Specialty Pharmacy & Pharmaceuticals

With 20 attorneys, we have one of the largest Specialty Pharmacy & Pharmaceuticals Practices in the country. Led by industry veterans who have experience as both in-house general counsel and outside counsel for national pharmacy, pharma service and pharmacy benefit management companies, our multi-disciplinary team serves as operational and transactional counsel to a majority of the nation’s largest specialty pharmacies.

We are regularly engaged in significant transactions in the specialty pharmacy industry. We also provide practical business advice and legal guidance to help with trade and distribution matters facing clients within the pharmaceutical industry. Day-to-day, we assist clients in navigating and complying with the contractual, regulatory and operational requirements unique to the pharmaceutical industry, and we lead clients in audits and compliance reviews.

We counsel a variety of clients including:

  • Large and small specialty and home infusion pharmacies
  • Large and small specialty drug manufacturers
  • Private equity firms
  • Specialty Drug Distributors
  • Group purchasing organizations (GPOs)
  • Reimbursement hubs, prior authorization programs, financial assistance programs, and other pharma services companies
  • 340B covered entities

Areas of Focus

  • Compliance & Investigations
    • Addressing enforcement and compliance issues as well as responding to legal and regulatory violations.
    • Advising on healthcare liability and risk management issues.
    • Advising on issues associated with implementing new reimbursement, prior authorization support, financial assistance and other pharma services and programs for limited distribution specialty drugs.
  • Contracting, Regulatory & Operational
    • Guiding parties in moving new products from manufacturing to market, such as handling the business needs of the manufacturer, as well as negotiating agreements with various entities through the supply chain.
    • Negotiating, designing and contracting distribution networks.
    • Advising on multiple patient assistance, co-pay waiver and coupon programs.
    • Counseling manufacturers and pharmacies in moving drugs from the manufacturer to the pharmacy, physician or hospital, including structuring compliant GPO arrangements and negotiating contracts for administrative service fees and rebates.
    • Assisting in designing, negotiating and contracting protocol management programs including integration of pharmaceutical products into protocol programs.
    • Managing complex, licensure issues including multi-pharmacy change of ownership (CHOW) projects in all 50 states.
    • Supporting the contracting of preferred exclusive specialty pharmacy provider networks with payors, including national and regional health plans and pharmacy benefit managers.
  • Disputes
    • Providing dispute resolution strategies and support for contracting and reimbursement issues.
    • Enforcing non-competes and other business protection strategies.
  • Mergers, Acquisitions & Dispositions
    • Supporting the evaluation, bid process and diligence involved in specialty pharmacy mergers and acquisitions by:
      • Identifying and analyzing risks associated with specialty pharmacy companies involved in transactions.
      • Analyzing regulatory implications of mergers and acquisitions and addressing issues related to dispositions.
    • Leading negotiations for mergers, tender offers, and stock and asset purchases and divestitures (both tax-free and taxable).
    • Structuring spinoffs and recapitalizations, management buyouts and other going-private transactions.
Philip F. Berg
Senior Healthcare Attorney
Brian D. Bewley
Member
Meredith Edwards Collins
Associate
Jeanne Marie Evans
Associate
Mallory Farrar
Associate
Mary Beth Fortugno
Member
Louise P. Gaerig
Senior Healthcare Attorney
Courtney Ginn
Associate
Anna M. Grizzle
Member
Michael R. Hess
Member
J. James Jenkins, Jr.
Member
Kris Kemp
Member
David A. King
Member
Amy Sanders Morgan
Associate
Elaine C. Naughton
Associate
Jason Northcutt
Member
Frank M. Pellegrino
Member
Cynthia Y. Reisz
Member
H. Shine Chen Schattgen
Associate
Gina R. Shockley
Brian L. Sims
Associate
Danielle M. Sloane
Member
Jamie Gordon Steakley
Associate
Julia Tamulis
Associate
Ryan D. Thomas
Member
Ashley N. Thurman
Associate
Quyen Vo
Associate
Elizabeth S. Warren
Member
Shannon L. Wiley
Associate

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