Pharmaceuticals and Biotechnology

Holland & Knight's Pharmaceuticals and Biotechnology Team takes a comprehensive, multidisciplinary approach to serving the needs of clients throughout the industry. Our attorneys have the breadth of legal experience essential for dealing effectively with increasingly complex biotech regulatory and policy challenges throughout a product's life cycle.

We have a broad range of experience counseling clients on the U.S. Food and Drug Administration's (FDA) review of New Drug Applications (NDAs) and issues involving the FDA Center for Biologics Evaluation and Research (CBER), from the investigational new drug (IND) stage through post-approval and marketing and on issues such as post-market reporting obligations, product recalls, product labeling, establishment registration, compliance plans, and product sales and distribution requirements.

Our attorneys help pharmaceutical and biotechnology manufacturers navigate the complex regulatory landscape, allowing them to take best advantage under existing laws and policies while working to shape new policies that reflect today's complex economic realities. We work with clients on matters involving Medicare, pricing, contracting, rebates and patient assistance programs, including negotiating with payers to cover and approve new products, as well as structuring and implementing marketing and sales practices to comply with the federal Anti-Kickback Statute (AKS) and related laws and regulations.

Experience and Technical Know-How

Our Pharmaceuticals and Biotechnology Team has a keen understanding of our clients' needs and works diligently in guiding them to practical solutions. Our lawyers' deep experience, technical know-how and knowledge of the industry helps pharmaceutical and biotechnology clients resolve challenges in compliance, reimbursement and transactions, including the assessment of intellectual property values. We also advise on the licensing, ownership and change of control requirements that vary significantly by state.

Holland & Knight's Pharmaceuticals and Biotechnology Team has extensive experience assisting clients resolve a wide range of legal challenges, including the following.

FDA and Related Issues

• Advising on clinical trial design and regulation for investigational new drug (IND) filings, Institutional Review Boards (IRBs) submissions and review, clinical holds, voluntary principles on the conduct of trials, public clinical trial data banks and clinical hold procedures, preparation and staffing for FDA meetings, biologics license application (BLA) submissions, claims, advertising and promotion and other post-market requirements
• Advising on platform technology designations and related issues
• Providing counsel on user fees and related FDA performance goals and procedures
• Assisting with Prescription Drug Marketing Act and supply chain issues, such as importation, e-commerce, counterfeiting, wholesalers and pedigree requirements, and radio frequency identification (RFID) policy and technology
• Advising on marketing and labeling issues, advertising and protected speech aspects, including on/off label marketing
• Providing guidance on voluntary codes regarding marketing practices and interaction with healthcare professionals, as well as continuing medical education
• Advising on over-the-counter (OTC) drug monographs and prescription to nonprescription (Rx-OTC) switch issues
• Lobbying Congress on major FDA, Medicare and drug importation legislation
• Creating coalitions of interested organizations for advocating before the FDA
• Applying for Emergency Use Authorization (EUA) for a product, including responding to the FDA's follow-up questions and separate scrutiny of the company's claims about its product
• Advising on FDA regulations, responses to audits as a federal contractor and government relations for companies developing clinical tests and administering vaccines
• Advising on FDA expedited review programs such as Fast Track Designation, Breakthrough Designation, Regenerative Medicine Advanced Therapy, Priority Review and Accelerated Approval
• Advising on FDA rules governing exporting and importing products

Pharmaceutical and Biotechnology Regulatory Compliance

• Providing regulatory guidance and advice on matters concerning compliance with the federal AKS, the Stark law, Medicare, Medicaid, Physician Payments Sunshine Act, corporate practice of medicine, and other federal and state healthcare laws
• Drafting policies and procedures and implementing compliance programs
• Conducting in-depth sales and marketing training, providing day-to-day advice on marketing regulations and reviewing marketing or promotional materials
• Appealing Medicare and state Medicaid payment audits
• Serving as a pharmaceutical company's interim compliance officer and overseeing the hiring and training of a new full-time officer
• Advising pharmaceutical manufacturers and biotechnology companies on how items and services are covered, paid for and reimbursed within various payment programs, including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), Affordable Care Act exchanges and nontraditional value-based care payment methods
• Negotiating with different programs and payers for coverage and approval of clients' products
• Advising on issues related to supply chain/logistics, quality assurance and corporate compliance, as well as counseling on advertising and promotion, website development and claims made by companies about their products
• Reviewing and structuring rebate arrangements, discount arrangements, reimbursement strategies and other patient assistance programs, including 340B, copay assistance programs and other mechanisms to reduce the cost of drugs
• Representing clients in government investigations and responding to civil investigative demands (CIDs)
• Analyzing merits of the government's cases and assisting with response drafting and document production
• Addressing compliance concerns related to litigation

Pharmaceutical and Biotechnology IP Matters

• Assessing IP asset value of companies being bought or sold, including strength of patents against potential competitors
• Consulting on formulations for patent strength, including suggestions of "design arounds"
• Advising universities, research institutes and biopharmaceutical companies on complicated, multilayered license agreements for cellular tissue and other materials in various stages of scientific development and patent prosecution
• Advising on the scrutiny of generic-innovator competition by the Federal Trade Commission and U.S. Department of Justice

Reimbursement and Managed Care Contracting

As more providers and payers consider value-based care (VBC) models and risk-sharing agreements, the complexity of payor contracts has increased, making the need for experienced healthcare counsel more critical. Holland & Knight's Value-Based Care Team assists with accountable care organizations (ACOs) and CMS Innovation Center models, bundled payment arrangements and shared savings/shared risk arrangements.

Our experience includes representing clients in contract negotiations between plans and providers, plans and their customers, and plans and their vendors. Our lawyers provide counsel on information and data sharing agreements between VBC participants that can significantly impact the success of value-based care models. Our experience includes negotiating value-based contracts that support population health management activities and other goals.