Our FDA practice, focusing on food, drug, device, cosmetic, and tobacco regulatory and compliance matters, is an experienced and integrated team with a proven track record in all areas regulated by the Food and Drug Administration. We help clients navigate the regulatory process throughout the life cycle of their products—from planning and development, to approval and marketing, to enforcement and ongoing compliance.
In addition to addressing regulatory issues after companies have funding and patents in hand, we assist with regulatory due diligence and other transactional needs. Our clients include domestic and international manufacturers and distributors of food, dietary supplement, pharmaceutical, biological, medical device, tobacco, personal care and cosmetic products, as well as individuals and institutions involved in preclinical and clinical research of FDA-regulated products.
We offer clients multidisciplinary, global, regulatory, and transactional advice to help address FDA, Federal Trade Commission (FTC), Environmental Protection Agency, Consumer Product Safety Commission, Drug Enforcement Administration (DEA), and other agency hurdles. We have excellent working relationships across the government agencies that regulate life science companies.
We Understand the Science
In addition to our significant legal and regulatory experience, our FDA team has the scientific education and background to understand our clients’ issues. As the scientific landscape continues to evolve, we have the knowledge necessary to assist clients with the regulatory challenges affecting new drugs, monograph drugs, generic drugs, alternative medicines and therapies, tobacco products, medical devices, radiological products, food, nutraceuticals, dietary supplements, medical food, cosmetics and other personal care and “combination” products.
Our Global Platform
Our global platform allows our FDA team to offer domestic, international, and multinational companies 24/7 availability and a unique position from which to advise on research, approval, registration, import, export, and recall matters involving FDA-related issues to clients throughout Canada, the European Union, Japan and the Pacific Rim, Latin America, and other markets.
Drugs and Biologics
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 Investigational New Drug Application (IND), New Drug Application (NDA), Abbreviated New Drug Application, New Animal Drug Application (NADA), Abbreviated New Animal Drug Application, Biologic License Application, 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, current Good Manufacturing Practices, and inspectional issues, and we help clients respond to enforcement issues and numerous other regulatory matters before FDA, 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 Drug Efficacy Study Implementation 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.
Pharmaceutical Government Pricing
Lawyers in our FDA practice advise pharmaceutical manufacturers on all aspects of drug pricing, including obligations under the Medicaid Drug Rebate Program, the Medicare average sales price reporting requirement, VA Federal Ceiling Price, and the 340B Drug Pricing Program. We counsel clients on the government pricing implications of group purchasing organization (GPO), managed care, specialty pharmacy, and wholesaler arrangements, as well as patient assistance programs. We also represent our clients on managed care and public payor contracting matters, including pharmacy benefit manager, GPO, and wholesaler contract reviews and negotiations.
Medical Devices, In Vitro Diagnostics, and Biotechnology
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), Premarket Approval Applications, Investigational Device Exemptions (IDEs), product development plans, clinical research, labeling and promotional activities, competitor strategy and 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 standard operating procedures, 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 Securities and Exchange Commission; draft supplier, manufacturer, and distributor agreements; prepare clinical research agreements; and conduct in-house regulatory and executive training sessions.
Food and Dietary Supplements
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 assists our clients in addressing the issues and problems that arise for manufacturers, technology providers, and other interests in both the human and animal food areas. 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 good manufacturing practices; representation in enforcement proceedings; and a comprehensive range of other services for the food sector.
Cosmetics and Personal Care
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 and 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 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, facility inspections, 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, and reporting requirements under California’s Safe Cosmetic Act.
Our practice closely follows the FDA’s expanded authority over the manufacturing, distribution, and marketing of both combustible and non-combustible 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 electronic nicotine delivery device tobacco products. We have prepared and submitted Substantial Equivalence reports, challenges to Not Substantially Equivalent orders, advised clients on the necessary components of Premarket Tobacco Applications, as well as tobacco product labeling issues. Our lawyers work closely with our client’s scientific experts to develop the data necessary for FDA approval. In doing so, we frequently prepare agreements with non-clinical and clinical testing facilities and summarize study data in a manner that best addresses the regulatory requirements.
Combination Products and Product Jurisdiction
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 and 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.
Advertising and Promotion
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 experience defending against FDA, FTC, and industry enforcement, including National Advertising Division inquiries, FTC investigations, and consumer actions. We also counsel clients on FDA, FTC, Office of Prescription Drug Promotion, and Health and Human Services Office of the Inspector General enforcement trends and conduct compliance reviews of promotional copy, labeling, and launch materials.
HIPAA and Clinical Research
Our FDA lawyers advise clients on all aspects of preclinical and clinical research. We also provide integrated advice on compliance with all regulatory requirements for clinical and non-clinical studies including human subject protection standards, FDA’s IND and IDE regulations, Good Laboratory Practices and Good Clinical Practices requirements, clinical trial billing and reimbursement, HIPAA, tissue repositories, stem cell research, financial conflicts of interest, research misconduct, and response to FDA’s Bioresearch Monitoring Program 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, institutional review boards, and investigators.
Enforcement and Inspections
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.