Ensuring Consumer Safety: Toward Redefining the U.S. Food and Drug Administration

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 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 was founded on June 30, 1906 by then US president Theodore Roosevelt and Harvey Washington Wiley. It was formed as a response to serious abuses that were taking place at the time. In the government structure the FDA is a federal independent executive agency so that means that it is like a cabinet but it doesn't have the statues that some other agencies would have. And now I will go over why the FDA is necessary and what they do in it.

1) The FDA regulates foods, including dietary supplements, bottled water, food additives, infant formulas, and other food products, although the U.S Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products. The FDA regulates prescription and non-prescription drugs. The FDA regulates biologics, including vaccines, blood and blood products, cellular and gene therapy products, tissue and tissue products, and allergenics. The FDA regulates medical devices, including simple items like tongue depressors and bedpans, complex technologies like heart pacemakers, dental devices, and surgical implants and prosthetics. They also regulate electronic products that give off radiation, including microwave

The Food and Drug Administration (FDA) is a division of the Department of Health and Human Services (HHS) and received its name in 1930. Although the FDA’s roots can be traced back as far as 1862, its right as a regulatory agency came into effect under the 1906 Pure Food and Drugs Act. This legislation was created to eliminate misrepresentation of food and drugs in an effort to protect the health of the public. Over the years, the FDA’s role has further evolved to overseeing many areas other than just food and drugs. However, its mission has remained the same:

The United States Food and Drug Administration, also known as the FDA, is the government agency “responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological product, medical devices, our nation’s food supply, cosmetics, and product that emit radiation.” It is “also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable. Created under the Theodore Roosevelt administration under the 1906 Pure Food and Drugs Act, the FDA still operates as a part of the federal bureaucracy. What if the very institution supposed to be looking out for the public health and advancement of medical

The Food and Drug Administration is a regulatory agency responsible for the public health of American residents. The agency is located in Silver Springs, Maryland. The current extent of FDA regulations reaches a wide variety of product groups such as electronic devices, cosmetics, foods, biologics, tobacco, medical devices, and veterinary devices (US Food & Drug Administration, 2016). The FDA is also accountable for the safety of the food supply, prescription drugs, and the manufacturing of products such as tobacco (US Food & Drug Administration, 2016). The FDA’s organization is divided into five offices: office of the commissioner, foods and veterinary medicine, medical products and tobacco, global regulatory operations and policy, and operations (FDA Organization, 2016). According to the FDA website, the President’s 2016 fiscal year FDA budget is 4.9 billion dollars (2016 FDA Budget Summary, 2016).

The main goal in Phase I is to find out if the investigational new drug is safe. In this first phase of human testing, testing determines the correct dosing and exposes the most common side effects. If the investigational new drug is found to be safe, Phase II of human testing can begin. The main goal of Phase II is to find out if the investigational new drug is effective. Unlike in Phase I, the patients tested in Phase II are not healthy. In this phase, testing determines whether the drug works on patients it was designed to help. Results are obtained by comparing the group of test patients to other groups taking a different drug or taking a placebo.

The U.S Food and Drug Administration (USFDA) is the government agency responsible for ensuring the safety and efficacy of drugs and medical devices in the USA. The two legislative acts that are the main source of the FDA’s authority are:

The Food and Drug Administration dates back to the late 1840s, though it did not adopt that name until 1930. The first act if the FDA as it is known today was officially established in 1906 with the passage of its first piece of legislature. was the passage of the 1906 pure food and drug act, which prohibited the interstate commerce of misbranded food and drugs, and thus establish the FDA . It was established by the government, and thus inherited sits bureaucratic structure. ome of its flaws . Furthermore , the FDA was established as a council to regulate agricultural products through chemical analysis, and thus its structure is incredibly flawed

The Food and Drug Administration agency, or more commonly referred as the FDA, is a federal agency that takes charge in protecting the public’s health by certifying the safety, efficiency, and security of civilian and veterinary drugs, biological products, and medical technology; in addition to certifying the safety of our country’s food, supply, cosmetics, and productions that involve radiation. Not only does the FDA have that responsibility, but also the regulation of manufacturing, marketing, and distribution. The FDA advances the public health by amplifying innovations that create medical products more effectively, safer, and affordable where civilians can gain access to, all the while receiving science-based information they need to

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

These new guidelines will allow for a 12-year period of data exclusivity for new branded biologics. During the 12- year period, rivals are not allowed to use any prior data to try to come up with their own product. Before, the passage of the ACA, the Federal Drug Administration (FDA), could not legally approve new biologic medicines because they had to have clinical trials. This law opened up the regulatory guidelines for the FDA to approve

Physicians must prove that there is no other comparable or satisfactory alternative in order to diagnose, monitor, or treat their patient’s condition or disease. They must also conclude that the potential risk of the product is not greater than the risk of the disease or condition (Expanded Access 1). The FDA must also determine that here have been enough tests done already to provide sufficient evidence as to the safety and effectiveness of the product and its use in the case (Expanded Access 1). In addition, the FDA must also be certain that by providing this product to patients outside of the clinical trial it will not interfere with the clinical trial, and the FDA acceptance of the drug (Expanded Access 1). Another requirement is that the company developing the pharmaceutical product, or the clinical investigator, submits a treatment plan (clinical protocol) for the patient, which must follow the FDA’s regulations for INDs (Investigational New Drug) or IDEs (Investigational Device Exemption Application), which describe the use of the investigational product (Expanded Access 1). Pharmaceutical companies must also submit a draft of the Data Development Plan (Expedited Access Pathway Program).

After all research has been conducted including the testing of all animal and human studies associated, the New Drug application is completed by the drug developer. The results provided are used by the FDA to determine whether the drug is approved or the recommendation of further testing. Finally phase four is based on the monitoring of the drug’s risks and benefits monitored by various sponsors hired by the FDA.