Food, Drugs, Medical Devices and Cosmetics (FDA)

We provide strategic direction on research and development and market entry pathways for clients seeking to enter the drug and biologics market. We assist with the IND, NDA, ANDA, NADA, ANADA, BLA, and Biosimilar approval and orphan designation processes. The value we provide to our clients does not stop when the FDA issues an approval letter. We also work with our clients to maintain compliance with FDA post-approval requirements, including labeling, advertising, cGMPs, and inspectional issues, and we help clients respond to enforcement issues and numerous other regulatory matters before FDA, Drug Enforcement Agency (DEA), FTC, and state agencies. Our lawyers understand our clients’ businesses and often play a major role in strategic decisions concerning life-cycle management, Hatch-Waxman (paragraph IV) patent challenges or defenses, and related competitive marketing activities.

We also advise on the medical therapies that do not require FDA preapproval, such as products subject to over-the-counter monographs, the DESI program, homeopathic rules, and grandfather statutes. We counsel clients on the risks, limitations, and legal boundaries for marketing claims for such products. Our lawyers also handle regulatory due diligence investigations and review contractual language for joint venture, investment banker, and venture capitalist transactions.

We advise established and emerging companies engaged in developing, manufacturing, and marketing medical devices, in vitro diagnostics, medical equipment, eHealth/mHealth/medical software, combination products, and biotechnology. We counsel on issues throughout the product life cycle, including market entry strategies, premarket submissions (510(k)s, PMAs, IDEs), product development plans, clinical research, labeling and promotional activities, competitor strategy/trade complaints, adverse event reporting, recalls, and enforcement defense.

We provide customized strategic advice for FDA-regulated devices positioned at the cutting edge of science, regulation, and public health policy. This includes conducting compliance audits, drafting regulatory SOPs, advising investors and underwriters, and developing regulatory strategy for clients in most therapeutic areas including clinical chemistry and clinical toxicology, cardiovascular, general hospital, radiology, physical medicine, and neurological devices. Our device practice also includes a strong transactional focus. We conduct FDA regulatory due diligence investigations; assist with the preparation of reports and disclosures to the SEC; draft supplier, manufacturer, and distributor agreements; prepare clinical research agreements; and conduct in-house regulatory and executive training sessions.

Consumers insist upon effective food safety regulation. Businesses seek clarity and predictability. The process is increasingly complicated by the industry’s global scope. Our FDA team has decades of experience, in effectively addressing the issues and problems that arise for growers, manufacturers, associations, cooperatives, technology providers, and other interests in this area. We provide crisis management in recall situations; counsel on ingredient, labeling, and advertising matters; regulatory strategies for conventional food, functional food, dietary supplements, and medical food; compliance with dietary supplement GMPs; representation in enforcement proceedings; and a comprehensive range of other services for the food sector.

Our food practice also helps prepare Generally Recognized As Safe (GRAS) and food contact notifications, GRAS self-affirmations and safety evaluations, and new dietary ingredient notifications for dietary supplements. In the inspection area, we have extensive experience on issues involving the application of cGMPs, HACCP, and other compliance mechanisms to FDA-regulated products.

Our EU regulatory food practice offers strategic legal advice to a broad array of clients in the food and drink industry. We have experience in a wide variety of areas including EU regulatory law and policy (free movement of goods, customs classifications, quotas), food labeling and advertising issues (health and nutrition claims, geographical indications and designations of origin), product registration (novel foods, food supplements, food for special medical purposes, cosmetics, etc.), and product liability (withdrawals, recalls), among others, with particular focus on innovative foods and drinks.

For clients that are seeking to expand their products into the EU, we help to navigate them through all aspects of the EU regulatory process. With more than 1,500 nutritional supplements and functional foods registered in the EU countries during the last eight years, we provide global clients with legal advice, creative solutions, and specific strategies for products being imported or marketed into the EU.

Technology advances often blur the cosmetic/drug/device distinction and have fostered a reevaluation of cosmetic safety and intended purposes. Our lawyers routinely advise companies on the critical definitional distinctions between cosmetics or personal care products and drugs/medical devices. We also assist clients in crafting labeling claims that comply with FDA and FTC requirements, including scientific substantiation and safety. Our lawyers are attuned to company and user concerns and to the innovation that is key to the industry. We counsel manufacturers, retailers, marketers, importers, exporters, and formulators on these and other issues such as “organic” claims, testing and claim support, inspections, import detentions, and product recalls. We also help clients identify and meet related state, federal, and international requirements, such as limits for volatile organic chemicals, labeling under California’s Proposition 65, reporting requirements under California’s Safe Cosmetic Act, and the EU’s REACH requirements.

Our FDA practice closely follows the FDA’s expanded authority over the manufacturing, distribution, and marketing of tobacco products. Our lawyers have extensive knowledge of all aspects of tobacco regulation, and advise clients with regard to labeling, substantial equivalence submissions, listings and registration, and dissolvable tobacco products. We also follow the deliberations of the FDA’s Tobacco Product Scientific Advisory Committee closely and advise industry and investors on jurisdictional and policy matters.

With the rapid advancement of materials science as well as biotechnology and pharmacology, the classification of a product as a drug, device, biological product, or combination of these product categories is becoming a significant issue in relation to marketing approval/clearance as well as market strategy for regulated industry. Our lawyers counsel clients on product category placement strategy, including whether a product is subject to the FDA’s jurisdiction. We also help frame issues related to how a product achieves its primary mode of action and prepare formal requests for designation.

Industry has become increasingly creative and competitive in its labeling, advertising, and promotional activities related to FDA-regulated products, which has resulted in intensified FDA and FTC scrutiny. To assist clients in navigating this often confusing and treacherous area, we advise on acceptable promotional claims and claim substantiation for all product types in all promotional venues, from traditional print ads to new social media spaces. We have extensive and successful experience defending against FDA, FTC, and industry enforcement, including NAD inquiries, FTC investigations, and consumer actions. We also counsel clients on FDA, FTC, DDMAC, and Health and Human Services Office of the Inspector General enforcement trends and conduct compliance reviews of promotional copy, labeling, and launch materials.

Our FDA lawyers advise clients on all aspects of preclinical and clinical research. We also provide integrated advice on compliance with human subject protection regulations, IND/IDE and GLP/GCP requirements, clinical trial billing and reimbursement, HIPAA, tissue repositories, stem cell research, financial conflicts of interest, research misconduct, and response to BIMO inspections. Additionally, we assist clients on transactional matters, including drafting and negotiating research agreements with U.S. and international sites, and government grants and contracts. Our client base is diverse and includes industry, academic medical centers, research hospitals, nonprofit research organizations, IRBs, and investigators.

Enforcement issues are at the core of any regulatory practice. This is particularly true within the FDA-regulated community with the agency’s publicly stated intent to leverage its resources through more aggressive use of the wide range of enforcement tools at its disposal. Our FDA team has extensive, successful experience representing product manufacturers, distributors, and marketers in matters ranging from informal compliance issues and negotiations with agency staff to investigations, formal administrative proceedings, and litigation in state and federal courts. More importantly, our ongoing counseling activities are geared toward the identification and mitigation of potential enforcement issues before they occur.