Essay on Off-Label Use of Prescription Drugs

Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.

With access to prescription drugs, people are able to treat a multitude of diseases and illnesses. These drugs help deal with pain, inability to sleep, depression, and much more. Every day we are increasingly living in a world where there is better living through chemicals. However, what most do not seem to see is the rising tide of pain, illness, and ultimately death being caused by the pills people take every day. Most keep drugs in a special place in their minds, where they see them as harmless. Sadly, this is not the case, and in some cases our prescription drugs can be just as harmful as illegal drugs (King 68).

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.

FDA stands for Food and Drug Administration, it is responsible for protecting the public health by assuring that foods are

What is the proper role of the following groups in addressing these dilemmas: National governments, Branded pharmaceutical firms, and Generic manufacturers?

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.

A new escalating drug abuse epidemic has come about in the recent years; people are now choosing prescription pills as their new drug of choice. The use, abuse and death caused by prescription drugs has increased significantly within the past couple years. All types of prescription pills are more easily accessible from their doctors, family members or off the street. Doctors are handing out prescriptions for pills, such as pain management pills, muscle relaxers, and anti-anxiety, like they are candy and not potentially dangerous to the consumers. In today’s society doctors are over prescribing pills to Americans and the prescription pill distribution should be more closely monitored and controlled. Although there are people who benefit

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 same country where someone dies from accidental prescription drug overdose every 19 minutes, one must ask what is being done by the FDA to stop this. The answer to this is quite simple. Nothing. In the past thirty years, approximately 90% of all the new drugs approved by the FDA have had little to no advantages over existing drugs on the

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.

In the United States of America, there is prescription drug abuse epidemic that continues to be a growing concern. Prescription drugs cause a large amount of overdoses and result in an abundant amount of deaths each year. A government study conducted shows this epidemic is scarily on the rise, “A recent government study found a 400% increase in prescription drug abuse between 1998 and 2008” (Schreiner 531). The excessive use of prescription drug abuse is leading to nonmedical use of the drugs, and creating addiction. Furthermore society is paying an extreme amount of money in this battle. With this drug abuse on the rise, legislators must create a law preventing doctors and pharmacists from over prescribing prescription medications as well a law to require they both participate in drug monitoring programs to prevent drug abuse. Now is the time that doctors and the pharmaceutical industry must be held accountable for their role in causing one of America’s worst addictions. The over medication of prescription drugs in the United States must be brought to an end by legislators creating laws to stop

* No foreseeable new product in pipeline. Currently takes up to 11,000 compounds to be screened to find one (1) compound to send through final testing (human trials). And even then it’s not guaranteed to make it past the FDA.

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.

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.

Pharmaceutical companies should attempt to be as transparent as possible when marketing prescription drugs to the public. Their marketing efforts should not only convey the benefits of the prescription drug, but also easily convey the possible risks associated with the prescription drugs. Many patients may tend to think the benefits outweigh the potential risks of prescription drugs and may pressure their physician to prescribe it. Due to the way the prescription drug is marketed, the consumer may believe the