Pharmaceuticals & Biologics

We represent manufacturers and marketers of human and animal drugs, biologics, human tissue, and stem cell products on a broad spectrum of issues, including new product development and approval, monograph requirements for over the counter (OTC) products, counseling and advocacy for the approval of new and generic drug applications (including new drug applications (NDA), 505(b)(2) applications, and abbreviated new drug applications (ANDA), rules governing compounded drugs, and labeling and advertising issues for both Rx and OTC drugs.

Further, our attorneys counsel manufacturers of biological products on all aspects of compliance associated with the safety, purity, and potency requirements of the Public Health Service Act (PHS Act) and matters pertaining to biologics licensure. Polsinelli’s Food, Drug & Device team has significant experience navigating the intersection of the Federal Food, Drug, and Cosmetic Act (FFDCA) and the PHS Act concerning Human Cells, Tissues, and Cellular and Tissue-Based Products.

Polsinelli attorneys also represent litigants in actions brought against FDA. We handle FDA citizen petitions and litigate cases involving marketing exclusivities, patent listings, certification and notification requirements, bioequivalence, labeling, and other issues relevant to the FDA drug approval process. Our attorneys have been involved in pioneering cases before the FDA, including one the media has described as the first in which a court has ordered the FDA to approve a drug.

Food & Beverage, Agriculture & Dietary Supplements

We advise a diverse mix of clients, from single-product early-stage food companies to multinational food manufacturers and trade associations, coalitions, and nonprofit organizations. The core of our practice rests on decades of experience helping clients navigate the complex regulatory frameworks and policies of the FDA and the USDA, as well as those of counterpart agencies at the state and local level and, increasingly, foreign government and global regulatory bodies, including the European food and agriculture regulatory bodies and the numerous WHO entities. We have extensive experience with and can help companies comply with ingredient regulations, including regulations related to GRAS notices and food and color additive petitions. We advise clients on product formulation issues, nutrient and health-related claims, required and permissible label disclosures, claim analysis and substantiation, competitor challenges, and food safety compliance, including the numerous issues arising under the Food Safety Modernization Act.

Our attorneys counsel dietary supplement companies on a range of issues arising under the Dietary Supplement Health and Education Act (DSHEA), including product formulation, current Good Manufacturing Practice (“cGMP”) compliance, labeling, advertising, and promotion. We help our supplement clients evaluate the best approach for their dietary ingredients, including whether a new dietary ingredient notification is required. We have prepared and submitted successful new dietary ingredient submissions and structure/function claim notifications to the FDA.

Medical Devices & Diagnostics

Understanding the nuances of medical device manufacturing and distribution allows our attorneys to help clients navigate the FDA regulatory process. Polsinelli’s Food, Drug & Device attorneys provide counseling and advocacy on medical device matters, ranging from product clearance and approval strategies to post-market requirements, enforcement/compliance issues, and promotion and advertising issues. Our attorneys are experienced in working closely with clients to help evaluate proposed labeling and intended use claims with potential regulatory pathways to achieve clients’ business objectives. We also counsel clients on clinical trial design, IRB-related issues, and the scalability of Quality Management System requirements. Polsinelli’s Food, Drug and Device team has years of experience advising manufacturers of traditional medical devices of all risk classifications, digital health-based products, device-biologic combination products, and in vitro diagnostics.

Cosmetics

Members of the Food, Drug & Device team provide counsel on an array of general cosmetic product issues, including determining whether a product is a drug or a cosmetic. We assist our clients as they seek to determine what claims can be made for a product without making drug claims for the product and FDA and FTC claim criteria, labeling regulations and product safety data. We also work with clients facing challenges from state and local regulations that are often at odds with federal regulations. We advise clients on the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Advertising & Promotion

We routinely assist clients in developing marketing strategies based upon FDA product classification and substantiation criteria established by the FDA and FTC, and in court under the Lanham Act. We partner with clients and review claim substantiation materials to develop the most effective lawful marketing strategies. We help clients evaluate advertising and promotion by competitors, including developing innovative approaches to keep marketplaces honest.  We initiate and defend challenges to advertising and promotion practices involving competitors, consumers, and government regulators.

We advise our prescription drug clients on FDA advertising standards and practices for advertising and promotion opportunities. We assist clients in developing their labeling and advertising claims, often reviewing client substantiation dossiers to develop appropriate claims and defending claims before appropriate authorities.

Compliance & Enforcement

Inevitably, companies will encounter a compliance issue, regulatory enforcement, and/or a consumer or competitor challenge. We advise clients on complaint handling and compliance monitoring so that they can effectively and timely identify potential issues. We also assist clients in communicating with regulators about compliance issues and provide advice and assistance on conducting product recalls. When a client is the subject of regulatory enforcement action or receives communication about a threatened or actual challenge by a competitor or third party, we partner with that client to review and assess allegations, draft appropriate and effective written responses, and implement any necessary corrective action.

Consumer Products

Many of our clients also market products such as clothing, children’s toys, and exercise equipment that are regulated as “consumer products” by the CPSC. We assist these clients in understanding the unique product-specific regulatory standards that may apply to these products. We also advise and guide clients on the evaluation of product hazards, making required reports, and, when necessary, conducting CPSC-related product recalls.