Pharmaceutical wholesalers, distributors, and group purchasing organizations (GPOs) operate at the center of the pharmaceutical supply chain and face increasing regulatory scrutiny, pricing pressure, and contractual complexity. Federal and state enforcement agencies continue to focus on drug distribution practices, DSCSA compliance, pricing arrangements, and financial relationships among manufacturers, pharmacies, and providers.
Frier Levitt advises pharmaceutical wholesalers, distributors, and GPOs nationwide on regulatory compliance, contracting, transactions, audits, investigations, and disputes. Our healthcare and life sciences attorneys combine deep regulatory experience with practical industry insight to help clients manage risk, maintain compliance, and support business growth in a highly regulated environment.
Regulatory and Compliance Counsel
We provide ongoing regulatory and compliance guidance tailored to the operational realities of pharmaceutical distribution and purchasing organizations. Our attorneys advise on federal and state laws governing drug distribution, pricing, and financial relationships across the supply chain.
Our regulatory and compliance services include:
- Drug Supply Chain Security Act (DSCSA) compliance, serialization, tracing, and verification
- Federal and state wholesale distributor and third-party logistics provider (3PL) registration
- Anti-Kickback Statute, Stark Law, and state fraud and abuse laws
- Pricing, chargebacks, rebates, and discount arrangements
- Fee-splitting, remuneration, and referral risk analysis
- Compliance program development, policies, and procedures
Contracting, Transactions, and Business Structuring
We assist wholesalers, distributors, and GPOs with the structuring and negotiation of core commercial relationships while addressing regulatory, pricing, and compliance risk. Our attorneys work closely with clients to align legal frameworks with operational and financial objectives.
Our services include:
- Manufacturer, supplier, and vendor agreements
- Distribution, supply, and services agreements
- GPO participation, vendor, and administrative arrangements
- Data use, data sharing, and technology-enabled distribution models
- Mergers, acquisitions, joint ventures, and strategic affiliations
- Regulatory and licensing due diligence
Audits, Investigations, and Enforcement Defense
Wholesalers, distributors, and GPOs are increasingly subject to audits and investigations by federal and state agencies. We represent clients in responding to audit demands, government inquiries, and enforcement actions, with a focus on minimizing disruption and mitigating regulatory exposure.
Our experience includes:
- Government audits and investigations
- Civil and administrative enforcement actions
- Licensing actions and disciplinary proceedings
- Compliance remediation and corrective action planning
- Internal investigations and risk assessments
Litigation and Dispute Resolution
When disputes arise, Frier Levitt represents pharmaceutical wholesalers, distributors, and GPOs in complex commercial litigation and regulatory investigations. Our litigation strategy is informed by deep regulatory knowledge and a practical understanding of the pharmaceutical supply chain.
Our litigation experience includes:
- Contract and commercial disputes
- Manufacturer, supplier, and customer disputes
- Regulatory and licensing-related investigations and prosecutions
- Pricing, reimbursement, and audit-related disputes
How Frier Levitt Can Help
Frier Levitt’s healthcare and life sciences attorneys understand how pharmaceutical distribution, reimbursement, and regulation intersect. We deliver practical, risk-based guidance that reflects current enforcement trends, evolving regulatory requirements, and the operational demands facing wholesalers, distributors, and GPOs.
If you are navigating regulatory compliance, transactional matters, audits, investigations, or disputes affecting your distribution or purchasing operations, Frier Levitt can provide strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.
