Presentation Powerpoint for Senior Sem

Presentation Powerpoint for Senior Sem - Click to edit...

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Unformatted text preview: Click to edit Master subtitle style 7/7/11 The Ethics of Government Intervention In The Pharmaceutical World 7/7/11 Introduction For pharmaceutical companies, patients, and legislators, drug access and regulation have throughout history posed significant questions of business ethics. The MHS or Marine Hospital Service was created in 1798 to provide medical care for seamen and later became known as the Hygienic Laboratory, and finally as the U.S. Public Health Service (Cruz, Kathleen L.). In response to a number of deaths resulting from the manufacture and distribution of the drug elixir sulfonamide, Congress passed the Federal Food, Drug, and Cosmetic Act in 1938. In 1962, the act was amended to include more rigorous clinical testing through a series of phases mandated through pre- market approval of all new drugs (Salbu, Steven). These 7/7/11 Introduction In 1969 the FDA began administering the sanitation programs for milk, shellfish, food service, and interstate travel facilities, in order to prevent poisoning and accidents. The Food and Drug Administration Act of 1988 officially establishes FDA as an agency of the Department of Health and Human Services with a Commissioner of Food and Drugs appointed by the President. In 1994, FDA passed the Dietary Supplement Health and Education Act, which required companies to have specific labels and provided guidelines to regulate claims. One of the more recent and impacting bans the FDA placed on companies was the forbiddance to sell ephedrine based products or over- the-counter steroid precursors. The FDA is overall responsible for shielding the public health by 7/7/11 Introduction The majority of drug producers and pharmaceutical companies vie competitively for FDA approval and this agency has the unique responsibility to regulate and approve drugs in the United States. Over-the-counter and prescription drugs, including generic drugs, are regulated by a part of the FDA known as the Center for Drug Evaluation and Research (CDER). Fluoride, toothpaste, antiperspirants, shampoos, and sunscreens, for example, can all be considered drugs. Companies that want the approval of the FDA to sell their new prescription drug in the United States must test their product in numerous ways. The first tests are done in a laboratory and often involve testing on animals. The next tests involve humans and diagnose the drugs safety 7/7/11 Introduction The drug sponsor may begin clinical trials once FDA approves this application. At this stage, drugs that have not yet been approved for public use are called investigational or experimental drugs. The current FDA standard follows a three-phase process of human drug testing in accordance with pre-market approval safety and efficacy requirements....
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Presentation Powerpoint for Senior Sem - Click to edit...

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