Astrazeneca's Drug Industry

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.

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

In the video Escape Fire, I was so flabbergasted by the numbers and health outcomes we as a society have let our nation become. One of the most heart-wrenching evidence is, even though our health care industry is so expensive our health outcomes are the worse. 75% of disabilities and dead’s are preventable, according to the film.

The United Sates Food and Drug Administration has been protecting American consumers for around 70 years. The FDA assures the safety drugs, medical devices, chemicals, cosmetics, foods and additives by evaluating products for approval. Controversy has recently been surrounding the FDA's drug approval process, due to a general trend to get pharmaceuticals on the market more quickly. The FDA has been under pressure from congress and the public to speed approval, but pharmaceutical companies, who benefit more than anyone form accelerated drug approval, have also been applying pressure to the FDA through congress. The speeding of the approval process helps patients with incurable illnesses

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).

On september 2nd 2011, a Twenty-four year old man from cincinnati named Kyle Willis´ fell victim to the corruption of the pharmaceutical industry(Gann, Carrie). Willis had a severe toothache on his wisdom tooth that resulted in its extraction. After the surgery, Willis´s face started to swell and was sent to the emergency room. He was prescribed antibiotic medications and also painkillers in order to follow standard recovery procedure. Kyle Willis’ could not afford both drugs so he just purchased the pain killers because of the swellings unbearable pain. The infection continued to spread into his brain which lead to severe brain swelling and eventually Kyle Willis’ death. Kyle Willis’ died because he could not afford the medication that would have saved his life. There are many other people that can 't afford the drugs they need, which results them losing their lives. According to harvard studies, over 45,000 people annually die due to lack of health care coverage(Harvard Gazette). According to their studies, those who are privately insured have 40% chance less of dying than those who have insufficient funds(Harvard Gazette). The monopoly and corruption of the pharmaceutical industry is un-american and inhumane because it causes the middle class to not receive the help they need to recover.

To better understand the issues associated with the prescription drug industry, it would first be best to understand their development and approval process. For a new drug to enter the market, it must first undergo a lengthy and often expensive research and development. Once a company submits an application for a new drug, it is their responsibility to provide the evidence showing its safety and effectiveness. Until they have undergone these criteria of guidelines and standards set in place, they will not receive FDA approval.

There are two modern Food and Drug Administration (FDA) actions that are important to review and their impact today; the Prescription Drug User Fee Act passed in 1992, and the Food and Drug Administration Modernization Act passed in 1997. Under the Prescription Drug User Fee Act, the FDA was authorized to “collect fees from pharmaceutical companies to review their drug applications” (Shi, 2016). This fee collection process shortens the time for new drug approvals and allows the FDA to make the drugs available for use much sooner. Congress went a step further by with the Food and Drug Administration Modernization Act that provides for

This formed trade-off leads the FDA to unpleasant consequences which is why it’s important for them to collect information, about the drug and the political parties involved, that can help determine when to reject or accept a reviewed drug. In addition to that, delaying an approval can cause issues with the political parties involved in the drug or the specific disease. With new drug application (NDA), it gets a bit tricky. First, if an NDA for a disease with very few to no recent drugs being developed was reviewed, it would be hard to refuse it due to possible political consequences. Second, the FDA puts its reputation at risk everytime an NDA is being reviewed and possibly approved. Furthermore, the decision for a drug is based on three important characteristics: inherent uncertainty, asymmetric observability of error, and low reputational

The Pharmaceutical industry has been in the spotlight for decades due to the fact that they have a reputation for being unethical in its marketing strategies. In The Washington Post Shannon Brownlee (2008) states, “We try never to forget that medicine is for the people. It is not for the profits. The profits follow.” This honorable statement is completely lost in today’s world of pharmaceutical marketing tactics. These tactics are often deceptive and biased. Big Pharma consistently forgets their moral purpose and focuses primarily on the almighty dollar. Big Pharma is working on restoring their reputation by reforming their ethical code of conduct.

What some viewed as “overregulation” was criticized for being “unnecessarily cautious and bureaucratic” and there was an increasingly pertinent pressure from the industry and economic conservatives to speed up the new drug review process. Some research showed that throughout this era of regulation, the typical new drug took more than 12 years from initial synthesis to FDA approval and that the FDA review process by itself took 2.6 years. However, because public interest and opinion continued to align with the idea that the FDA should aim to prevent the sale of unsafe or ineffective drugs in the U.S. in hopes to avoid Type I errors in drug approval, the agency was not immediately responsive to this pressure. This alignment, however, shifted in response to the AIDS epidemic and the activism that came with

Across the United States, access to healthcare is a growing problem. For example, citizens are not allowed access to potentially life saving medications, if they have not been approved by the FDA. Now, in theory, this should be a fine system by which the FDA, a federal government organization dedicated to medication research and safety, receives research on new experimental drugs and either approves, requires more research, or denies it. This is the case, but with one drastic problem: restrictions and time. The FDA is notoriously known for the numerous amount of years it takes them to approve a medication for access to doctors to prescribe. Unlike other parts of the civilized world, where drugs, like mifamurtide which is used to treat a

One of the most significant changes the 21st Century Cures Act would make is altering the FDA's current "breakthrough therapy designation" program, which began in 2012. Under that law, the FDA can speed up the review process of drugs whose early clinical evidence demonstrates particular promise in treating serious or life-threatening diseases. The new bill would additionally allow the agency to grant market approval for drugs that are given the breakthrough designation. Once the drug was on the market, further clinical trials would be required.

Most people think the FDA approves all drugs on the market today, but that's not true. Some drugs are not subject to FDA approval (ex. "compounded" drugs), and others are only reviewed after they're put on the market.

Yes, there is an impact on the pharmaceutical company, like those in the US as a result of differential prices between that country and other nations.