FDA AND THE GOVERNING HEALTHCARE INDUSTRY

FDA and the Governing Healthcare Industry

FDA and the Governing Healthcare Industry

The History Of The Agency

The Food and Drug Administration (FDA) is the government agency under is a government agency under the Ministry of Health and Human Services, which regulates drugs, medical devices, and biologics. This regulatory authority has begun in the early 1900â € ™ S with the Food and Drug Act 1906, which allows the FDA to regulate the drug only after the drug was placed on the market by pharmaceutical companies. (Michael 2005) Years later, after the fact, Elixir sulfanilamide incident, the Federal Food, drug and Cosmetic Act of 1938 was passed. The Act requires the production of the drug companies to notify the FDA before marketing the drug, so that the product can be checked for safety. After yet another crisis in the early 1960â € ™ S, in which thousands of birth defects were associated with a product that women use to alleviate morning sickness in the 1962 Harris-Kefauver Amendments were adopted. In 1962 laws were determined prior to the adoption of a market system in which the FDA was granted the right to approve products for marketing based on safety and efficacy. (Michael 2005)

Medical And Manufacturing Devices

FDA intends to issue regulations on good manufacturing practices, which will focus on practices that ensure the identity, purity, quality, strength, and composition of dietary supplements. Currently, the manufacturer is responsible for establishing its own manufacturing practice guidelines for enusre, that its products are safe and contain components that are listed on the label. (Thomas 2008)

The Source And Scope Of Its Authority

FDA mission is to protect public health by helping safe and effective achievement of the products on the market in a timely manner, and monitoring products for continued safety after they are used. (Philip 2003)

FDA regulates over $ 1 trillion worth of consumer goods, about 25% of consumer spending in the United States. This includes $ 466 billion in food sales, $ 275 billion for drugs, $ 60 billion in cosmetics and $ 18 billion in vitamin supplements. Much of the cost of goods imported into the United States, the FDA is responsible for one third of total imports.

Structure

FDA provided the following examples of acceptable structure / function claims: `` reduces stress and frustration ,''`` prevents platelet aggregation,''and `` improves absentmindedness.''The Agency also stated that, unless the context does not suggest treatment or prevention ...