Partner
Foley & Lardner, LLP
Chicago, Illinois
Monica R. Chmielewski is a health care and life sciences lawyer with over 20 years of experience solely focused on the representation of health care providers, pharmaceutical and medical device companies, and pharmacies in health care, health care transactions, clinical research, supply chain, and food and drug law. She is a partner at Foley & Lardner, LLP and co-chair of the firm’s Life Sciences Industry Team, as well as vice chair of the firm's Health Care Industry Team. Monica provides daily counsel to numerous health systems, hospitals, academic medical centers, pharmacies and biotech, pharmaceutical and medical device companies. As such, she regularly assists clients with issues including, but not limited to:
• Regulatory compliance governing all aspects of clinical research
• Research grants and funding
• Government investigations and audits
• Pharmaceutical product promotion
• Pharmacy Benefit Managers (PBM) matters
• Customs import and export issues
• Pharmacy and supply chain matters (including group purchasing organizations)
• Corporate practice of medicine and dentistry prohibitions
She counsels health plans in their procurement of and contracting with PBMs for mail, retail, and specialty drug services in connection with commercial and government health care programs. She provides counsel regarding PBM audits, as well as on regulatory issues for various retail and specialty pharmacies, including state Boards of Pharmacy inspection and adverse findings, compounding pharmacy matters, and licensure.
Monica counsels pharmaceutical and medical device companies, pharmacies and laboratories regarding the operation and functions of their corporate compliance and integrity programs.
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