Food and Drug Administration Practice
Regulatory and Administrative Law
We assist life sciences and health care clients in complying with, and enforcing their rights under federal, state and foreign regulations and guidelines. Our regulatory work includes counseling with regard to the regulatory impact on deal structure, licensure, IRB approvals, scientific integrity rules, FDA and EPA rules and regulations, grant funding, reimbursement, compensation methodologies, antitrust and price fixing, stem cell research, import/export and international trade laws, FTC rules and regulations (relating to marketing, advertising, packaging, labeling and promotions), Lanham Act remedies (relating to counterfeiting, parallel imports, and illegal compounding), immigration law, Medicare/Medicaid anti-kickback, physician self-referral and Certificate of Need issues. We also provide advice and assistance in analyzing the impact of various federal and state consumer protection and privacy laws and regulations, including HIPAA, for a range of clients who access or use individual health information. Our regulatory work also includes tax counseling in connection with transactional and tax exemption matters. In addition, we help clients in navigating governmental life sciences and health care initiatives, engaging in the political process on important life sciences and health care issues and drafting proposed legislation.