Abstract
In this article, the writer looks at the history, aims and actions of the Food and Drug Administration (FDA). The writer notes that during its evolution, the Food and Drug Administration has encountered numerous important problems which have created the necessity to enact and implement many laws and legislation. The writer discusses that the FDA petitioned for changes in laws concerning, among other issues, the quality of foods and the therapeutic claims of drugs. In conclusion, the writer maintains that the Food and Drug Administration is a professional and ever-evolving agency which has acted not only as a pioneer but has also maintained itself as a world leader in its field. Of course, leadership is a lonely road and despite recent criticism and media backlash, the writer feels that the agency has done an excellent job protecting the American people and has upheld its mission statement to the best of its ability.

From the Paper
"Generally speaking, drugs were considered adulterated when their standards of strength, quality, or purity differed or fell below that of the United States Pharmacopoeia or National Formulary. Misbranding occurred when drugs were imitated, offered for sale under the name of another product, and/or the contents of the package having been wholly or partly removed with other contents put in its place. Misbranding also took place when the package failed to state the presence of alcohol, morphine, opium, cocaine, heroine, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate or acetanilide on its labeling. Confectionaries were considered adulterated when they contained alcohol, any narcotic drug, terra alba, barites, talc, chrome yellow, other mineral substances, poisonous colors or ingredients detrimental to one's health."

Tags:misbranding, health, legislation, therapeutic, substances

Abstract
This paper examines the process to get a drug to market. The paper specifically focuses on the case of the drug, Viagra. It looks at the patent laws on new drugs and how drug companies will often try to extend their patents to extend the fiscal life of a drug. The paper discusses the essential stages of the Food and Drug Administration (FDA) process to approve new drugs and how the public can have access to cheaper generics while maintaining the quality of the product.

From the Paper
"For pharmaceutical drug companies like Pfizer to remain profitable and continue to offer premium products, the solution is simple. Give the new drug's inventor the exclusive rights to sell the drug for 15 years after the day the drug is approved. Currently, patents protect drugs from copycat versions for 20 years after the drug is invented. Since it often takes eight years or more to obtain approval, this essentially reduces the patent expiration to less than eleven years. Expensive lawsuits eat into the company's profit margin, inhibiting their ability to continue research and development into other drugs. In short, this solution will still give the public access to cheaper generics while maintaining the quality of the product."

Tags:generic, patent, Pfizer, patent

Abstract
In the United States, the government and its agencies do not maintain the same regulation of herbal remedies in the same way that they ensure the safety of other foods and medicines. Furthermore, while these products were once the mainstay of only such minute groups as vegetarians and other counterculture types, they have now become widely popular among the general public as the widespread assumptions about their safety and naturalness has permeated contemporary society. The paper argues that, on the other hand, many professionals within the medical community conversely claim that the dietary supplement industry is selling modern day snake oil that has no proven safety or efficiency. In the end, both factions are correct, and in spite of the natural base of herbs and dietary supplements that can make these products appealing even when traditional medicines are not appropriate, these items are also powerful medicinal agents. The paper shows, therefore, that due to the public's lack of ability to make informed decisions surrounding these products, the Food and Drug Administration must be granted the same sovereignty over herbal remedies and vitamins that it maintains over other foods and medicines.

From the Paper
"Still, one reason that some people believe that it is not necessary for the government to become involved in this industry is indeed largely because of the mistaken belief that these agents are safe merely because they are natural. In fact, according to one 1997 poll, more than half of consumers who use natural remedies are convinced that they are equally as safe and effective as traditional treatments like aspirin ( Greenberger 1077). However, since 1994 there have been reports of at least 34 deaths and nearly 900 adverse reactions--including heart-rhythm disturbances, heart attacks and strokes associated with supplements that contain one herbal stimulant that is often taken to boost energy and to lose weight (Josefson 1440)."

Tags:dietary, stimulant, toxic, commissionar

Abstract
The paper relates that the FDA has been accused of being too slow as well as lacking oversight and in need of even more periodic reviews of previous approvals. The paper discusses the pressure from patient groups as well as doctors and pharmaceutical companies to expand the FDA approval and testing process to include experimental drugs. The paper devotes time to the politicization of the FDA and the accusations of bias towards the pharmaceutical companies. The paper also reveals that many American pharmaceutical companies are now outsourcing their clinical trials, which might make it more difficult for the FDA to follow every step of the trial method and results.

From the Paper
"Just what does the FDA do? Government documents state that the FDA seeks to protect the public health by ensuring the purity and security of foods; the safety and effectiveness of drugs, medical devices, biological products, and radiation-emitting products; and the safety of cosmetics. The FDA oversees the review and approval of new medicines and medical devices. It also monitors the safety of dietary supplements, though it does not review and approve the supplements before they are sold.
"The FDA helps to ensure that people receive accurate information about the foods and drugs that they use. The agency calls for the truthful description of product benefits and risks and for safety and honesty in packaging. In fact, the information about contents and dosage found on food packages was developed by the FDA."

Tags:oversight, testing, safety, medication, lobbyists

Abstract
Discusses the historical origins of the agency's legislative powers and duets, its operations and impact, the FDA's power over the approval or rejection of a new drug or device, and the life or death consequences if approval is delayed.

From the Paper
"This research paper summarizes and discusses the role of the United States Food and Drug Administration (FDA) in the regulation of health, the historical origins of its legislative powers and duties, its operations and their ..."

From the Paper
"Twenty-five percent of the American consumer dollar is spent on products regulated by the Food and Drug Administration (FDA). Each day in America there can hardly be an individual or, for that matter, a pet or stock animal that does not eat foods, take drugs or use devices that have been, at some stage, regulated by the FDA. The control of such a vast array of products has generated a large bureaucracy that has been under intensifying siege for the last fifteen years. The terms of the siege vary considerably. The deregulating impulses motivating the Reagan-Bush administrations produced as much criticism of the FDA as have the pro-regulation feelings of consumer advocacy groups. The agency has been criticized for its excessive indulgence of the industries it regulates and it has been accused by these same industries of producing pointless barriers to economic and..."

Abstract
This paper examines the role of the U.S. Food and Drug Administration in the process of approving new drugs. It also examines the history of the FDA and its relationship with pharmaceutical manufacturers.

From the Paper
"According to an essay written by John P. Swann and published on the U.S. Food and Drug Administration website, the history of the FDA has been closely intertwined with the history and growth of the pharmaceutical industry. The FDA was founded to help safeguard the health of Americans by regulating America's food supply as well as the growing pharmaceutical industry. The FDA is charged with ensuring that drugs sold in the United States meet certain standards of effectiveness and safety..."

Tags:US Food and Drug Administration, food, drug and cosmetics act, FDA, pharmaceutical industry, regulation, new drug approval process, pharmacists, controlled substances, clinical studies, testing, efficacy

Abstract
The U.S. Food and Drug Administration regulates many of the products you use in every day life. Yet, there are many drugs on the market that have not been approved by the FDA. This paper examines the legal and ethical issues that surround these lawful, yet unapproved by the FDA, drugs that are on the market.

Tags:drugs, fda, unapproved

Abstract
This paper examines the debate between the East and West on the issue of safety on genetically modified food. The author looks at the argument concerning the food's safety, and possible effects on the human body, labeling of such products, and how the U.S. Food and Drug Administration use modified foods.

From the Paper
"The world as we know it is divided into two parts---the secular West and the cultural East. Both have different manners of living and while the West blooms in progress the East is more restricted as it looks for the morality and values behind the progress being made. In such a division controversies like genetically-engineered food bring home the difference as both the divides through the globe argue the safety of the food-albeit on different grounds. At the heart of the debate lies the argument that as yet, the effects of genetically modified crops and products on the human body are not known. However, there is no conclusive evidence of whether or not they can be harmful.."

Tags:east, west, FDA, poison, biotechnology, risk, label, population, health

Abstract
The paper looks at how the US Food and Drug Administration has on its website a counterterrorism initiative that admits that there are five critical challenges that need to be met effectively in order to protect Americans from the threat of bioterrorism. The paper explains that rapid response and increased security of food and drug imports are the main goals of the FDA's initiatives. The paper also discusses how the FDA has plans to step up the monitoring of import procedures and increase inspection of the food and drugs imported into the US.

From the Paper
"The importation of drugs into the U.S. after they have been exported is an unsafe practice because it can provide an opportunity for terrorists to organize an attack. The possibility of terrorists utilizing internet drug companies to create an avenue for an attack is a realistic concern. The unpredictability and wide variety of ways that potential acts of terrorism can be devised complicates preparedness and the ability to quickly and effectively respond to such an attack (Counterterrorism, 2004)."

Tags:safety, bioterrorism, counterterrorism