Pharmaceutical, Biotechnology and Medical Device Industries
- Our Healthcare & Life Sciences Team has extensive regulatory experience, including FDA experience from initial drug review through post-approval and marketing, FDA-related intellectual property matters and involvement in the development of major regulations, such as the Medicare Modernization Act of 2003 and the Public Health Security and Bioterrorism Act of 2002.
- Our team's comprehensive approach ensures you have the right attorneys to guide you through every legal step in the product lifecycle.
- Our lawyers maintain established working relationships at the Center for Devices and Radiological Health, where we have helped craft major legislation and worked hand-in-hand with our clients to ensure the safety of radiological products throughout the United States.
The Healthcare and Life Sciences Team at Holland & Knight takes a comprehensive, multidisciplinary approach to serving the needs of pharmaceutical, biotechnology and medical device manufacturers. We have the range of legal experience essential to dealing effectively, throughout a product’s life cycle, with today’s increasingly complex regulatory and policy challenges, many of which are driven by the U.S. Food & Drug Administration (FDA), as well as the Centers for Medicare and Medicaid Services (CMS). This experience includes business planning and startup, finance and M&A; healthcare regulatory matters, including public and private reimbursement issues; federal and state legislation and appropriations; intellectual property; litigation (including mass tort defense); and strategic communications.
Our team draws upon the firm’s considerable resources, including major offices in Washington, D.C., New York, Boston, Atlanta, Chicago, San Francisco, Los Angeles and throughout Florida.
To maximize your opportunity to prevail on an issue, we assemble focused teams of attorneys to blend the necessary substantive knowledge with the procedural know-how to move the matter through the litigation process, the legislative process, or the regulatory process. Whether a matter requires informal consultation with agency or congressional staff, participation in public meetings, advocacy for particular report or bill language, or the preparation of comments on proposed rules or guidances, we have the talent and resources to get the job done effectively and efficiently.
Our ability to serve this sector of the healthcare industry is bolstered by the depth of our FDA-related experience.
Sample FDA Practice Areas and Experience
Our team has a range of experience counseling clients on the review of New Drug and Biologics License Applications (NDAs and BLAs) including, from the Investigational New Drug (IND) stage through post-approval and marketing. Specifically, we have dealt with the following:
- clinical trials – INDs, Institutional Review Boards (IRBs), clinical holds, voluntary principles on the conduct of trials, public clinical trial data banks and clinical hold procedures
- user fees and related FDA performance goals and procedures
- Prescription Drug Marketing Act and supply chain issues – importation, e-commerce, counterfeit, wholesalers and pedigree requirements, and RFID policy and technology
- marketing and labeling issues – advertising and protected speech aspects, including on/off label
- voluntary codes regarding marketing practices and interaction with health care professionals, and Continuing Medical Education
- Over-the-Counter (OTC) drug monographs and Rx-OTC switch issues
- vaccines and medical gases
Center for Devices and Radiological Health
We have worked closely with CDRH as it continues to ensure the safety and effectiveness of medical devices and the safety of radiological products throughout the United States. Specifically, we have dealt with the following:
- development and implementation of the Medical Device User Fee and Modernization Act
- clearance and approval strategies for medical devices and combination products
- clinical trial design, IRB approvals and investigational device exemptions
- labeling, relabeling and repackaging requirements
- defense of FDA-initiated enforcement actions and inspections
FDA-Related Intellectual Property Matters
The Healthcare Team is comprised of Holland & Knight intellectual property litigators and prosecutors, including patent attorneys and agents with advanced degrees in science and engineering. Our lawyers have handled matters relevant to FDA and the healthcare industry including:
- scrutiny of generic-innovator competition by the Federal Trade Commission and Department of Justice, and the intersection of IP and antitrust law
- trademarks and related labeling issues
Major FDA Legislation
Team members have been involved in the development of most major FDA-related legislation in recent years including:
- Medicare Modernization Act of 2003 – Rx drug benefit; discount card program; importation and affordability
- Public Health Security and Bioterrorism Act of 2002
- prescription drug user fee reauthorizations of 1997 and 2002
- Medical Device User Fee and Modernization Act of 2002
- FDA Modernization Act of 1997
- Export Reform Act of 1996
- drug importation legislation