ABSTRACT
The Food and Drug Administration (FDA) in the United States is currently responsible for regulations and enforcement actions for food, drugs, medical devices, radiation-emitting products, vaccines, blood and biologics, animal and veterinary medicine equivalents, cosmetics, and recently, tobacco products. Chapter 16 covered the FDA’s responsibility primarily in the area of medical devices such as a biomedical engineer might be responsible for designing and building and testing. This chapter will cover some of the relevant material, again for biomedical engineers, in terms of drug development and testing, veterinary drugs, cosmetics, and dual-use products-which are combinations of drugs and devices. We will begin the chapter with a bit of history in order to better justify the powers of the FDA and how they have evolved over the last 100+ years of existence.
The first pharmacopeia in U.S. literature was developed in 1820 (https://www.fda.gov/aboutfda/ whatwedo/history/milestones/ucm128305.htm). A pharmacopoeia is a formal listing of all recognized drugs in use at the time. It has been updated on a regular basis and remains the standard in terms of U.S. laws and regulations at the current time. The first major drug regulation was passed by Congress in 1848 and was termed the drug importation act. Its purpose was to stop the import of adulterated drugs from overseas. With the pharmacopeia in place, Congress had the definition as to what constituted a drug and the expected results of using that drug. At the time, and to a lesser extent now, adulteration of drugs was a problem. Adulteration is the act of cutting, for example, a drug, with a thinning agent such as alcohol in order to sell a larger quantity of the “original” material. Adulteration can also involve food supplies and, at the time, could, for example, involve the addition of coloring and other agents to mask the taste and odor of spoiled foods. Adulteration in foods can be safe, such as adding sugar water to honey or distilled water to whiskey, but it is not necessarily legal. It can also be unsafe. For example, lead “tastes” sweet and can and has been used as a sweetener and colorant. Food and drug adulteration were safety concerns throughout the 1800s.
