The Politics and Economics of FDA Drug Approval Essay

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

When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the

The FDA is something that many people know about, but do not know what happens within the company. A majority of Americans have heard stories on the news of people making huge acquisitions of how the FDA killed their child by no correctly regulation fast food companies ; or how their husband died for a heart attack because the warning label on his bottle of medication was not correct.

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).

According to Miller, Benjamin, and North, “FDA bureaucrats decide whether or not new medicines (prescription drugs) should be allowed to go on sale in the United States” (Miller, Benjamin, and North, page 3). Prior to the 1962 Kefauver-Harris Amendments being made to the 1938 Food, Drug, and Cosmetic Act, the FDA was given a limited time frame of 180 days to approve or deny a new drug application. These amendments added a new “proof of efficacy” requirement and removed the 180-day time constraint, allowing the FDA to demand whatever

A job of the FDA is ensuring the safety of the nations food and drug products. One way they do it with food is by having manufactures send a report of the process that it takes to make the food so they can see if the process is a healthy or unhealthy one. The FDA do the same

The FDA is responsible for protecting the public health by assuring the safety, effectiveness, quality and security of human and veterinary

On January 4, 2011, the FDA Food Safety Modernization Act was passed. The law focuses on enacting better food regulations to prevent the public from any harm (Hamburg). This legislation allowed FDA to build a system that could hinder any dangerous problems relating to food safety before it could become a burden for the public health. The FDA is responsible for working with states and local government to provide assistance and form standards which can be followed across the United States. The new authorizations given to the FDA allowed for an important transition towards a more unified food regulation system in the United States. Overall,

The FDA also know as the Food and Drug Administration all based on the Federal food and Drug act. The act was passed in 1906. The FDA was founded to rein in long standing serious abuses in the consumer product marketplace. Harvey Washington Wiley was the chief chemist at the Department of Agriculture was a highly advocated for federal public health.

The Food and Drug Administration is a regulation agency within the Department of Health and Human Services. It’s role in our nation is to be responsible for “protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation” ("What We Do."). One of the most important responsibilities and the topic I will be discussing throughout this paper is drug regulation. The Food and Drug Administration approves drugs that are intended for use in diagnosis, cure, relief, treatment, or prevention of disease, and is intended to affect the function of the body. In order to do so, The Food and Drug Administration reviews drug manufacturer’s via application to put drugs on the market; therefore, a drug may not be sold or marketed unless it has and remains approved by the FDA. Even though a drug has been approved does not mean it will remain on the market, drugs have the likelihood to be recalled. For example, when you see those late night personal injury lawyer commercials saying, “If you have been prescribed and taken said drug, and experienced any of these side effects such as blood clots, seizures, etc., you may be entitled to compensation.” those drugs have usually been recalled due to adverse effects

The regulatory body in USA is the FDA, in the European Union the EMA, the European Commission and the national authorities of the EU member states and in the Canada the Health Canada handle the drug review processes. Each agency has their own distinctive approaches to approve drugs biologics and medical devices. The globalization of the pharmaceutical industry, harmonising the drug regulatory approval process of the US FDA and EU EMA, and Health Canada is essential to speed up the progress of new treatments. The main goal of all agencies is to put a drug in the market in safe, efficient and faster. We will examine here the agencies’ approval process time frame and other drug approval pathways.

This lead Americans to ask who is supposed to be regulating these drugs and why were they not doing their job. The Food and Drug Administration (FDA) is responsible for making sure that drugs are safe and effective before they are introduced to the public. However, once the drugs are approved and dispensed, the FDA’s job is still not done. After a drug is released to the public, it is the job of the FDA to monitor it and ensure that the drug is being used in the way it was meant to be used when created, but there are many loopholes the pharmaceutical field has taken advantage of. For instance, the FDA created a program called RiskMAPs which was designed to minimize the risks of a drug while still distributing the benefits of the drug to the public and is submitted to the FDA during the approval process of the drug. The loophole here is that RiskMAPs is optional and the FDA can only recommend that RiskMAPs is used. Another loophole is that the FDA is not exactly allowed to monitor how the drugs are advertised to consumers (Collins). Essentially, the FDA is totipotent in regulations before the drug is released to the public, but once it is released, the regulatory abilities of the FDA are minimal. The FDA is the main source of regulation when it comes to drugs, but individual

FDA legislation began under the Food and Drugs Act of 1906, and regulatory legislation followed throughout the 1900’s, bringing about legislation in 1996 to address the advancements in technology in the coming 21st century. As this paper gives a brief history of FDA regulation, and summarizes the Safe Medical Devices act of 1990 and the FDAMA 1997, it provides a lens into how external forces (legislators) can influence the safer and more efficient products produced in the health care

Phase III is the first large-scale trial of human testing. This phase can only begin if the new drug shows to be effective in Phase II. Phase III seeks to further determine the effectiveness of the drug. This is done by testing the drug on different populations, meaning that testing will be done on more people, testing will be done with different drug doses, and the drug will be tested on patients who are also taking other drugs. If Phases I through III show the investigational new drug to be safe and effective, then the pharmaceutical company will file a New Drug Application (NDA). The NDA includes both the results of the first three trial phases and data on how the drug is manufactured (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001; Krishna,

“One of the best things that Congress ever did we believe was create the drug approval process that set up a process for drugs to be approved as safe and effective by the FDA and manufactured under very strict manufacturing controls with very stringent marketing controls and regulations by the states, physicians and pharmacies” (108th Congress 1st Sess., 2003, p. 16).