Fda 's Drug Approval Process : History, Pre Market, And Post Market

The FDA has come a long way since 1906, but in my opinion, I believe that the FDA should do more to protect our health and have stricter laws in place concerning our food and medicines. The FDA allows products to be on the market without prior approval; for the FDA to take action and recall a product something awful like multiple deaths have to happen for them to realize that the product is harmful. Prime example, Red #3 is food coloring that FDA permits in our food to make the food look appealing. However, studies done on animals have proven to show that Red #3 causes cancer. According to an article published in 1990 in the New York Times states that "Red Dye No. 3 still has some approved uses in foods and drugs, but the F.D.A. said it is

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter.

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

The Food & Drug Administration became a possibility because of the Pure Food and Drugs Act of 1906. Harvey Washington Wiley was the driving force behind this law and headed its enforcement, which provided basic elements of protection that consumers had never had before (FDA's Origin). The FDA is an agency that works within the US Department of Health and Human Services of the executive branch of government (About FDA). The Food and Drug Administration is responsible for protecting the public health of all Americans by ensuring the safety, efficacy, and security of a large range of products from drugs to cosmetics (What We Do).

A terrible incident happened in Tennessee in 1937 when a drug called Elixir Sulfanilamide was mislabeled and contained toxic quantities of antifreeze that killed over 100 people (FDA's Origin & Functions - FDA History). Before this event, Congress debated substituting the 1906 Act and this instance in Tennessee drove Congress to approve the Food, Drug and Cosmetic Act of 1938 that provided an updated set of standards. Unlike before when the government had to disprove a drug was effective, the new act stated that drugs had to be proven effective before being sold. It not only replaced the Pure Food and Durg Act, but the Sherley Amendment as well (Centennial Edition of FDA Consumer).

The Food and Drug Administration (FDA) and United States Department of Agriculture (USDA) are government agencies that coordinate with one another to ensure the safety of our nation’s food supply. For instance, the FDA is responsible for protecting the public health by assuring safety, effectiveness, quality and security of human/veterinary drugs, vaccines, and medical services. In addition, the FDA is also responsible for all cosmetics and dietary supplements, tobacco and products of radiation. There is a law in place, which has been recently signed by President Obama on January 4, 2001 called the Food Safety Modernization Act. This reformed food safety law is over sighted by the FDA agency to ensure that the U.S. food supply is safe, by focusing on ways to prevent contamination from previously reported

There was a time where there was no limits to what substances were in products we humans consume or use everyday. It is alarming to think that there could be items in our food or medicine that are potentially dangerous and deadly. It is for these reasons that the Food and Drug Administration came to be. It all started in a time where companies could say anything they wanted about a product without any scientific validation or proof. The government stepped in and established the Pure Food and Drugs Act of 1906 along with a new agency: the FDA. This act's purpose was to protect the public against dangerous substances in food and from products identified as healthy without scientific support. This law was an accumulation of many bills and ideas that aimed to protect consumers from contaminated products. (The Pure Food and Drug Act) Now, the FDA conducts recalls, market withdraws, and safety alerts in order to protect the citizens.

When I was a kid, I always wondered why it took so long for an ill person to become well again. I always thought that if the ill person went to the doctor they would be back to normal the next day, but that’s not the case. For some people it took several days, weeks, months, and even years to conquer an illness but as a child I never could understand that. I don’t know how many times I’ve asked my mom or dad how come the doctors don’t get together and make a “miracle” drug that could heal anything and everything. It wasn’t until the age of 15 when my grandmother was diagnosed with breast cancer that I understood why it took so long for others to heal and the process that they had to endure in order to be healthy again. Shortly after my grandmother’s diagnosis, I started looking into what it would take to get a drug that would cure cancer through the approval process on the shelf to save some many others just like my grandmother. But I kept running into a dead end. Everything seemed to keep pointing towards chemotherapy and radiation. Although I wanted something to heal my grandmother fast, chemotherapy and radiation was the only solution if I had wish to see her watch me graduate high school. I went to almost every appointment with her to watch how it helped strengthen but also watch as it drained her energy. A month of chemotherapy and a few weeks of radiation and my

There are many direct to consumer advertising for prescription drugs. On television, magazines, radio etc, you see the most recent advertisements for prescription drugs. After some people see the advertisements they soon rush over to their doctor and their illness and life would be perfectly pain and stress free. Making the public conscious of options for treatment is not a bad thing. But these false advertisements are misleading consumers onto unnecessary treatment.

This article fits nicely with our current topic, The Bureaucracy, because it demonstrates the power of the Executive Cabinet. The FDA, which resides under the Health and Human Services department, has the ability to discern between what products can be released for general consumption and, as a brief analysis of its role, ultimately determines whether a product can be sold.

The year 2000 brought about the reversal of the FDA’s ruling and regulation of tobacco as a drug. Further protection for children came in 2002 through the Best Pharmaceuticals for Children Act, which further improved the efficiency and safety of drugs for children. In 2003, drugs marketed for use in animals came under the FDA protection umbrella. The Animal Drug User Fee Act helped to ensure the safety of drugs used in veterinary settings. In 2004, in response to potential terrorist attacks, the BioShield Act allowed the FDA to expedite the approval process of drugs to treat potential chemical, nuclear, and biological contaminations (FDA Milestones, 2006).

Clinicians and patients recognize the tremendous importance of medications in today 's medical care. Associated with the development of the pharmaceutical industry, its consumption has been increasing, and with it, the possibility of unwanted effects or adverse reactions.

As mentioned in class, as well as in the required Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug’s mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008).

In short, the sole purpose and mission of the Food and Drug Administration is to check and maintain the safety of all our foods and drugs from causing the citizens harm. Without the FDA, the lives of Americans will be exceedingly more complicated, having to know and learn which types of medicines are safe and if their food is edible. The FDA is a large government organization and this paper will only focus on the FDA’s Drug department.