Fda Role

The United States Food and Drug Administration

HCS/430

January 17, 2011

Judith Kaplan

The United States Food and Drug Administration

Regulatory agencies are an important part of the United States health care industry. Regulatory agencies are responsible for “setting and enforcing standards for specific industries” (“Regulatory agency,” 2009, para. 1), in this case the health care industry. Regulatory agencies were designed to operate with minimal legislative supervision; therefore these agencies have their own “executive, legislative, and judicial functions; and their regulations have the force of law” (“Regulatory agency,” 2009, para. 1). The Food and Drug Administration (FDA) is one of the most important regulatory agencies. The FDA is an interdepartmental agency of the Department of Health and Human Services. Among other enforcements the FDA implements the sales and distribution of prescription and over the counter drugs (Fremgen, 2009).

The purpose of this paper is to describe the history of the FDA as well as the source and scope of its authority, its structure, how it carries out its day-to-day responsibilities, and its effects on the health care industry. Additionally, an example of the FDA carrying out its duties will be provided.

FDA History

“The FDA sets safety standards for food and cosmetics, and it monitors the safety and effectiveness of drugs, medical-devices, and radiation-emitting products” (Sullivan, 2002, p. 79). Although it was not yet known as the FDA, its origin can be traced back to 1862 when Lewis Caleb Beck was appointed into the Patent office (United States Food and Drug Administration, 2010). Beck carried out the chemical analysis of agricultural products, which in 1862 became a function of the Department of Agriculture when it was developed (United States Food and Drug Administration, 2010).

The FDA was named so in 1930; however, according to the FDA (2010) website its “regulatory functions began with the passage of...