We help pharmaceutical and medical device manufacturers, energy companies, pesticide and chemical companies, and auto parts and consumer products makers manage risks associated with marketing and distribution. Collaborating with our clients, we craft claims avoidance strategies from the conception of a medicine or consumer product through its design, manufacturing and marketing. For pharma clients, our “molecule to market” advice covers informed consent documents and procedures, risk management and avoidance, and pre-trial and post-trial marketing studies. McCarter’s in-house team of scientists provides technical assistance.
Food and Drug Administration
We advise pharmaceutical companies with respect to their rigorous obligations before the FDA under the Food, Drug & Cosmetics Act and the accompanying regulations in Title 21 of the Code of Federal Regulations. Our team also advises manufacturers, distributors and importers with respect to the relevant regulatory requirements in connection with food, food additives and dietary supplements, including GRAS ratings and USP and NF requirements. The group offers strategic planning and risk management guidance regarding compliance with various federal regulatory entities including the FDA, EPA, USDA and FTC. We provide regulatory consulting services on legal and compliance issues during the development, marketing and distribution phases of our clients’ products. We also handle federal and state enforcement matters, whether it involves appearing before a regulatory tribunal or negotiating the resolution of a claim.
The clinical trial team advises life sciences clients on a wide range of complex issues during Phases I-IV of the FDA clinical trial process. We handle various transactions with clinical research organizations; private, public and government research institutions; and principal investigators. We draft and negotiate multiple agreements, including master service agreements, clinical trial agreements and patient informed consent forms for research sites in the U.S., Canada, Germany, Australia, Taiwan, Thailand, Indonesia, Malaysia and Vietnam. The group drafts independent data monitoring committee charters and member agreements. We also assist clients in responding to inquiries from the FDA and counsel on HIPAA and Medicare compliance issues.
Consumer Product Safety Commission
Our lawyers advise on Consumer Product Safety Commission (CPSC) regulations and requirements, including Section 15 and 37 reporting, and all aspects of national product recall campaigns. We constantly monitor CPSC developments, helping clients sidestep legal actions and develop warning labels, packaging, package inserts and material safety data sheets to communicate information on safe use and potential product hazards. The team assists with issues including:
We represent manufacturers, distributors and retailers of consumer products such as clothing, children's sleepwear, electrical appliances, swimming pool equipment, household appliances, glass products and candles, among many others.