The legal framework in which manufacturers, processors and distributors of regulated products exist is undergoing a dramatic change.  As the scientific landscape continues to evolve, a host of novel regulatory challenges and product classification issues remain unsettled.  In this changing environment, consumer product, biomedical, and life science firms need capable advice on the interrelated regulatory, economic, financial, technical, intellectual property, and marketing issues they face.

The K&L Gates Food, Drug, Medical Device, and Cosmetic Practice (“Food & Drug Practice”) offers comprehensive legal and regulatory counseling to companies and other organizations regulated by the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). The Food & Drug Practice represents domestic and international manufacturers and distributors of food, dietary supplement, pharmaceutical, biological, probiotic, medical device, personal care and cosmetic products, as well as trade associations, individuals, and institutions involved in preclinical and clinical research of FDA and USDA-regulated products.

K&L Gates' Food & Drug Practice draws on the group’s legal and regulatory experience, as well as its background knowledge of the science that is an integral part of the practice. Most of our Food & Drug lawyers have degrees in areas such as pharmacy, biology, nursing, microbiology, neuroscience, engineering, and pharmacology, or previously have served in related government or industry positions. When coordination is required, the Food & Drug Practice lawyers interface with the firm’s corporate, life science, public policy, and litigation practices for efficient and cost-effective counseling and resolution.

The following briefly highlights some of the areas where the Food & Drug Practice has successfully advised clients regulated by FDA and USDA, as well as some of the projects where the Practice has provided specialized experience to the firm’s corporate, life science, and litigation lawyers.

Food /Dietary Supplements/Probiotics/Nutraceuticals

• Novel food and color additive petitions
  
  
• GRAS and food contact notifications
  
  
• GRAS self-affirmation and safety evaluations
  
  
• New dietary ingredient notifications for dietary supplements
  
  
• Product claims in labeling, advertising, and other promotional material, including clinical research and substantiation issues
  
  
• “Structure/function” claims notifications
  
  
• Regulatory strategies for functional food and dietary supplements
  
  
• Formulation, labeling and claims for functional food, dietary supplements, medical foods
  
  
• Recall and market withdrawal strategies 
  
  
• Food safety compliance related to HACCP, food security measures under the BioTerrorism Act, and relevant GMPs
  
  
• Dietary supplement GMP requirements
  
  
• FSIS Inspections of meat and produce establishments
  
  
• USDA and FDA Advisory Committee meetings and hearings
  
  
• Administrative hearings and rulemaking proceedings
  
  
• Import detentions, seizures and alleged food tampering

Drugs and Biologics

• Regulatory strategies for human drug (i.e., NDA, ANDA, OTC, and homeopathic), animal drug, and biotechnology-derived products
  
  
• Pre-clinical and clinical regulatory support, including Good Laboratory Practice (GLP), Good Clinical Practice (“GCP”), and financial disclosures
  
  
• Oversight and coordination of clinical research with Institutional Review Boards (IRBs) and Contract Research Organizations (CROs)
  
  
• Preparation of Investigational New Drug (IND) and new drug submissions for human and animal use (traditional New Drug Applications (NDA), 505(b)(2), and Abbreviated New Drug Applications (ANDA))
  
  
• Cell and tissue-based product compliance and issues related to research, acquisition, import, and export
  
  
• Treatment INDs and emergency use of unapproved products
  
  
• Drug labeling and advertising, including off-label research and promotion of approved drugs
  
  
• OTC and homeopathic drug formulation, labeling, presentation and advertising
  
  
• Rx to OTC drug switches
  
  
• “Combination product” counseling and strategy
  
  
• cGMP Compliance, including SOPs, records, reporting, laboratory compliance 
  
  
• Adverse event reporting
  
  
• Citizen petitions and other materials for submission to FDA, including OTC drug review and market exclusivity material
  
  
• Congressional and state legislative initiatives

Medical Devices

• Pre-clinical and clinical regulatory issues
  
  
• Investigational device (IDE)  counseling and preparation
  
  
• New product approval (PMA) strategy and submissions
  
  
• Product clearance (510(k)) submissions, including classification advice and strategy
  
  
• Off label research and promotion issues
  
  
• Regulatory strategies and corporate policies including development of regulatory SOPs
  
  
• “Combination product” counseling and strategy
  
  
• Recall, market withdrawal, and corrective action assistance
  
  
• Quality System and GMP Compliance
  
  
• Inspection preparation and follow-up
  
  
• Radiation Control for Health and Safety Act compliance
  
  
• Reimbursement of investigational products
  
  
• Adverse event reporting
  
  
• Import detentions and seizures

Cosmetics And Personal Care Products

• Ingredient and formulation assessment
  
  
• Advertising and labeling review
  
  
• Claims support counseling
  
  
• Combination OTC drug/cosmetic counseling and regulatory strategy
  
  
• Certificates of Free Sale
  
  
• Recall and market withdrawal strategies

Representation Before Government Agencies And Enforcement Response
An integral part of K&L Gates’ Food & Drug Practice includes representing clients before the FDA, USDA and agencies with jurisdiction over related matters, such as the Drug Enforcement Agency (DEA), the Federal Trade Commission (FTC), the Environmental Protection Agency (EPA), the Consumer Product Safety Commission (CPSC), and the Alcohol, Tobacco Tax and Trade Bureau (TTB).  Examples of such representation include:

• RFDA and FSIS inspection preparation and response
  
  
• Response to formal enforcement actions such as Warning Letters, Notice of Violation Letters, Civil Penalty actions, seizures, injunctions, detentions, and debarment proceedings
  
  
• Participating in administrative hearings and rulemaking proceedings
  
  
• Participating and reporting on Advisory Panel meetings and hearings
  
  
• Responding to criminal and civil charges related to FDA and USDA violations (e.g., products, claims, facilities, corporate personnel, clinical investigators and study sponsors)
  Responding to public health emergencies (e.g., mad cow  disease, avian flu and food-source poisoning)

Life Science Practice Interface
As part of the firm’s inter-office and interdisciplinary Life Sciences Practice, K&L Gates’ Food & Drug lawyers counsel emerging technology firms who are on the leading edge of genomic, biotechnical, and medical device innovation.  In addition to extensive experience in the corporate, regulatory and legislative aspects of food, drug and device law, K&L Gates Food & Drug lawyers have a broad range of scientific and technical backgrounds. This experience allows our lawyers to provide assistance in all stages of the product lifecycle, including: development, approval, marketing, enforcement and ongoing compliance.

As part of K&L Gates’ commitment to monitoring and advising on cutting-edge issues, our Food & Drug lawyers are an integral part of the firm’s Stem Cell Technology Practice. This practice combines the knowledge and experience of lawyers from diverse areas of the firm to respond to legal issues unique to stem cell technology, including its development and commercialization. Current stem-cell related legal work focuses on research funding, intellectual property protection, insurance coverage and regulatory compliance in pre-clinical and clinical research.

Coupled with the firm’s extensive capabilities in intellectual property, health care, litigation, transactional and corporate finance, K&L Gates’ Food & Drug Practice offers clients extraordinary depth and breadth of service.

Litigation Practice Interface
The Food & Drug Practice, in conjuction with the firm's litigation lawyers, represents clients in civil and criminal actions involving compliance with various FDA and USDA requirements as well as suits challenging FDA regulatory actions and product liability cases. 

We have represented clients before the U.S. Department of Justice (DOJ), the Drug Enforcement Agency (DEA), the Federal Trade Commission (FTC), the Environmental Protection Agency (EPA), Alcohol and Tobacco Tax and Trade Bureau (TTB), the Consumer Product Safety Commission (CPSC), the U.S. Customs & Border Protection (C&BP), the US Patent and Trademark Office (USPTO) and related state agencies when approval, labeling, advertising, formulations, importation, or exportation of products falls within the jurisdiction of those agencies. 
These include:

• Seizure and injunction actions
  
  
• Coordinating FDA submissions (e.g., ANDA and device submissions) with patent strategies and litigation
  
  
• Advertising defense before the Federal Trade Commission (FTC), the Better Business Bureaus’ National Advertising Division (NAD), and State Lawyers General
  
  
• Competitor challenges under Federal and State laws
  
  
• Coordinated counseling and defense in product liability litigation

Corporate Practice Interface
In working with clients of all sizes along the distribution chain to develop new business opportunities and short- and long-term regulatory strategies, our lawyers provide consultation on various aspects of business transactions involving R&D, operations, products, and facilities regulated by the FDA, USDA, DEA, EPA, FTC, and TTB.  These include:

• Fraud, regulatory, and due diligence investigations for public financing,  acquisition, or sale of firms regulated by FDA and USDA
  
  
• Conflict of interest issues
  
  
• Coordinated drafting and review of domestic and international contracts and agreements related to FDA and USDA product development, materials acquisition, research, manufacture, distribution and marketing
  
  
• Document preparation for acquisition or sale of FDA or USDA regulated business units
  
  
• Preparation of Requests for Proposal (RFPs) for government contracts, targeting BioShield funding opportunities, drafting purchasing agreements, and subcontracts for pre-clinical and clinical research that comply with FAR and other requirements
  
  
• Legislative monitoring and advocacy at the Federal and State level in response to client concerns

International Practice Interface
Because many of our clients are multinational, we provide counsel on research, approval, registration, import, export, and recall matters involving FDA and Customs issues throughout Canada, the European Union, Japan and the Pacific Rim, Latin America, and other markets.  Together with lawyers from our other offices, K&L Gates’ Food & Drug lawyers offer experienced depth and breadth to our international clients.

Public Policy Interface
In cooperation with our colleagues in K&L Gates’ Public Policy and Law practice, our Food & Drug lawyers advocate on behalf of our clients before regulatory agencies and in the legislative arena. In addition to the Food & Drug lawyers who have prior government experience in the FDA and USDA, K&L Gates’ Public Policy and Law team has lawyers and professional consultants with extensive legislative, administrative and political experience at all levels of the U.S. federal, state and local governments.  More information on K&L Gates’ public policy capabilities can be found on our Public Policy and Law practice page.