We are living in an era of unprecedented change in the drug and pharmacy industry. Drug manufacturers, wholesale distributors and pharmacies are facing greater patient demand. Intense competition, growing state and federal regulatory oversight, and shrinking profit margins are challenging supply chain stakeholders. And new delivery system technology and innovations in research and development present both opportunities and obstacles.

The health care team at Much Shelist includes attorneys with in-depth knowledge of the entire drug and pharmacy supply chain. We provide pharmacies, health care providers, technology companies and other entities with essential business counseling, transactional, regulatory compliance, government affairs counseling and litigation services. Our clients include major drug manufacturers, pharmacies and national health systems, as well as third-party logistics providers, startup technology and research companies, pharmacy benefit managers, individual physician practices, and other for-profit and not-for-profit entities.

The head of our Drug & Pharmacy practice holds a PharmD and began his professional life as a practicing pharmacist. That knowledge and experience have made us a “go to” legal team for many clients. We understand the unique issues that face industry participants, including licensing, data privacy, advertising, clinical trials, counterfeiting, product recalls, reimbursements and related concerns. At the state and local level, our attorneys have represented clients before numerous boards of pharmacy, departments of health and related agencies. We also represent clients before federal regulators and law-enforcement officials, including the U.S. Food and Drug Administration, the Drug Enforcement Administration, the Centers for Medicare and Medicaid Services, the Medicaid Fraud Unit, and the Department of Justice. As experienced lawyers and counselors, we also provide resolution-focused results in all forms of commercial and regulatory disputes and venues, including trials, arbitration and mediation.

We provide experienced counsel in the following areas of drug and pharmacy law:

  • Administrative and regulatory compliance

  • Audits

  • Buy and sell transactions

  • Congressional inquiries

  • DEA registration matters

  • Electronic prescribing

  • Federal Trade Commission requirements

  • Government investigations

  • In-store clinics
  • Licensing and certification

  • Management agreements

  • Medicare and Medicaid reimbursement

  • Pedigree issues

  • Specialty pharmacy matters

  • State consumer protection laws

  • U.S. Food and Drug Administration regulations

  • Vendor agreements

In addition to industry-specific concerns, pharmacies, providers and other health care companies must also manage a broad range of general business issues. Our attorneys work closely with lawyers throughout the firm’s numerous practice areas. This collaborative approach helps our clients proactively identify business opportunities, manage employees, minimize financial and regulatory risks, and resolve disputes with customers, vendors, business partners and others. Our key general business services include the following:

  • ERISA compliance

  • Estate and succession planning

  • Labor and employment

  • Litigation and conflict resolution

  • Mergers, acquisitions and corporate transactions

  • Real estate

We are committed to staying ahead of industry and regulatory trends, and are highly involved in a number of drug and pharmacy industry organizations. We publish columns in leading trade journals, and we frequently speak at industry conferences and seminars. Our active involvement in the pharmaceutical industry gives us the access and insights that help our client’s seize the opportunities and address the problems they face every day.