Holland & Knight

Overview

Holland & Knight is a global law firm with healthcare and life-sciences practices serving pharmaceutical, biotech, pharmacy, PBM, health-system, and healthcare-technology clients. For a manufacturer buyer, the relevant lane is legal counsel: FDA and life-sciences regulatory advice, healthcare enforcement, pharmacy / PBM / 340B law, Medicare and Medicaid reimbursement policy, IRA and drug-pricing policy, healthcare AI, HIPAA / privacy, clinical-research compliance, transactions, licensing, and commercial contracting.

It should not be evaluated like an operational regulatory vendor. Holland & Knight does not belong in the same comparison set as pharmacovigilance case-processing vendors, safety databases, quality-system managed-service firms, prior-authorization workflow platforms, hub operators, or reimbursement processors. Use the profile when the launch, access, transaction, or commercialization issue is legal, policy-driven, contractual, regulatory, or litigation-sensitive.

Regulatory Compliance Capability Model

The framework below standardizes how Rx Almanac evaluates regulatory-compliance capabilities, so buyers can compare vendors like-for-like while the readout column stays vendor-specific. For this table, Holland & Knight is evaluated as an advisory, policy, transaction, and litigation partner, not a managed-service operations vendor.

Capability	Buyer should compare	Holland & Knight readout
Regulatory strategy and submissions	Submission planning, agency interactions, labeling strategy, variations, lifecycle management, and global filing support.	Core regulatory support. Holland & Knight publicly markets healthcare and pharma / biotech practices, and its current public thought leadership covers FDA reform, drug-review transparency, AI, and regulatory modernization.
Pharmacovigilance and safety operations	ICSR intake, case processing, signal detection, aggregate reports, REMS/safety support, and safety databases.	Not the use case. Treat these as out of scope unless Holland & Knight is advising on legal risk around another vendor’s operations.
Quality systems and compliance auditing	GxP quality systems, SOPs, audits, inspection readiness, CAPA, vendor oversight, and training.	Documented, validate scope. The firm has healthcare litigation and enforcement capabilities; buyers should confirm the exact team, jurisdiction, and matter analogs.
Labeling, promotional review, and medical/legal support	Label operations, MLR review, promotional compliance, medical information, and claims substantiation.	Not the main buying reason for Holland & Knight; validate only if the SOW includes labeling, promotional review, and medical/legal support.
Licensing, accreditation, and specialized counsel	Pharmacy, PBM, state licensing, accreditation, healthcare law, and niche regulatory counsel.	Core PA casework. The better buyer read is legal and policy counsel, not prior-authorization or reimbursement operations. Core access strategy. Holland & Knight fits when a pharma-services transaction or access contract needs legal structuring, diligence, or negotiation.
Technology, workflow, and reporting infrastructure	Validated systems, regulatory information management, safety platforms, dashboards, and workflow automation.	Automation workflow. The firm publishes healthcare AI and compliance guidance, including a Health AI Navigator; this is legal guidance, not operating software for manufacturers.

Buyer Fit

• Launch-team fit: Include Holland & Knight when the work requires legal interpretation, regulatory counsel, policy monitoring, enforcement defense, transaction support, or contract negotiation across life sciences, healthcare, pharmacy, PBM, 340B, Medicare, Medicaid, or FDA-regulated products.
• Strongest use cases: FDA policy and product-lifecycle questions, 340B and pharmacy law, PBM reform, IRA / Medicare negotiation, Medicaid prescription-drug policy, drug-pricing policy, healthcare AI governance, HIPAA / privacy, healthcare fraud-and-abuse, specialty-pharmacy / PBM contracting, life-sciences M&A, licensing, and collaboration agreements.
• Market access fit: Use as legal counsel for PBM, pharmacy, reimbursement, formulary, 340B, contracting, IRA / MFN, Medicare, Medicaid, and state/federal reform issues; pair with market-access consultants when the work requires payer research, GTN modeling, value messaging, or access strategy execution.
• Not a fit for: PV case processing, safety operations, prior authorization automation, hub services, benefits verification, copay operations, regulatory information management software, or routine reimbursement processing.
• Commercial fit: Pricing is custom / matter-based. Buyers should scope partner involvement, associate leverage, jurisdiction coverage, response timelines, conflicts, local-counsel needs, and privilege strategy.

Differentiators

• Healthcare and life-sciences scale: Holland & Knight has a large national healthcare practice and public Law360 recognition for healthcare work.
• Pharmacy / PBM / 340B policy signal: The firm publishes and advises around PBM scrutiny, pharmacy law, 340B, Medicare, Medicaid, IRA, MFN pricing, and drug-pricing policy.
• Healthcare AI and technology coverage: Health AI Navigator and healthcare technology guidance give the firm a legal-risk lens on AI, privacy, clinical, and digital-health adoption.
• Transaction capability: Holland & Knight can pair regulatory, reimbursement, public-policy, healthcare, employment, privacy, IP, and corporate counsel for life-sciences transactions and commercialization contracts.

RFP Questions

• Which partner will be accountable for the matter, and what similar pharma / biotech / pharmacy / PBM matters have they handled?
• How does the team have the right mix of FDA, healthcare, pharmacy, PBM, 340B, reimbursement-policy, privacy, enforcement, and transaction experience for the issue?
• How will Holland & Knight coordinate with internal counsel, market-access consultants, agencies, hub vendors, specialty pharmacies, or operational compliance vendors?
• What work is legal advice versus operational execution that must be handled by another vendor?
• What conflicts, state-law limits, local-counsel needs, privilege considerations, and public-policy sensitivities should be resolved before engagement?
• How will budget, staffing leverage, timelines, escalation, and deliverable ownership be controlled?

Recent Activity

• May 2026: Published healthcare policy and Health Dose materials covering FDA policy shifts, IRA Medicare drug negotiations, Medicaid prescription-drug models, healthcare AI, and pharmaceutical onshoring / tariff relief.
• January 2026: Public coverage named Holland & Knight a Healthcare Group of the Year for 2025.
• 2025-2026: Continued public coverage of 340B, PBM reform, drug-pricing policy, healthcare fraud enforcement, CMS payment policy, and healthcare / life-sciences transactions.