Why is there an "FDA" today? Reviewing the evolution of food and drug law legislation and events reveals the answer. The mission of the United States Food and Drug Administration (FDA), a federal agency within the United States Department of Health and Human Services, is that of public protection which is in keeping with the evolution of food and drug related laws. FDA protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, medical devices, food, cosmetics, dietary supplements, electronic radiating products and for regulating tobacco products. Book I centers on significant legislation and legal decisions in food and drug law including United States Supreme Court cases that have impacted on the practice of food and drug law.
Chapter 1 details significant legislative enactments originating from the early English influence. Chapter 2 details landmark legislation and court decisions starting with 2000. For example, the decision of Washington Legal Foundation (WLF) v. Henney, decided in 2000 and Thompson v. Western States decided in 2002, invalidated portions of the Food and Drug Administration Modernization Act (FDAMA). The Bioterrorism Act of 2002 provided FDA with increased regulatory authority to safeguard the food and drug supply. Also, in 2002, specific legislation that focuses on the use of pediatric pharmaceuticals was enacted. User fees continue in the pharmaceutical arena and have been extended to the medical device industry with the enactment of the Medical Device User Fee and Modernization Act (MDUFMA) of 2002. The Medicare Modernization Act of 2003 and its application to patent issues and generic drug products has had a far-reaching impact in terms of patent reforms and more expedient entry of generic drug products into the marketplace. Known as the Best Pharmaceuticals for Children Act, this is a safety-based law about drugs for children. The 2003 Pediatric Research Equity Act was approved to complement and comport with the Best Pharmaceuticals for Children Act by explicit authorization for FDA to require pharmaceutical manufacturers to conduct pediatric clinical trials and studies. This chapter contains significant highlights of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Notable United States Supreme Court decisions pertaining to the duty of a drug manufacturer to warn included Wyeth v. Levine and Pliva v. Mensing with the result dependent on whether the pharmaceutical was a generic or brand name drug. Nearly ten years after the Brown v. Williamson Tobacco Supreme Court decision, Congress enacted the historic Family Smoking Prevention and Tobacco Control Act. The 2011 Food Safety Modernization Act, the 2012 FDA Safety and Innovation Act, 2013 Drug Quality and Security Act 2014 Sunscreen Innovation Act, the CURES Act of 2015, 2018 Right-to-Try Act, ongoing Opioid legislation, Tobacco Minimum Age Requirement and the COVID-19 CARES Act are highlighted.
Chapter 3 details the "why" of FDA. Finally, Chapter 4 focuses on the United States Food and Drug Administration (FDA) and other noteworthy agencies. The mission of FDA, as stated, in accordance with the Federal Food, Drug and Cosmetic Act (FDCA), is to protect the public health and safety. Each chapter contains critical analysis issues to explore.
