Julie K. Letwat Counsel

With a career spanning more than 20 years, Julie’s background is comprised of working in-house for pharmaceutical companies and professional medical associations, and at a global law firm in senior leadership roles.

Prior to joining McGuireWoods, Julie was counsel in the health law / FDA group at an international law firm where she oversaw legal matters for pharmacies and pharmacy benefits management services, pharmaceutical and biotechnology companies, wholesale distributors and manufacturers, physician practices and hospital systems. Julie’s areas of specialty include:

  • State and federal health care regulations, including FDA enforcement
  • Compliance program development and implementation
  • Strategic transactional matters, included mergers and acquisitions
  • Drug marketing and labeling
  • Government investigations and legislative advocacy
  • Market access and analysis, payment reform and reimbursement
  • Due diligence and business strategy
  • State boards of pharmacy and licensure

Drawn to the health care sector because of her skill at identifying and implementing legal and business concepts, Julie believes that health law is a legal field which is constantly growing and evolving. Her practical, results-oriented approach is why clients are drawn to her expertise in being able to delve into their legal issues, devise a strategy and execute efficiently.

I strive above all to avoid risk and to identify and correct potential problems before they emerge. When a crisis does arise, I take a calm, measured and practical approach developed over years of daily crisis management. I understand that health care companies must adapt constantly to a changing environment, and can provide guidance to find the right path forward, whether the change is necessary to better serve patients or to comply with regulatory standards.

Experience

Served as in-house legal counsel for a global company with a focus on government, regulatory, and compliance issues. Provided oversight of all domestic and international legal matters for five portfolio companies including FDA, health care, pharmacy benefits law, labor and employment law and commercial and technology agreements.

Developed internal compliance programs and ensured compliance with applicable company policies and procedures

Provided complex legal and health policy advice on issues including Medicare/Medicaid, payment systems and reimbursement, managed care contracting, licensing and accreditation, quality improvement, risk management and fraud and abuse.

Solved state licensure and disciplinary issues for pharmacies, pharmacists and wholesalers before multiple state boards of pharmacy.

Advised compounding pharmacies and outsourcing facilities with regulatory matters.

Advised pharmaceutical manufacturers on FDA matters including pedigree, and state pharmacy/distribution laws.

  • University of Illinois at Chicago, MPH, Health Policy & Administration, 2000
  • Chicago-Kent College of Law, Illinois Institute of Technology, JD, 1996
  • Indiana University, BA, Political Science and English Literature, 1992

Member, American Health Lawyers Association

Member, American Society of Pharmacy Law

Member, Health Care Compliance Association

Member, Illinois Association of Healthcare Attorneys

  • Illinois
  • Supreme Court of Illinois
  • U.S. Court of Appeals for the 7th Circuit
  • U.S. District Court for the Northern District of Illinois

Recipient of Faculty Scholarship and Centennial Scholarship, University of Illinois-Chicago, 2000

Recipient of Phi Alpha Delta International Service Scholarship, IIT Chicago-Kent College of Law, 1996

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