Practice Area Overview
Drugs, Biologics, and Controlled SubstancesFrom Early Development to Marketed Products We advise our clients on every aspect of the regulatory process related to bringing a product to market, including: strategic planning and submission of dossiers for approval of New Drug Applications (NDAs), Investigational New Drug submissions (INDs), and Biologic License Applications (BLAs); clinical and nonclinical investigations; bioequivalency testing, labeling, chemistry, and manufacturing. Our drug practice is unique because we provide in-depth assistance beginning with the earliest development stages of drugs and biologics, continuing with the drafting and filing of approval applications for investigations, facilitation of final approvals of both innovator and generic drugs, and counsel regarding the post-approval regulation of marketing and manufacturing of the product. Generic Drugs/ANDAs and 505(b)(2) NDAs For over 20 years, we have advised clients on how to bring generic drugs to market under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. We aid clients in their approval and market entry strategies - including Abbreviated New Drug Applications (ANDAs), 505(b)(2) NDAs, and ANDA Suitability Petitions - by helping them answer questions related to eligibility for the abbreviated and 505(b)(2) application processes, labeling, patent certifications, 180-day exclusivity provisions, and the scope of various non-patent exclusivity provisions. Drug Exclusivity Litigation At OFW, our attorneys have handled more litigation involving FDA and generic drug approval requirements than any other law firm. When protection of market exclusivity becomes an attempt to "game" the system, we help clients submit trade complaints to regulatory authorities. Over-the-Counter Drugs We advise firms on marketing products under over-the-counter (OTC) tentative and final drug monographs, or as competitors to "old" drugs that are currently marketed. IND/NDA/BLA Process We assist clients with development, submission, and approval requirements related to the conduct of human clinical research for drugs and biologic products including new chemical entities, well-characterized proteins, and antibodies. Our attorneys also have extensive experience with the development, submission, and approval of NDAs and BLAs. We have represented clients seeking approval for initial human clinical studies through the review of their Current Good Manufacturing Practice (cGMP), nonclinical toxicology, pharmacology, and the proposed clinical development plan. We also have been intimately involved in reviewing and advising the data and dossier information for NDAs and BLAs, including reviews of manufacturing, toxicokinetics, pharmacodynamics, safety pharmacology, pharmacokinetics, clinical studies as well as the Electronic Common Technical Document (eCTD) backbone. We are experts in assisting our clients in navigating this multiyear process. Cellular and Stem Cell Therapy We have extensive experience in filing data related to cellular and stem cell therapy. Additionally, we have assisted in the initiation of some of the first clinical trials of human stem cells. Controlled Substances Our attorneys have comprehensive experience serving clients involved with the manufacture and distribution of drugs that also are designated controlled substances or listed chemicals. The approval of these drugs falls under a parallel regulatory scheme administered by the U.S. Drug Enforcement Administration (DEA) and the states. We have represented manufacturers, distributors, and DEA-registered clients in registration proceedings, inspections, and criminal investigations. On behalf of clients, we have been at the forefront of policy development to combat illicit methamphetamine manufacture. Drug Distribution Our representation of clients does not stop once a product is on the market. After drugs leave their place of manufacture, they enter a complex distribution chain. At OFW, our attorneys are especially knowledgeable about the pharmaceutical distribution chain. We provide a wide-variety of legal advice concerning the wholesale distribution of drug products, including: controlled substances and biologics; drug importation and re-importation; "pedigree" issues arising under the Prescription Drug Marketing Act of 1987 (PDMA) at the federal and state levels; additional state requirements; the secondary market; repackaging; and combating counterfeiting, diversion and other avenues by which drugs become unsaleable. Marketing and Promotion We advise clients on issues involving the marketing and promotion of drug products, including review of promotional materials, sales representative conduct and practices, patient registries, institutional promotion, promotion directed to consumers, and pharmacy-based and physician-based communications. In addition, we provide counsel regarding anti-kickback requirements and Federal Trade Commission (FTC) regulations. We also have been involved in the negotiation, development, and implementation of corporate compliance programs. Privacy of Personal Health Information We advise clients regarding the requirements for maintaining the privacy of personal health information, including the applicability of federal and state privacy requirements on pharmaceutical manufacturer-sponsored communications programs that are targeted at individuals based on their personal information. We can also help evaluate duties to maintain privacy, obtain waivers or agency agreements, and the interaction of medical privacy laws with FDA regulatory requirements - such as biomedical recordkeeping and FDA clinical inspections. Enforcement and Compliance We represent clients on the entire range of issues related to marketed products, including labeling, advertising, recordkeeping, reporting obligations, inspections, current good manufacturing practices, warning letters, and recalls. Our extensive experience enables us to act as effective intermediaries between regulators and the regulated industry during and after facilities inspections with regard to 483s and untitled and Warning Letters. Our breadth of knowledge helps us address the agency's concerns, and expeditiously resolve issues raised during FDA inspections. We represent our clients before federal agencies and, where necessary, before federal courts in connection with product seizures, injunctions, and criminal prosecutions. Human Cell and Tissue Products We have extensive knowledge of FDA's regulatory program for human cell and tissue products (HCT/P). We advise clients on the establishment registration, product listing, donor screening and testing, and current good tissue practices, labeling and reporting requirements for HCT/Ps. In addition, we advise on inspection matters and enforcement actions involving HCT/Ps. We also act as an important resource for clients engaged in business matters requiring expertise in FDA HCT/P regulation. For example, we assist with due diligence evaluations of FDA HCT/P compliance and provide advice on contractual language for mergers and acquisitions involving HCT/P firms and/or products. We also assist in drafting FDA-related disclosures and statements for securities filings for HCT/P firms, and can provide litigation support involving HCT/P issues. Investment and Due Diligence Support Our attorneys are an important resource for other law firms, investment bankers, venture capitalists, accountants, and companies seeking licensing investment, private placement or public offerings in matters requiring expertise in FDA drug, biological product, medical device and controlled substance law and regulation. Our attorneys are frequently retained to assist with due diligence evaluations of FDA-regulated companies and to provide advice on contractual language and representations and warranties for transactions involving drug, biologic, and controlled substance firms. We have advised companies and venture capital firms regarding regulatory environments surrounding drugs and biologics of concern, and have counseled companies concerning due diligence in the financing and acquisition of DEA-regulated entities. Focus on Associations For many years, we have served as counsel to trade associations whose members are regulated by FDA and other federal agencies. We provide a full range of services to our trade association clients and their member companies, including: • Advice to the association's executive committee, board of directors, committees, and staff; • Attendance at, and monitoring of, association meetings; • Assistance in drafting and filing government documents; • Counsel during periods of association transition, changes in leadership, and mergers; • Regulatory advice to association staff on applicable federal and state requirements; and • Legal support to the association's government affairs and legislative initiatives. Drugs, Biologics, and Controlled Substances Attorneys:
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