Regulatory Paper

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Regulatory Paper
Sonia Young
University of Phoenix

Regulatory for FDA

The Food and Drug Administration is a government agency which is referred to as the FDA. This agency is responsible for protecting the public’s health in a variety of ways. They help to assure the safety, efficiency and security of medications, both human and veterinary. Some other areas they cover are biological products, medical devices, our food supply, and cosmetics. Another area the FDA helps in is research to help improve individual’s health by improving food and medication. As of last year 2010 over one trillion dollars worth of the various products are regulated by the Food and Drug Administration. A better break down by category; food sales is over four billion dollars and drugs/medications is about three billion. The food and drug administration does handle one third of all the imports into the United States (FDA, 2010).

            Some individuals do get confused as to what the FDA is responsible for ensuring that foods we eat are safe, wholesome and sanity (US FDA, 2010). These are the individuals that make sure that all cosmetics, food and over the medications are properly labeled. Some of the areas the food and drug administration do not regulate are illegal drugs, meat and poultry, alcohol labeling, grocery stores and water. The drug enforcement administration agency takes care of all illegal drugs. The department of justice’s bureau of alcohol and tobaccos deal with the labeling and alcoholic beverages. The Environmental Protection Agency deals with purifying bottled water. The Consumer product safety commission regulates the safety of appliances and most consumer good (FDA, 2010).

Statutory and regulatory law the stature creates an agency and authorizes it to pass laws regarding specific issues. For instance, the Food and Drug Administration is a federal agency that can pass rules governing the sale of food and drugs. The rules or laws made by agencies are called regulations(Fremgen,2009).

FDA History

The Food and Drug Administration was started in the early 1900’s. In 1938 the Federal food, drug and cosmetic act went into effect because 107 individuals died due to toxic elixir. President Franklin D. Roosevelt was the president that signed the federal food, drug and cosmetic act. With this act in place the Federal food, drug and cosmetic act let the Food and Drug Administration have authorization to demand documentation from manufactures. One of the areas the Food and Drug Administration helped to regulate is over the counter drugs. This type of drug does not require a doctor’s prescription (FDA, 2010).

Through the years FDA has a list of all the approved ingredients that are combined in different ways to create new drug products. Many of the over the counter drug ingredients were approved in other prescription drugs that have been tested to be safe without a prescription. The FDA also has input into the generic drugs that are out on the market. Generic drugs are medicines that are sold in pharmacies that have the same equivalent of a name brand drug but the patent has expired on these medications. When individuals go to the doctor they normally try to write the prescription for a generic drug instead of a name brand drug because of the difference in price. Of all the prescriptions that doctors write approximately a third of the prescriptions they write are for a generic brand. The FDA makes sure the scientific evidence that the medication is interchangeable or is a therapeutically equivalent to the originally approved drug (FDA, 2010).

Actual Case

In 1989 there was a scandal going on which involved the Food and Drug Administration. This scandal where the FDA wanted to approve all individuals to buy generic drugs that they approved and the drug never should have been approved. During this time in 1989 three officials pleaded guilty for accepting bribes from generic drug makers. Along...
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