On July 16, 2012, the Food and Drug Administration (FDA) approved the use of Truvada, the first drug approved for reducing the risk of contracting an HIV infection in uninfected individuals ("FDA Approves First Drug for Reducing the Risk of Sexually Acquired HIV Infection"). Truvada is made up of two drugs, emtricitabine and tenofovir, that work by blocking an enzyme called reverse transcriptase, which HIV uses to copy its genetic material in order to reproduce. Truvada has been approved for the treatment of HIV in infected individuals for about ten years. However, scientific experiments have shown that it can be used to protect uninfected people who are at high-risk for acquiring the virus by taking the drug daily, before and after exposure (Costa-Roberts). Extensive research involving Truvada have been conducted over the years but the results have been interpreted differently among the HIV and AIDS society. While the need for a cure or vaccine for HIV is not commonly refuted, the controversy surrounding the daily use of Truvada as a preventive measure against AIDS center around effectiveness and commitment. According a major study, iPrEx, if Truvada is taken daily, it has shown to be up to 99 percent effective (Barro). However, some contemplate on whether or not this finding is more of a statistical estimate that’s based on debatable assumptions, questioning the logos. This study involved men who have sex with other men. This study discovered that men who were
The Drug Enforcement Administration (DEA) is a United States Department of Justice law enforcement agency. Their purposes in law enforcement is to stop the sale of illegal drugs, drug trafficking, investigate major crimes within the United States and internationally, and to secure and protect our communities from ever confronting drugs. DEA also cooperates with many major law enforcement agencies such as federal, state, local, and foreign law enforcement agencies to stop criminals from smuggling drugs in our neighborhoods and help the people from getting involved with drug substance. Other responsibilities include carrying out missions and responsibilities in investigating major crimes, and detain drug
This report is Part 1 of assignment for Marketing MBA 565-MBOL1 to Dr. Stephen Baglione
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.
When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the
6- Which will be the best method for cleaning and sanitizing equipments that cant be placed in dish machine or three compartment
In our experience with Pharmasim we learned that Marketing decision making must be very sensitive and responsive to everything going on in the industry which is very complex. Consumer responses to marketing tactics can be volatile and unpredictable and no idea is guaranteed to work well. Marketing is a matter of meticulous research, assumptions, planning, and volatility at times. Overall we took away two major points: 1) that it is important to consider the product lifecycle in evaluating how to promote businesses and, 2) that the “Sweet Spot” as a competitive advantage should be the greatest point of consideration when evaluating how to best gain leverage to beat the competition in the minds of
The intended use of medications is meant to improve a person’ health, it is very important the individual administering medication or self-medicating use the drugs correctly, by following the doctors’ instruction for the medication prescribed. Medication is given to diagnose, treat, and prevent illness. Medication can be very dangerous, which can potentially cause harm or even deaf if it’s not used properly.
Food and drug administration is a department of U.S health and human services. It’s responsibility is to test the safety and efficacy of new drugs entering the market as well as to make sure that these medicines are quickly accessible to people. The Food, Drug, and Cosmetic Act has been passed in 1938 to ensure that foods other than meat, poultry and fish are clinically hygienic and safe to eat. This act also requires that the food should be labelled according to its content. (FDA.org) Drugs and tobacco are also regulated by FDA and in 1996, FDA strictly regulated the use of tobacco products like nicotine, cigarettes and smokeless tobacco, by children and adolescents because of the increase in diseases prevalence and tobacco addiction. Annually 40000 deaths are attributable to its use and most of them are of premature. Therefore the goal of FDA is to stop the tobacco addiction by minors and prevent the deaths and diseases due to nicotine addiction. (FDA vs Brown, n.d) This essay will cover the food and drug administration’s role in under and over regulating drugs and medicines and how it effects our economy, health care system and patients health and safety.
Specify the types of country risks that pharmaceutical firms face in international business. How do the political and legal systems of countries affect the global pharmaceutical industry?
At the turn of the century America entered a new age that many historians call the Progressive Era. During this time period, the American Political system changed its view on how America should be brought about. It provided a purification of the American government through direct democracy. This era included many social and political reforms, which were brought about due to monopolies, and trust corporations.
Dead rats, infection diseases, and poison. These are only a few of the absolutely horrid things that would carelessly be thrown in by factory workers during the making and packaging process in the 1900s. People of that time period were completely unaware of how uncared for the meat that they were eating every day really was. Their food wasn’t cared for the way ours is today and it definitely wasn't inspected, therefore ending up with that unwanted rat chunk in your meat. The Food and Drug Act and the Meat Inspection Act of 1906 really shaped the cycle our food before it hits stores today compared to the 1900s, by making it a law to have all equipment cleaned correctly, including the food, and making sure all food gets inspected before it goes to the mouths of buyers like you and me.
The Controlled Substances Act (CSA) gives certain bodies or individuals such as research scientists, pharmacies, doctors and manufacturers the legal right to access controlled substances.
When the HIV virus was identified in the 1980’s, many companies began to search for an antiviral drug but Burroughs Wellcome led the research effort. There were three drugs being tested by other companies as well including, AZT by Burroughs Wellcome, DDI by Bristol Myers and DDC by Hoffman-LaRoche. These drugs inhibit reproduction of HIV and slow the damage it causes.
“Helping people on their path to better health” is a quote used by CVSHealth, I first heard it during the orientation for my pharmacy technician job. I love this quote because it really defines my purpose for wanting to be a pharmacist in the simplest way. My journey to becoming a pharmacists consist of why I selected pharmacy as a career, future goals, and my backgrounds that will help me achieve the goals that I set for myself.
Today in the 21st century the roles of pharmacist have expanded tremendously. Before pharmacist had the role of solely dispensing drugs. Pharmacists were limited to only being regulatory or clinical pharmacist. Back then they were called medical purveyors who were much like today’s regulatory pharmacist and hospital pharmacist who are similar to hospital pharmacist. Now pharmacists carry many roles in healthcare. Pharmacist can play roles in public health, community, health systems, state, and federal government.