USA Law and Practice Contributed by: Daniel Kracov, David Marsh and Alice Ho, Arnold & Porter
Arnold & Porter 601 Massachusetts Ave NW Washington DC 20001-3743 USA
Tel: +1 202 942 5120 Fax: +1 202 942 5999 Email: daniel.kracov@arnoldporter.com Web: www.arnoldporter.com
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation The primary legislation governing the authorisation, marketing, sale and supply of pharmaceutical prod- ucts by the US Food and Drug Administration (FDA) is the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), which has been amended many times through- out the years to reflect increasing FDA mandates for the regulation of pharmaceutical products. The Pub- lic Health Service Act (the “PHS Act”) is the specific authority used to approve or license biological (includ- ing biosimilar) products, although human biological products meet the statutory drug definition and are regulated under the FD&C Act as well. Drugs and Biologics The primary FDA regulations governing drugs and bio- logics are found in Chapter 21 of the Code of Federal Regulations. Controlled substances, such as opioids, are also scheduled and subject to quotas and distri- bution controls under the Controlled Substances Act administered by the Drug Enforcement Administra- tion (DEA). Note that although the FDA regulates ani- mal drugs, animal biologics are regulated by the US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) under separate authori- ties. Under the FD&C Act, a drug is defined as: • an article recognised in the US Pharmacopoeia, the Homeopathic Pharmacopoeia of the United States or the National Formulary;
• an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease; • an article (other than food) intended to affect the structure or any function of the body; and • an article intended for use as a component of a drug but not as a device (or a component, part or accessory of a device). A biologic is defined under the PHS Act as “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component (or derivative), allergenic product, protein (or analogous product), or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound) applicable to the preven- tion, treatment or cure of a disease or condition of human beings”. Notably, a protein is any alpha ami- no acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. Biologi- cal products also fall within the drug definition and are generally covered by most of the same laws and regulations; however, differences exist in the regula- tory approach. Medical Devices Medical devices are also regulated by the FDA under the FD&C Act and – although subject to similar intent standards – such products primarily act via mechani- cal rather than chemical or biological modes of action. Medical devices are classified by risk and may be: • exempt from FDA review; • subject to a “510 (k)” pre-market notification process if they show substantial equivalence to a “predicate” device;
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