简介

Julie Letwat provides companies across the health care industry wide-ranging guidance grounded in years of experience as legal counsel for health care organizations. She is particularly adept at health care regulations and compliance, negotiation, communication strategy, government advocacy, market analysis and business strategy.

Julie's experience includes: 

  • Pharmacies, including compounding, specialty and retail pharmacies
  • Pharmacy benefits management and services Drug Quality and Security Act and state pharmacy law
  • Food & Drug Administration (FDA) and Drug Enforcement Agency (DEA) compliance
  • Market access and analysis, payment reform and reimbursement
  • Medicare Part D/formulary management
  • Strategic transactional matters, including mergers and acquisitions (Pedigree/import requirements for registration and APIs)
  • Government affairs, policy and legislative advocacy
  • FDA inspections, enforcement letters and product recalls
  • Drug promotion and interactions with health care professionals 
  • Sunshine Act/Open Payments
  • Telemedicine/Digital Health
  • State and federal health care regulations

Health Care Counsel

Prior to joining Faegre Baker Daniels, Julie spent nearly two decades providing legal counsel to various health care organizations, including terms at the American Medical Association, a national specialty pharmacy, and, most recently, as general counsel and VP at a global leader in pharmaceutical wholesaling and compounding. In these roles, she resolved issues quickly, effectively and unobtrusively, so as not to interfere with day-to-day operations.

Government Affairs

Julie spent time as a registered lobbyist and head of government affairs for two major pharmaceutical companies, one of which focused almost exclusively on regenerative medicine and wound care. Julie has worked closely on all the issues surrounding commercialization of transformational treatments and technologies, including biologics, chemical compounds and devices.

资质

执业资格

Illinois

出庭资格

Illinois Supreme Court
U.S. Court of Appeals for the Seventh Circuit
U.S. District Court for the Northern District of Illinois

教育

University of Illinois at Chicago
M.P.H. in Health Policy & Administration (2000)

Chicago-Kent College of Law
J.D. Health Law concentration (1996)

Indiana University
B.A. in Political Science and English Literature (1992)

见解和活动

其他角度
  • Issues to Consider for 503B Outsourcing Facilities
    CriticalPoint LLC, Webinar, November 8, 2017
  • Navigate the Major Compliance Issues around Formularies
    CBI Managed Markets Compliance Conference, Philadelphia, December 5, 2017
  • State of the Union for Pharmacies on Drug Quality & Security Act (DSQA)
    National Pharmacy Purchasing Association, Las Vegas, August 23, 2017
  • Regulatory Update and Compliance for Your Pharmacy
    Freedom’s 4th Annual Seminar, Denver, September 18, 2015
  • Relationships with Compounding Pharmacies: What is Permissible?
    Georgia State Pharmacy Meeting, Atlanta, February 2014
  • Working with Advocates to Overcome Payer Resistance
    BIOCOM Reimbursement Series, November 9, 2010
  • 21st Century Healthcare
    AdvaMed 2010, Washington DC, October 2010
  • The Current Quality of Health Plan Report Cards
    Author, The Journal of Medical Systems, Vol. 23, No.4, October 1999

领导力和社区

职业协会

  • Pinpoint Opportunity Fund, LLC – Board of Advisors
  • Illinois Association of Healthcare Attorneys
  • American Society of Pharmacy Law
  • American Health Lawyers Association
  • Health Care Businesswomen’s Association
  • Health Care Compliance Association

荣誉

  • Provider Primary Liaison to American Accreditation Health Care Commission/URAC
  • Recipient, Phi Alpha Delta International Service Scholarship
  • President’s Recognition of Outstanding Students Award
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