client praised her ability to handle complicated matters, noting, “Her ability to analyze complex legal issues and develop effective solutions is impressive, and her professionalism makes every interaction both productive and enjoyable.”

• Drafting and negotiating agreements, including distribution agreements for drugs and devices, business associate agreements, group purchasing organization agreements, rebate services agreements, data use agreements, licensing agreements, pharmacy services agreements, specialty pharmacy services agreements, prior authorization (PA) support services, data use agreements, HUB agreements, marketing agreements, Risk Evaluation and Mitigation Strategies (REMS) consulting agreements, provider network agreements, independent contractor agreements and numerous other commercial contracts.
• Advising healthcare stakeholders on compliance with federal and state fraud and abuse laws, including the Anti-Kickback Statute and Civil Monetary Penalties Law.
• Providing strategic advice to clients on healthcare business models and regulatory issues, including interoperability, government investigations and enforcement actions, permitting and licensure, controlled substances, prescription dispensing, in-office dispensing, FDA compliance, review of promotional materials for drug products, medication therapy management (MTM) programs, direct-to-consumer distribution models, direct-to-employer distribution models, manufacturer market access models, telemedicine, telepharmacy, compounding and records retention.
• Advising healthcare stakeholders on privacy and AI laws, including HIPAA/HITECH, as well as state laws governing the confidentiality of health information, medical records, mental health records and records containing other sensitive information.
• Coordinating and deploying attorney teams to provide short- and long-term customized contracting and legal support during peak work periods, emergencies and for special projects.