Regulatory for Food and Drug Administration

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 with the three officials two companies also were charged and pleaded guilty for offering the bribes (FDA, 2010). Another result from this scandal was several drugs/medications were recalled and had to be taken off the shelves. This happened in the early 1990’s. Then there was a court case that was big in the news in 2006.

This case was known as the Abigail Alliance versus Von Eschenbach. From this case many charges with the Food and Drug Administration regulations on drugs that were not approved where changed. The Abigail Alliance wanted the Food and Drug Administration to license all drugs that were used for terminally ill patients with desperate diagnoses after testing was done. An appeal on the case won in May of 2006, but in March 2007 the decision was reversed after the hearing (FDA, 2010).

An incident occurred in June of 2009 where the Food and Drug Administration had to do a Class 1 recall on pacemakers.A “class 1” recall is a withdrawal of a product that is done due to the device used could cause serious health issues or possible death. These pacemakers were made by two separate companies Sigma and Medtronic Kappa. What caused the recall was due to the wires separating the connection from the electronic circuit to the component of the pacemaker.

The result from there wires separating if the device malfunctions will cause the patient to have symptoms they had before they received the pacemaker. Some of the symptoms include, but not limit to be light headed and irregular heartbeat (FDA, 2010). FDA StructureWith the cosmetic industry the Food and Drug Administration is the responsible agency. The Center for food safety and applied Nutrition is the agency that regulates the cosmetics. Cosmetics do not have to go through pre-market approval unless they have a “structure of function claim”.

A structure of function claim is when the cosmetics are made into a drug. This agency has made all cosmetic companies to let consumers know by having a label on the product that is/has not been tested for safety. Although the chemicals in the cosmetic products do not have to be required this label is required to be on the product.Many cosmetics have color additives in their products so the Food and Drug Administration must approve the color before they can be sold (FDA, 2010).

The Food and Drug Administration has many branches and one being the Center for Veterinary Medicine. The veterinary medicine branch is the subdivision which contributes in regulating activates in the food and drugs that animals receive. All animals need to be vaccinated by drugs, but the Center for Veterinary medicine is not the branch that takes care of the animal vaccination.One thing the FDA is trying to prevent is the spread of bovine spongiform encephalopathy.

The department that takes care of this is the United States Department of Agriculture. The only thing the Center for Veterinary Medicine makes sure of is the medications used for the animals do not get into the human food supply (HHS, 2010). The Center for Devices and Radiological Health also known as the CDRH is the branch of the Food and Drug Administration that is responsible for medical devices.This branch is the one who oversees the manufacturing, performance and safety of all medical devices for premarket approval.

Once they have passed this stage the Food and Drug Administration are the ones who approve the device before they go on the market. One of the common medical devices that the Food and Drug Administration oversees frequently is the pacemaker (FDA, 2010). Day-to-day Responsibilities The Food and Drug Administration contributes in regulating many areas to help make sure different foods and drugs are safe for the public.The Food and Drug Administration have branches that work with a variety of issues to ensure the safety of the various products. This government agency has different responsibilities for each category, but all the day-to-day responsibilities pertain to the welfare and safety of all individuals.

They make sure that medications being manufactured are safe and individuals can afford to buy what they need. These individuals make sure the manufactures are producing effective and safe food and medications. The subdivisions of the Food and Drug Administration allow the agency to be detailed in their approach.They are not the ones who manufacture the products. The agency and their subdivisions test the products before they can be approved for distribution.

The standards are set and met before the consumers are able to buy these products. They do not just take care of medications they also deal with equipment, animal food, cosmetics and biological products. This Federal organization works to ensure the safeties i. e. those products are free from impurities, in order to keep individuals out of harm’s way while using said products (FDA, 2010).

Conclusion The Food and Drug Administration 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. 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.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 this scandal was several drugs/medications were recalled and had to be taken off the shelves.

The early history 1990’s, then there was actual court case that was big in the news in 2006. This case was known as the Abigail Alliance versus Von Eschenbach. Structure of function claim is when the cosmetics are made into a drug.This agency has made all cosmetic companies to let consumers know by having a label on the product that is/has not been tested for safety. Different responsibilities for each category, but all the day-to-day responsibilities pertain to the welfare and safety of all individuals.

They make sure that medications being manufactured are safe and individuals can afford to buy what they need. These individuals make sure the manufactures are producing effective and safe food and medications. The subdivisions of the Food and Drug Administration allow the agency to be detailed in their approach.