Life Sciences - Regulatory
We provide a broad range of sophisticated regulatory and legislative services to food and agricultural clients who are regulated by the U.S. Department of Food and Drug (FDA), U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), U.S. Bureau of Alcohol, Tobacco and Firearms, U.S. Department of Commerce, U.S. Federal Trade Commission (FTC), Office of the United States Trade Representative, the International Trade Commission and their equivalent bodies in Europe, notably the European Commission and local government authorities. Examples of our work on behalf of life sciences clients include providing assistance in obtaining state and federal approval to field test and market new products, such as transgenic plants and food and feed, food enzymes, pest control products, animal biologics and drugs and transgenic animals.
We advise clients at all stages of the regulatory process, including consulting with respect to clinical trials and Institutional Review Board (IRB) procedures and investigations; preparing approvable marketing applications through the FDA and EMGA review processes; developing policies and procedures for testing, manufacturing, quality assurance, packaging and labeling; and obtaining and protecting favorable formulary status. In addition, we represent life sciences companies with ongoing FDA or equivalent EU based regulatory issues arising from plant inspections, “warning letters,” product modifications and changes to intended uses that may require supplemental marketing applications. We also advise pharmaceutical and medical device manufacturers concerning data selection, generation and accumulation to support marketing applications, promotional claims and reimbursement strategies.
Comprehensive assistance from product research and development through commercialization for pharmaceuticals, biologicals, medical devices, and in vitro diagnostics with Medicare, Medicaid and private payers, including:
- coverage—product dossiers to address coverage criteria, technology assessments, benefit category determinations
- payment—prospective payment systems, fee schedules, "Least Costly Alternative"
- coding—diagnosis codes (ICD-9-CM), procedure codes (CPT) and product coding (HCPCS)
- appeals—reconsiderations, fair hearings, administrative and judicial appeals
- health economics/outcomes research—payer value messaging, regulatory compliance
Our environmental, OSHA and real estate lawyers are familiar with the full array of local, national and international environmental regulations relating to the establishment and operation of life sciences businesses and facilities. Among other groundbreaking efforts, our lawyers handled the first field tests of GMO agricultural products and helped draft the interagency agreement allocating the regulatory responsibilities for biotechnology among the federal regulatory agencies. Our environmental and OSHA law practices are among the most prestigious in the United States and include scientific and engineering support staff to ensure the delivery of comprehensive and cost effective service.
McDermott has handled environmental issues in more than 50 countries and has continued to expand the scope of its services in emerging areas such as product rollout compliance reviews, brownfields redevelopment, hazardous material recycling, indoor air pollution and pollution prevention and process risk reduction. Our OSHA Group complements our environmental practice by providing a comprehensive service in the areas of process safety management and employee safety and in responding to catastrophic and accidental events. Because of the breadth of our environmental and OSHA litigation experience, we have the capability to manage and litigate the largest environment and OSHA cases should the need arise.
Members of our Health Law Department have served as prosecutors and regulators in U.S.-based state and federal agencies charged with health care enforcement and as compliance and privacy officers. We represent clients in audit inquiries and investigations by the FDA, FTC, National Institutes of Health, the U.S. Department of Justice, Office of the Inspector General of the U.S. Department of Health and Human Services, the Drug U.S. Enforcement Administration, state departments of public health, attorney generals, Medicaid fraud control units, professional regulatory and disciplinary boards and other government agencies. Our experience includes federal investigations regarding drug pricing, fraud and abuse and research misconduct. We also conduct compliance reviews for life sciences companies, academic medical centers, hospital IRBs, research institutes, health care providers, medical device manufacturers and prescription benefit managers and have defended qui tam False Claims Act cases and implemented and monitored corporate integrity agreements.
Advances in the life sciences field raise many issues of public policy and concern. At times, life sciences companies may find that a change in public policy is needed to address their business needs. For such companies, McDermott maintains a highly respected Legislative Group based in our Washington, D.C. office.
Our legislative practice professionals have served in policy positions in the U.S. Cabinet, federal House of Representatives, the U.S. Senate and in the Executive Branch. Others have worked in the U.S. Department of Health and Human Services, the FDA, the Institute for Medicine, the U.S. Department of Justice, the USDA, the Environmental Protection Agency, the U.S. Department of Commerce, the Federal Trade Commission, the Office of the U.S. Trade Representative, the International Trade Commission and the U.S. Bureau of Customs and Border Protection, among others. Our professionals were involved in negotiating the interagency memorandum with the FDA, Department of Agriculture and EPA regarding jurisdiction regarding biotech matters. We have also been involved in legislative work involving the Plant Variety Protection Act and in the current controversy regarding cloning and stem cell research.
Contacts
- Robert B. Nicholas
202.756.8170
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