Practice Area Overview
Drugs, Biologics, Vaccines, and Controlled SubstancesBringing a drug or vaccine to market is a complex process. At Olsson Frank Weeda, our attorneys provide comprehensive counseling and advocacy on Food and Drug Administration drug and biologic matters. We also represent clients on matters pertaining to controlled substances. Getting the Product to MarketIn our drug and biologic practice, we advise our clients on every aspect of the regulatory process related to bringing a product to market, including strategic planning, clinical investigations, bioequivalency testing, labeling, chemistry and manufacturing, and submitting the necessary applications. For close to 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 by helping them answer questions related to eligibility for the abbreviated application process, labeling, patent certifications, 180-day exclusivity provisions, and the scope of various non-patent exclusivity provisions. At Olsson Frank Weeda, 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. In addition to generic drugs, our practice covers a wide spectrum of drug and biologic products regulated by FDA, including innovator drug products and homeopathic drug products. In some cases, firms may be able to market products under an applicable over-the-counter (OTC) drug monograph, or as “old” drugs that are currently marketed, with FDA’s acquiescence, outside the current new drug pre-market approval process. We assist clients with approval requirements for biologic products that are licensed under the Public Health Service Act, including vaccines, blood products, and human tissue intended for transplant. Our attorneys have extensive experience serving clients involved with the manufacture and distribution of drugs that are also 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. We have advised companies and venture capital firms regarding regulatory environments surrounding drugs of concern, and have counseled companies concerning due diligence in the financing and acquisition of DEA-regulated entities. Marketing and DistributionOur 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 Olsson Frank Weeda, our attorneys are especially knowledgeable about the pharmaceutical distribution chain. Our practice includes providing legal advice on distribution of drug products, including controlled substances and biologics, drug importation and re-importation, pedigrees, the secondary market, repackaging, and combating counterfeiting. We advise clients on issues involving the marketing and promotion of drug products, including sales representative conduct and practices, patient registries, institutional promotion, promotion directed to consumers, and pharmacy-based communications. In addition, we provide counsel regarding federal medical privacy requirements, anti-kickback requirements, and Federal Trade Commission regulations. 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. 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. Focus on Human Cell and Tissue-Based ProductsIn addition to our traditional drugs and biologics practice, we have expertise in FDA’s new and emerging regulatory scheme for human cells, tissues, and cellular and tissue-based products (HCT/P). We advise clients on the establishment registration, product listing, donor screening and testing, and other “good tissue practices” requirements for HCT/Ps in FDA regulations. 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 assist in drafting FDA-related disclosures and statements for securities filings for HCT/P firms, and can provide litigation support involving HCT/P issues. Focus on Due Diligence SupportOur attorneys are an important resource for other law firms, investment bankers, venture capitalists, accountants, and other professionals engaged in matters requiring expertise in FDA drug and biologic 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 and biologics firms. Focus on AssociationsFor many years, we have served as counsel to trade associations whose members are regulated by FDA, USDA, and other agencies. We provide a full range of services to our trade association clients and their member companies, including:
Drugs, Biologics and Vaccine Attorneys: |
