Food and Drug Administration

A man’s wife is dying of cancer and there is one medicine that can save her. This drug rare as it is only made by one chemist, and as a result, the price is exorbitant, ten times the actual cost of production. The man cannot afford to pay it and must either forgo the chance to save his wife’s life, or undertake desperate measures. Now, this scenario could be viewed as Heinz Dilemma, a story often told in order to gauge the levels of moral reasoning, but unfortunately, it could also serve as an…

First of all, I belong to a drug safety division in a pharmaceutical company, and therefore this case study was very interesting. As a matter of fact, a drug safety division is often said to be Pharmacovigilance (PV) division in the pharmaceutical industry. According to the World Health Organization (WHO), "Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.…

potential. This Act made these drugs illegal to use. When deciding whether to…

The pharmaceutical and medications industry regarding the amount of time and money invested in developing new drugs is one of the fastest growing industries in the United States. There are always a lot of researches, developments, and productions of new drugs in the industry of pharmaceutical; however, patients are able to find or get the medications either over the counter in a retail stores, pharmacies, and many other medical markets or by prescriptions. Consequently, medication usage is to…

Historians have referred the 1920’s as “The Roaring Twenties,” the “Jazz Age,” and the “Age of Normalcy.” Each of these labels imply different things. America in the 1920’s had a very diverse population. With a diverse population comes variegated cultural, social, political, and economic differences. However, these differences created a unified theme. The theme was change. There were political, consumer, social, and cultural changes in America through the 1920’s that exemplified this theme. The…

In the field of biomedical research there many imperative careers that work together to reach a desired conclusion. One of these careers is a regulatory affairs specialist. Regulatory affairs specialists are a crucial part in ensuring that a client’s product meets the standards set up by various governments. Regulatory affairs specialists are needed in many biomedical industries, one of which is the pharmaceutical industry. A regulatory affairs specialist in the pharmaceutical industry has…

The peer-reviewed article, EpiPen price hikes comes under scrutiny, by Rita Rubin reports the out lash towards the drug company Mylan and CEO of Mylan Pharmaceuticals, Heather Bresch, during recent years due to the increased price of EpiPen. “… since the drug company Mylan acquired EpiPen in 2007, its price has soared more than 400%, to just over US$600.” For many Americans, the fear of losing a loved one simply because they can no longer afford the medication is very real, as according to the…

The mission of the Drug Enforcement Administration (DEA) is to “enforce the controlled substances laws and regulations of the United States” (The United States Drug Enforcement Administration, 2017). The DEA received it legal authority from the Comprehensive Drug Abuse Prevention and Control Act of 1970, usually termed the Controlled Substance Act (CSA) (The United States Drug Enforcement Administration, 2010). The DEA classifies drugs into groups of “schedules” represented by Roman Numerals…

elevated drug costs via increasing premiums (“The high prices of prescription drugs,” n.d.). Digging deeper in the mindset of the drug companies, they exploit the blend of regulations that oblige insurance companies to incorporate fundamentally all of the costly medications in their policies (“The high prices of prescription drugs,” n.d.). They also use the logic and mantra that really stipulates that each novel health care good be accessible to the masses (“The high prices of prescription…

The cost of drugs in America have been increasing despite criticism from the population and public officials. The price for name brand drugs have raised 12% and pharmaceutical companies continue to increase the prices multiple times a year (Thomas, 2016). Pharmaceutical companies have profited on the price increases while insurers and employers pay more. The burden of the high drug prices is often seen first-hand by uninsured patients who pay the list price of the drug. What justifies the high…