Our attorneys provide solutions to a variety of clients operating in heavily regulated industries. Whether the project entails helping a start-up company obtain marketing approval from the U.S. Food and Drug Administration (FDA) for an innovative product or technology; representing corporations in U.S. Department of Justice investigations; counseling food, drug, device and cosmetic companies on compliance with FDA and U.S. Department of Agriculture (USDA) inspection, safety and labeling requirements; or assisting regulated entities in corporate and commercial transactions, our attorneys use their experience, understanding of complex legal requirements, knowledge of the industries in which our clients operate, and our working relationships with relevant government regulators to develop affective solutions to our clients' needs.
Our clients include large pharmaceutical and biotechnology companies, smaller innovative organizations, and entrepreneurs, as well as entities that work with these companies, such as clinical research organizations (CRO), drug development companies and pharmacy benefit managers. We advise on products ranging from traditional prescription drugs, including controlled substances, over-the-counter medications and investigational new drugs. Our experience with and knowledge of government standards and practices, as well as our industry knowledge affords our clients substantial resources for their product development, approval and marketing needs.
When a client considers purchasing a product or business from another company, we perform due diligence investigations of regulatory issues and risk factors, as well as other legal and strategy issues. In the past, our attorneys have conducted due diligence projects on behalf of manufacturers, investment banks, private equity and venture capital firms, as well as individual investors. In particular, we utilize our experience and knowledge of the FDA and FTC regulatory process for drugs to perform risk assessments on regulatory processes affecting product approval, evaluate commercialization and post-approval activities, assess litigation risk in product liability actions, and provide input on the regulatory issues presented in financial disclosures and other transaction documents.
We also assist clients with their general corporate transactional needs, and function as de facto general counsel for several clients. In this role, we draft, negotiate and review various commercial contracts upon which our clients rely to conduct their businesses, including licensing, marketing and promotion, supply and distribution, clinical trial, and managed care agreements.
Our pharmaceutical and biotechnology clients benefit from our substantial experience navigating the regulatory frameworks governing the industries in which they operate. We continuously monitor developments and enforcement initiatives in the labeling, advertising and promotional area, including decisions brought under federal and state false claims acts and the application of FDA requirements to the internet advertising and promotion. We also have counseled clients on various aspects of product promotion and labeling, including direct-to-consumer advertising, to ensure compliance with the FDA, FTC and DOJ requirements and regulations.
We counsel clients on FDA's current Good Manufacturing Practice (GMPs) requirements in connection with their development of standard operating procedures for their manufacturing processes, as well as on FDA's product distribution and sampling requirements governed by the Prescription Drug Marketing Act of 1987 (PDMA) and FDA’s multiple post-marketing reporting requirements, including safety and manufacturing problem reports
Finally, we provide guidance to pharmaceutical and biotechnology clients with respect to regulation by the Drug Enforcement Administration (DEA). Whether it is a manufacturer, pharmacy, distributor, physician or other health care facility, our clients rely on our experience with FDA and DEA requirements governing the safe marketing and distribution of pharmaceutical products and controlled substances. Our practice includes a number of the firm's health and litigation lawyers, who advise clients on coverage and reimbursement for drugs, biologics and human tissue products, as well as compliance with federal and state fraud and abuse laws such as the Medicare and Medicaid anti-kickback laws, false claims statutes, and state and federal privacy laws, including HIPAA.
FDA Enforcement and Related Litigation
We assist clients with various types of FDA enforcement actions, including FDA inspections, responses to FDA 483 Inspectional Observations, as well as untitled and warning letters. We represent drug and biotechnology product manufacturers in injunction and seizure actions, recalls and market withdrawals, criminal prosecutions, assessments of civil penalties, and other regulatory actions brought by the FDA, FTC and state authorities. We also provide assistance with the review, development and implementation of manufacturing policies, inspection policies and corporate compliance programs that take into account FDA requirements, including clinical Good Manufacturing Practices.
The Product Liability Practice Group within our litigation department represents pharmaceutical and medical device manufacturers in cases filed in various state and federal courts throughout the United States. Included in the group are individuals who are trained in medicine, nursing, pharmacy, x-ray technology, toxicology and engineering. With respect to pharmaceutical and device products, our litigators work on behalf of the manufacturers of such products as Bendectin, DES, Thalidomide, Accutane, Phentermine, Parlodel, Phenylpropanolamine, Oxycontin, Pyridostigmine Bromide, blood and blood products, bone screws, breast implants, food supplements, such as L-tryptophan and ephedra, neutraceuticals, orthopedic implants, over-the-counter cough, cold and sleep aid medications, pacemakers, pacemaker leads, silicone implant products, surgical gloves, tampons, and urethral stone retrieval devices.
We represent medical device clients drawing on our years of experience to assist them in devising practical solutions to meet their objectives. Our clients rely on us for issues, including obtaining FDA approval to market device products, complying with FDA's post-market requirements and defending FDA enforcement actions. Like our pharmaceutical clients, we also assist clients with FDA-related aspects of commercial contracting and acquisitions and divestitures. We work with our clients to provide corporate due diligence in connection with transactions, including determining a company or product’s state of FDA compliance, handling the transfer of 510(k) notices and PMA applications, and reviewing FDA-related provisions of transaction documentation.
Additionally, we provide counseling on FDA's post-marketing regulations to assist clients in understanding FDA's requirements for manufacturing medical devices, including advising on product recalls, market withdrawals, product seizures and injunctive actions, as well as reporting adverse events and responding on behalf of our clients in connection with FDA enforcement actions.