Health - Product Regulation
Our Health Products Regulation Practice focuses on the needs of both health product manufacturers and providers. Lawyers in our Group have held senior positions in the government and the health care services, products and health insurance industries. With our broad based health law practice, we bring our representation of health product manufacturers an understanding of the health products marketplace and of the market regulatory bodies of new and existing health products. Our lawyers counsel clients ranging from multinational to small start-up companies on product issues relating to food, drugs and medical devices, reimbursement standards, outcomes research and intellectual property.
Our Productions Regulation Group consists of an interdisciplinary team of lawyers which focus on food and drugs, health products reimbursement and health outcomes research. Our Group also works very closely with the Firm’s Intellectual Property Department to file and prosecute patents, secure trademarks and copyrights; defend patents and interferences and counsel and litigate regarding the Lanham Act.
Regulatory and legal staff can work together in efforts such as research and marketing. Unified counseling avoids costly regulatory surprises and minimizes duplicate legal fees. Our clients can maximize their business objectives and focus on intellectual property, FDA and reimbursement matters because of gains achieved with our practice-focused legal team.
REPRESENTATIVE EXPERIENCE
Food & Drug
Business planning, marketing applications, assistance with policies and procedures, promotional campaigns, inspections and defense of regulatory actions, response to Warning Letters, notices of violation. Also, all aspects of pharmacy law, including licensing and dispensing issues.
Health Products Reimbursement
Evaluation of the payment and coverage environment; obtaining new payment codes; development of reimbursement materials for use in marketing and sales.
Outcomes Research
Design, implementation and distribution of studies demonstrating the value (cost effectiveness) of new products and related procedures; develop and present outcomes research data to government regulators, providers and third-party payors; and assist with the development of marketing campaigns to disseminate outcomes research messages for new products.
Intellectual Property
File and prosecution of patents, secure trademarks and copyrights; patent defenses and interferences, Lanham Act counseling and litigation.
AREAS OF ASSISTANCE
- Selection of the data to generate or accumulate to support marketing applications, promotional claims and reimbursement strategies
- Production of approvable marketing applications and move them through the FDA review process
- Development and adoption of necessary policies and procedures for testing, manufacturing, quality assurance, packaging and labeling
- Implementation of promotional campaigns which withstand challenge from the regulators
- Securing governmental and third-party coverage and reimbursement for products and develop mutually beneficial supply marketing agreements with managed care entities
- Obtainment and protection of favorable formulary status for pharmaceuticals
- Development of data to demonstrate the cost-effectiveness of products
- Handling inspections and defense in any regulatory action in any forum
- Lobbying before Congress for needed regulatory and economic changes in existing laws
- Patenting products, registering marks and protection of intellectual property from unlawful interference
Contacts
- Robert B. Nicholas
+1 202 756 8170
Send E-mail
Health Client Services
- Academic Medical Centers
- Ambulatory Surgery Centers (ASC)
- Catholic Organizations
- Conflicts of Interest - Health
- Consumer-Driven Health Care
- Health - Antitrust
- Health - General Counsel
- Health - Information Systems
