Life Sciences Policy, Government Relations and Regulatory Compliance

Holland & Knight lawyers and professionals are well versed in the niche practice of serving the full policy, government relations and regulatory compliance needs of life sciences companies.

Clients across the life sciences spectrum turn to Holland & Knight's Life Sciences Policy, Government Relations and Regulatory Compliance Team to advocate their interests before state and federal lawmakers and legislators. Our experience includes the formation of coalitions to advance client healthcare and life sciences priorities. We combine our political acumen and relationships with second-to-none regulatory and issue knowledge of the healthcare sector and its regulated industries.

Our team's extensive experience includes the development and execution of integrated strategies that leverage our attorneys' and professionals' substantial regulatory knowledge. This enables life sciences companies to develop, manufacture, market and distribute medical devices, prescription drugs, biologics, combination products, biosimilars, over-the-counter (OTC) drugs, dietary supplements and other products regulated by the U.S. Food and Drug Administration (FDA) with the assurance that they are complying with federal regulations as well as applicable state laws.

FDA Policy and Government Relations

Our attorneys and policy professionals provide full-service, turn-key government strategy solutions that champion our clients' objectives. Our integrated team includes individuals with legal and policy experience who work tirelessly to create positive change for our clients and help meet the challenges posed by today's rapidly evolving healthcare environment.

Our attorneys and policy professionals understand our clients' businesses and goals, anticipate problems and challenges, and formulate sound strategies based on what is politically achievable. Then, through lobbying and leveraging our key relationships with Congress, the White House and across the executive branch, we execute those strategies to help advance our clients' interests.

We have deep policy knowledge and a developed understanding of the intersection between policy, regulatory matters, public affairs and coalition building. This includes comprehensive experience in legislative drafting and analysis, development of regulatory strategies, identifying and securing federal funding, and policy forecasting that informs client business plan development. Key to our success is our ability to translate complex legal and regulatory issues into a practical, real-world framework to help find solutions to some of healthcare's and the life sciences industry's most challenging problems.

Our team is bipartisan and collaborative, and has strong working relationships with key healthcare and life sciences decision-makers on Capitol Hill, the FDA, the Centers for Medicare & Medicaid Services (CMS), and political and career officials at the U.S. Department of Health and Human Services (HHS). Our collective reach spans the entirety of the memberships of the key healthcare authorizing and appropriating bodies, including the Senate Health, Education, Labor and Pensions (HELP) Committee, Senate Finance Committee, House and Senate Appropriations Committees, House Energy and Commerce Committee, and House Ways and Means Committee. Holland & Knight also has extensive experience preparing clients for testimony before relevant congressional committees on behalf of clients and their interests numerous times on diverse healthcare and life sciences topics.

Our experience in life sciences policy matters includes the following:

• Leading the design of Medicare's Inpatient Prospective Payment System (IPPS) New Technology Add-On Payments (NTAP) for innovative products covering multiple therapeutic areas, including regenerative medicine, cellular therapies and neurological disorders, leading to a needed increase in reimbursement for these novel therapies while establishing a basis for CMS consideration of permanent reimbursement increases for the products in the future.
• Organizing and managing a multi-stakeholder coalition that secured changes in the Food, Drug, and Cosmetic Act and created a new market pathway for OTC products (sunscreen).
• Working with stakeholders to advocate for a change in Medicare and Medicaid policies, as well as CMS legal policies, that would allow for novel payment designs for innovative products in the context of the drug pricing debate in the 116th Congress. These interventions would allow for value-based payment arrangements for certain innovative products without violating long-standing healthcare legal constructs such as Stark Law or the Anti-Kickback Statute (AKS).
• Founded a leading industry coalition that successfully enacted language establishing an expedited approval pathway for cell and gene therapy products. This work further prompted the FDA to issue new guidelines to expedite the introduction of these therapies. Holland & Knight continues to lead policy development and advocacy in this sector, while also consulting on the pathway's effects on individual products in the gene and cellular therapy space.
• Obtaining substantial federal funding for client-specific medical research initiatives, U.S. Department of Defense (DOD) health programs and research, and discrete public health programs within the Centers for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA) and the HHS Assistant Secretary for Preparedness and Response.

FDA Representation and Regulatory Compliance

Holland & Knight attorneys literally "wrote the book" on FDA regulatory compliance, co-authoring Life Sciences Compliance: A Pre-Market and Post-Market Road Map published by Bloomberg. Holland & Knight's Life Sciences Team has extensive experience in the following areas:

• representing companies in meetings with FDA officials
• negotiating terms of clinical trial agreements with research institutions and investigators
• helping companies assess and navigate the regulatory pathway to market for novel technologies
• advising companies on FDA marketing rules and labeling claims
• advising companies on compliance with FDA regulations
• counseling and representing companies before the FDA on voluntary recalls
• counseling clients during inspections and post-inspection matters, responses to FDA Form 483s, untitled and warning letters, and other enforcement actions
• performing "regulatory due diligence" for investors in biotechnology and medical device companies
• advising companies on pre-market and post-market regulatory strategies, including product classification
• counseling life sciences companies on good manufacturing practice (GMP) requirements as well as manufacturing and supply chain issues
• assisting companies in the user fee renewal process for multiple types of products and consulting on user fee issues related to prescription drugs, medical devices and biosimilars