The Pros And Cons Of Generic Medicine

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

Six basic types of ingredients used to formulate OTC brands. Each ingredient targets one of five basic symptoms.

Medication has also become increasingly complex. There has been a massive increase in the number and variety of medications available. In addition, many medications have different routes of delivery, variable actions (long acting, short

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

Another thing that the CDER is responsible for doing is approving generic drugs. A generic drug product is one that is comparable to an original drug product and is identified in the FDA's list of approved drug products with therapeutic equivalence evaluations. They are comparable in dosage form, strength, route of administration, quality, performance characteristics and intended use. A term to be familiar with concerning generic drugs is "ANDA."

The difference is that listed drugs are going to be covered when prescribed. Non-formulary drugs will need prior authorization to be covered. You may not be able to get prior authorization. Very often, drugs are included on the list due to having characteristics that make them cost effective. Although low cost is one pertinent characteristic, it is not the only one.

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.

Medicine can help prevent disease, manage pain, fight pathogens, and manage chronic conditions. The Food and Drug Administration frequently documents information about different medicines to ensure that they are safe for people to take. Prescription medicines are drugs that a doctor has to write permission for you to get because they are to treat a specific problem. Over the counter medicines are ones that you can buy at the store because they have been found safe by the FDA. Medicine abused occurs when someone uses the drug for something other than its intended purpose. Abusing medicine is very

The Food and Drug Administration (FDA) is responsible for protecting and promoting public health through regulating pharmaceutical drugs, biologics and medical device in context to granting approvals for marketing authorization, surveillance of the clinical trial study of the drug, post-marketing surveillance of the medical product, etc. The Pharmaceutical companies seek for FDA approval for a new drug to be marketed through a long process. This process starts with applying an application known as an investigational new drug application (IND) to start clinical trials to enroll a group of patients believed to benefit from the investigational product, and to approve that drug is safe effective.

Metoformin is a medication used to treat Type 2 diabetes. Metformin is classified as a biguanide and antidiabetic medication. Its therapeutic classification is an antihyperglycemic. Metformin, which is the drug’s generic name, is also known under its trade names: Fortamet, Glucophage, Glucophage XR, Glumetza and Riomet. Metformin is an oral hypoglycemic medication and has three main actions: Metofrmin increases the binding of insulin to insulin receptors in skeletal muscles and fat, which works to improve tissue sensitivity to insulin. Through this action, glucose is able to be transported into skeletal muscles and fat and the body is able to use glucose to function properly. Metformin also suppresses gluconeogenesis, which is the production of glucose from non-carbohydrate sources such as fat and protein. Metformin also prevents the liver from converting stored glycogen into glucose. All these actions work together to lower the level of blood sugar and also lower the Hemoglobin A1C value, ensuring diabetics have better control of their blood sugar.

The U.S. Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services that is responsible for assuring the safety, efficiency, and quality of drugs and vaccines. In America a drug must first be evaluated by the Center for Drug Evaluation and Research (CDER), which is a division of the FDA, before it gets approved for sale. This means that the department must make sure that the medicine been evaluated works properly and that its health benefits are greater than its identified risks. A company or a sponsor that is introducing the new drug initially performs a laboratory and animal tests to determine the safety and the effectiveness of the drug in humans. Once this step is successfully completed, several tests are implemented in people to confirm that the drug is safe when used to treat a disease and whether it provides a real health benefit. Finally, results of the tests that prove the safety and the effectiveness of the treatment are sent to the CDER. After a group of experts at CDER reviews the submitted evidence and ensures that the medicine's health benefits surpass its known risks, the drug can then be sold around the US (Development & Approval Process (Drugs), 2014).

This article fits nicely with our current topic, The Bureaucracy, because it demonstrates the power of the Executive Cabinet. The FDA, which resides under the Health and Human Services department, has the ability to discern between what products can be released for general consumption and, as a brief analysis of its role, ultimately determines whether a product can be sold.

In the U.S., the Patient Protection and Affordable Care Act, authorized the FDA to approve generic versions of biologic drugs and grant drug manufacturers 12 years of exclusive use before generics can be developed. The FDA law offers PharmaCARE a 180 day exclusivity period to generic drug manufacturers in specific cases. Only one generic manufacturer can produce the generic version of a drug during the exclusivity period. This exclusivity period is only used when a generic manufacturer argues that a patent is invalid or is not violated in the generic production of a drug, and the period acts as a reward for the generic manufacturer who is willing to risk liability in court and the cost of patent court litigation. There is often contention around

In order for this to be possible, manufacturers have to make sure that the generic medication has the same ingredients as the brand name. The factors that can differentiate are the color, shape, and taste of the medication. Manufacturers are required to send in additional paperwork to the FDA to show that they are in accordance with good manufacturing practices (SA website, 2). Also, the generic medication must be able to dissolve in a beaker at the same rate as the brand-name. All things considered, as long as the medication passes all of the equivalency tests, it can be sold and prescribed to individuals who need it. Another difference between these two are if the drug is still under patent protection by the main manufacturer. When a company develops a new drug, it receives a patent that lasts about twenty years (SA website, 4). Other companies cannot sell the patented product without permission or until it expires. Not only does manufacturing factors affect how society looks at these medications, but price is what is grabbing the bull by the

“Historically, generic drugs have long been considered a vital weapon in the fight to contain soaring health care costs. But in the past years, the price of many generics is disconcertingly moving in the wrong direction, drawing the attention of Congress and pricing the wallets of consumers as well as pharmacies and insurers” (Hirst). Generic drugs were introduced to help combat the rising cost of health care and allow market competition for the brand-name drug. However lately, the price has been increased. Due to big corporations wanting more profit, raw material shortages, and insurance not covering the medical bills the prices have