According to the Food and Drug Administration (FDA) they are in operation to help protect public health, primarily by ensuring that companies prove the safety and efficacy of drugs/devices, manufacture them properly, and market them appropriately. Almost every investor has probably heard stories of the traveling medicine shows of the 1800s and early 1900s where frauds sold various "patent medicines" that, did not cure anything and at worst were actually quite harmful. (Stephen D. Simpson, 2014)
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,
In 1906 the Food and Drug Act was officially created by the president at the time that was Theodore Roosevelt. The job of the FDA is to protect the health of the public and doing so by assuring that human and veterinary drugs are safe and secure along with biological products, medical devices , food supply in the US, cosmetics, and products that have been introduced to radiation. It’s important because they ensure the foods you are consuming can be eaten without getting you sick. They also ensure the medicine you get is not going to cause harm to you. Without the FDA the drugs we get from pharmacies and the food we get from stores would have the possibility of being very unsafe and hurtful. The FDA has created many regulations that products have to go through to be considered FDA approved. Some of those include the safety of the food we consume, products that contain tobacco, dietary supplements, medications from pharmacies, vaccines, and blood
Secondly, it reduces the time for patient’s evaluation. Due to DTC, drug companies are rarely encouraged to research and evaluate the effect of drugs on patients. The companies do not research enough to evaluate the side effects of drugs before the drug administration. This will cause crucial damages to patient’s health. Same is the case facing by PharmaCARE who had to face negative consequences of drugs because the company was having lack of research before administrating the drug. Due to direct marketing, patents do not feel the need for taking doctor opinion and take self-treatment which sometime cause risk to patients life.
They have also attacked patent listings in the Food and Drug Administration “Orange Book” and have alleged monopolization through fraud on the Patent and Trademark Office and sham litigation. Yet other cases have condemned distribution agreements as unlawful exclusive dealing. These government actions have led to substantial private class action litigation against the pharmaceutical industry. The FTC has also challenged numerous mergers and acquisitions in the industry over the last decade. One common feature in all of these cases is the need to define a relevant market. In nonmerger cases, the FTC and private plaintiffsgenerally allege narrow markets, limited to a single drug and its generic equivalent in some cases and to generic drugs excluding the bioequivalent “brand-name” drug in other cases. In its merger challenges, on the other hand, the FTC has alleged markets ranging from those based upon a particular chemical compound, to broader markets based upon various drugs’ manner of interaction or dosage form, to still broader markets of all drugs used to treat a disease or condition. In numerous pharmaceutical merger challenges, the government has included in the market not only currently marketed drugs but also other drugs under development, alleging “innovation markets.”
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 FDA is responsible for protecting the public health by assuring the safety, effectiveness, quality and security of human and veterinary
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).
The Medicines Company used the saying “one man’s trash is another man’s treasure,” to the next level. It essentially took what other pharmaceutical companies place on the shelves and never use again as their next product which becomes a money maker. The idea is a great idea if it is well executed. The company cannot take just any type of drug and try to execute it pouring in millions of dollars’ worth of research and development because if the product is not chosen carefully, the product will fail. A simple failure for a drug that was not carefully selected, can damage the company’s image and reputation.
The FDA also looks at several products that have chemical implications to them, such as drugs. It looks at drug manufacturing standards, as well as the labels of each drug (both over-the-counter and prescription drugs) and must give its approval on new drugs before they can be sold to the public. The FDA also looks at cosmetics. It must ensure that, like food articles, each product is properly labeled as to what comprises each item. Biological products, such as the nation’s blood supply, are also regulated by the FDA. It does research to improve upon the testing methods of blood, to ensure that the supply in hazard free. It also is in charge of handing out licenses to product and manufacturing establishments.
The pharmaceutical industry is one of the most powerful and greedy industries in our country, with a goal to make as large a profit as possible, at the expense of the sick.
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 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.
Back in 2007 the FDA ruled that the bottles needed to have black box warning label on them, but since that time more evidence questioning its safety have emerged forcing the FDA to revisit the issue. Of course prescription drugs are not the only option for some diabetics. New technologies continue to come out making life easier on diabetes suffers. Diabetics used to have to go to a lag every few months, the wait days to get their results. Then technology made it possible to glucose testing at home with stripes. Then came along long insulin pens that replaced the need to inject insulin with a needle.
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.
Everyone loves a good bad guy. It seems to make complex issues easier to deal with when there is a scapegoat defined. Disease kills many people on a daily basis all around the world. However, many people view the big drug companies as evil profiteers in the fight against disease, wielding patents to protect their profits rather than wielding medicine to combat disease. Medicines have been created to combat disease which greatly improves survival outcomes and daily quality of life. Many of the large pharmaceutical companies are responsible for inventing and manufacturing a majority of the medications that have had this positive impact on society. Although it may seem that many view pharmaceutical companies as profiteering from illness via patents, people world-wide benefit from the process, especially when generic production is authorized. This would never happen without the current model utilizing pharmaceutical patents.
In the United States, a drug can only be advertised legally after being approved by the Food and Drug Administration (FDA). Once attaining at least one FDA-approved use, physicians can prescribe a drug for other unapproved uses, based on their clinical judgment; this is referred to as “off-label use” (McCambridge, 2008). In general, marketing drugs for off-label uses is illegal; however, pharmaceutical companies have gone to various lengths within their legal rights to accomplish exactly that.