The Use Of Biologics And Medical Devices Should Be Strict

Americans have access to and benefit from one of the most technologically advanced pharmaceutical systems in the world. However, this system is also very strict and tedious. The system this paper will evaluate is the United States Food and Drug Administration (FDA), more specifically, the FDA’s Center for Drug Evaluation and Research (CDER). Although, having access to this system can be frustrating to those that are in the pharmaceutical development industry or those that have illnesses and need the best drugs available in order to cope with their symptoms.

The FDA has a very serious job with food and medication.They are responsible for most of the things that have to do with food and drugs.They require certain things for a food or drug to be allowed to be sold.They have to make sure that every single medication or food is in very safe and good conditions.If it wasn't for the FDA the country would have very unsafe medications and foods,specially medications many people would use drugs and other medications without knowing if they are effective or if they just hurt people more.The FDA has a time limit,during this time they have to check every medication and food to make sure they are in very safe conditions for the people and to do this they get help from scientist who run test on drugs and foods to verify there is no toxic or illegal drugs in

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.

I personally feel that the FDA can and does impede the efforts of growth in many health care facilities. I do agree they are there to help protect the consumer in many ways. But The FDA has the ability to ban the import of medication from other counties,

Pharmaceutical companies are provided with temporary monopoly rights on the production of new drugs which result in a higher cost on consumers. If competing companies were allowed to produce generic forms of those drugs, consumers will be able to afford those medications even in cases where those consumers have no insurance coverage. The company responsible for developing and inventing the original medication could be offered incentives to invent in the future by either obtaining tax breaks or NIH funding for future research. They could even be offered a percentage of the sales of the generic drugs. Economist Gary S. Becker advocates dropping many FDA requirements that, in his opinion, provide no additional safety measures but rather delay the development of new drugs.[12] Betamethasone, for example, has been part of the standard prenatal care in Europe since the late 1970’s while it got adopted in the U.S. after 1997. On many occasions, the FDA ignores all scientific evidence concerning certain drugs because the manufacturer did not follow their mandated bureaucratic standards.

A regulation exists to protect a patient’s safety – on its own it doesn’t mean that there is scientific evidence that a treatment is effective.

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.

Americans must wait up to 19 years after a discovered treatment before they can participate in benefits of a new medication (Philipson & Sun, 2008). The regulatory process drug manufacturers need to endure before releasing potentially life-saving medication is an extremely expensive, time-consuming process. The Center for Drug Evaluation and Research (CDER) is the main department of the Food and Drug Administration (FDA) responsible for the safety of drugs (both prescription and over-the-counter) sold in the United States (Food and Drug Administration, 2011). This department scrutinizes the testing of new drugs and

It was said by the CEO of Apple that, “Technology is nothing. What’s important is that you have a faith in people, that they’re basically good and smart, and if you give them tools, they’ll do wonderful things with them.” (Iz Quotes) In this day and age, technology has infiltrated society in more ways than can be imagined, even in terms of the medical field. Biomedical technology is the use of new advances in terms of computers and electronic devices to assist in saving lives and making new strides in medicine. The question remains, however, whether this technology helps or hurts people in the long run, and whether the use of it should be restricted. This is a relevant issue in society for the reason that it can help save people, or it can hurt or possibly even take their lives. (ProQuest Staff) It also raises the question as to whether technology is completely replacing people. The use of biomedical technology should be restrained, but not completely eliminated, for the reason that it improves the way that doctors and physicians are able to care for the sick. Nevertheless, it is important to realize that the use of technology should come second to the actual doctors, since the skills truly lie in the hands of the people that use them, rather than in today’s advanced technology, as can be ascertained from Mr. Jobs’ quote. Technology can enhance people, however, moderation

Everyone in America, is at risk for being diagnosed with a condition that they don't have, and being prescribed medications they do not need. Its, everyday advertisments on TV for clients who may have had a missed diagnosis, and experienced a side effect from a medication they where prescribed, physicians try to follow national standards of care to protect themselves from lawsuit or even losing their licenses.

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

The final move was the 1962 Kefuaver- Harris Amendment, which tightened safety requirements and also recquired the manufacturers to provide FDA with evidence that the drug was both safe and effective for its intended clinical purpose. People of the drug industry were outraged because this would delay, often by many years, the time and cost of which a company could market a new product and begin to recoup its investment.2

Due to the fact that because drug trials were poorly regulated in the early 1970’s Phase I research was conducted on prisoners. The FDA was granted authority to monitor research that involved humans in the 1978; at which time, the FDA ordered each institution to devise an Institutional Review Board (IRB). The IRB was to generate and monitor the rules of the trials on all studies done within the universality. The IRB was comprised of faculty members who volunteered to evaluate their colleagues’ studies. Unfortunately, before 2005, FDA inspectors’ primary focus was on verifying the clinical trial data, not the human subjects involved in them.

There were two important developments in the 1970s which further shaped the industry in the form that we see today. Firstly, the Thalidomide tragedy (where an antiemetic given for morning sickness caused birth defects) led to much tighter regulatory controls on clinical trials, greatly increasing development costs. Secondly, enactment of legislation to set a fixed period on patent protection (typically 20 years from initial filing as a research discovery) led to the appearance of “generic” medicines. Generics medicines are those that have exactly the same active ingredients as the original brand, and compete on price.