LOJAH offers counseling and FDA representation services relating to the development, approval, exclusivity and marketing of new and generic drug products, medical devices, biologics, diagnostics, and foods. By coupling knowledge of the complex and shifting FDA, State and international regulatory landscapes with my scientific capability and patent licensing expertise, I can offer a comprehensive perspective to assist companies in developing product life cycle development strategies, bringing regulated products to market, defending market positions such as through exclusivity periods, and petitioning the federal government in an efficient, competitive and profitable manner.
R&D and FDA Product Approval: The development, manufacturing, and marketing of a food, drug or medical device requires an in-depth understanding of the FDA regulatory process, as well as the ability to interact effectively with FDA personnel. I have worked closely with clients from the earliest stage of a product’s life cycle – research and development. My work representing academic medical centers and universities, in addition to start-ups and global medical device and life sciences companies, gives me a broad perspective. I can offer counsel and advocacy regarding determinations relating to the necessity of and requirements relating to premarket clearance and approval filings. I can also advise with regard to sponsored research relationships with contract research organizations, clinical investigators and Institutional Review Boards, as well as with respect to compliance with federal laws governing clinical research, including exemption requirements, human subjects protections, adverse event reporting, clinical trial registration and results reporting.
Post-market Regulatory Compliance: I also offer counsel with respect to post-market requirements, enforcement and compliance issues, customs/import compliance, labeling (foods, drugs and devices), and product promotion and advertising issues. My dozen years with the FDA, and related work since including preventative self-evaluative Good Manufacturing Practices/Quality Systems Regulation audits, designing compliance and corrective action plans, training internal company audiences on compliance matters, and mitigating exposure, has made me well-qualified to assist you in responding to inspectional findings (i.e., 483's) and enforcement actions (e.g., Warning Letters), and managing crises such as major safety issues and recalls. It has also informed my ability to provide counsel with respect to complementary and/or overlapping rules and regulations of the Federal Trade Commission, Environmental Protection Agency, National Marine Fisheries Service, Consumer Product Safety Commission, state attorneys general, and other federal, state and international agencies.
Regulatory Exclusivity: Strategic business and legal advice is essential on statutory provisions that confer exclusive marketing rights on qualifying products, including the Hatch-Waxman Act, the Orphan Drug Act, the pediatric exclusivity provisions of the Federal Food, Drug & Cosmetic Act, and the Biologics Price Competition and Innovation Act. I write a monthly update on current cases and issues relating to regulatory exclusivity for the American Intellectual Property Law Association’s FDA Flash! newsletter and blog, through which I’ve gained a shareable thorough understanding of the strategic relationship between patent and non-patent exclusivity rights.