The cost of medication in the United States can be very expensive. Finding ways to cut costs is important and necessary to many Americans. Buying generic instead of brand-name drugs is one way to save money. However, not all generic drugs are equal to their brand-name counterpart. Generic Drugs According to the Food and Drug Administration (FDA), 158 billion dollars was saved by Americans in 2010 simply by purchasing FDA-approved generic drugs instead of brand-name drugs. At that time, generic drugs cost on average 80-85% less than the brand-name medication with eight out ten prescriptions being filled with generic drugs. The reason generic drugs are less expensive than their brand-name counterpart is because the FDA does not require the manufacturers to repeat clinical trials for safety and efficacy and these drugs are typically not advertised, marketed, or promoted (Food and Drug Administration, 2013). Generic drugs must be equal to the brand-name drug. The FDA requires generic drugs to contain the same active ingredient, the dosage form must be identical, strength must be the same, and route of administration must be the same as the brand-name drug in order to obtain FDA approval (Food and Drug Administration, 2013). The manufacturer must also prove the generic drug delivers the same amount of the active ingredient as the brand-name drug. This bioequivalence assists in drawing the conclusion that the generic and brand-name drug will produce therapeutic results that are very similar (Food and Drug Administration, 2012). Bioequivalence Studies The FDA-required bioequivalence studies typically are conducted on a small group of healthy individuals. These studies do not use individuals that have been diagnosed with the condition the medication is used to treat. Therefore, age and disease-related factors and patient-related variables are not taken into account. Also, these studies are only single-dose studies which do not take into account the cumulative effects of dosing (Johnston, Stafylas, & Stergiou, 2010). Recommendations are made by the FDA on bioequivalence using ratings. If the FDA rates a generic with an “A”, this means the generic and brand-name drug are interchangeable. A “B” rating translates to not recommending a substitution with the generic drug (Barrett, 2010). In a recent review by the FDA in more than 270 generic drugs, the average difference between the generic and brand-name counterpart was 3.5%. This percentage is very similar to what is expected and found between batches of brand-name drugs (Food and Drug Administration, 2012).
It is not hard to obtain the same drugs from different sources so the customer loyalty is virtually non-existent and the pharmacies have to try extremely hard to sustain their consumer base.
Perusing warning letters in FDA’s Electronic Reading Room yields a plethora of violations regarding adulterated, misbranded or falsely claimed benefits of drugs and supplements. These three issues, consequently, constitute stumbling blocks in drug development or approval and additionally, perhaps also indicate a wanton disregard of compliance in manufacturing and marketing. Do the responsible companies prioritize compliant procedures and documentation? Through investigating three of the most commonly cited reasons for FDA 483 letters, applying them to the above violations, and exploring a culture of compliance, some rationale for causes in this case may be determined.
Why do consumers purchase specific drugs for various ailments, sicknesses or diseases they might have? Why do physicians prescribe certain drugs over competitive drugs that may be available to the public? Why is it that most of us can easily name specific drugs that fit the many ailments of today’s society? On the surface the answer might be as simple as good TV advertising or radio commercials or even internet adds. The truth of matter is the major pharmaceutical manufacturers own the patents on these drugs and this gives them all of the marketing budget and muscle they need to promote the drug and control the pricing. The incentives for larger pharmaceutical companies are very enticing and as a result, they don’t mind spending the time in clinical trials and patent courts to get their drugs approved. Some will even get patents on the process by which the drug is manufactured, ensuring that no competitor can steal the drug or the process. This protects their large financial investment and nearly guarantees a large return for their investors. Many consumer rights groups claim this is nothing more than legalizing monopolies for the biggest manufacturers.
both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling
No matter what type of coverage you have, you are going to save money on your health insurance if you always opt for generic drugs. Experts agree that generic versions are identical to brand names in their effectiveness, and are typically widely
Why are the prices so high? Some critics of the drug companies argue that the larger firms are ripping off the American public, are dishonest and, in some cases, unsafe. On the other hand, there are health care workers such as doctors and their supporters who claim that research and testing for drugs costs money. This supposedly justifies their prices for their products. Also, as an argument to their side, they say that their practice is a benefit to the improvement to mankind. It is a life saving business, but are these prices justified? As one can see, this is a very important issue in medicine today. It affects everyone involved with medicine, which is much of the American public. It also affects the physicians and drug makers.
Every year a large number of new medicines receive marketing authorisation. It is the National Health Service (NHS) responsibility to decide whether the additional cost of purchasing these medicines is justified by the likely benefit to patients. For this reason, a multi-disciplinary activity known as the health technology assessment (HTA) has been created. In the UK, HTA mainly focuses on the clinical and cost-effectiveness of new medicines.
Turner, B. J., Newschaffer, C. J., Zhang, D., Fanning, T., & Hauck, W. W. (1999). Translating clinical trial results into practice. Annals of Internal Medicine, 130(12), 979-986.
...s affect a person’s response to drugs) data are needed. This information will help identify medications that benefit populations in all parts of the world and will better enable local regulators to interpret the relevance of trial results from other countries for their target populations. In the long-term, solutions to problems arising from outsourcing clinical trials will require input from collaborators in academia, industry, and regulatory agencies around the world. The future of the pharmaceutical industries depends on addressing these issues. The ethical and scientific integrity of clinical research globally must be ensured, promote organization and uniformity in the field of international research, and provide information about the benefits and risks of new drugs in the populations and environments in which patients live, wherever they may be.
The rise in cost of prescription drugs affects all sectors of the health care industry, including private insurers, public programs, and patients. Spending on prescription drugs continues to be an important health care concern, particularly in light of rising pharmaceutical costs and the aging population. Prescription drugs have grown to become an essential component of health care. For millions of Americans, prescription drugs are necessary to their health and ability to function in society. While prescriptions are a relatively small portion of overall health spending, they are a main reason for certain health spending trends, growing almost twice as fast all other health services in recent years. Prescription costs can be the costliest expense in your budget, especially if you are on a fixed income. The wealthy can easily afford their medications, but for an increasing population such as the elderly, choosing among purchasing medication, paying bills, or buying food is a real concern.
An EpiPen is a lifesaver for individuals who have anaphylactic or allergic reactions to materials because it provides a strong, respective dose of epinephrine to adults and children. In recent news, Mylan Inc has raised the price of EpiPens to a little of $600. At first glance, I thought that the motive behind this price hike was so increase the flow of revenues for the company. Many opponents of this price hike also have a similar view. They feel that this price hike is dangerous for consumers because there are no generic products similar to the EpiPen. This monopolistic approach has raised questions as to how drugs should be sold in America. In response to the negativity received because of their price jack, Mylan has announced a coupon system that may cover up to $300 of the cost of
In addition to this, pharmaceutical companies can also regulate the price of the drug as they will be the only company selling that drug. However, these aspects of patents can adversely affect the generics industry. The generics industry cannot make or sell drugs that are patented but once a patent licence expires, both the generics industry and the WHO see increased benefits as drugs become more widely available around the world (i.e. developing countries) at a lower price. Here we will discuss the pros and cons of patents from the point of view of the pharmaceutical industry, the generics industry and the WHO. As we said above, patents grant exclusive rights to an invention or a process of making and invention.
For commodity generic drugs, Teva has an opportunity to expand its core business into emerging markets, but there it will have to face institutional voids because such markets are driven by physicians and both physician and other people are not aware about the effectiveness of generic drugs. To cope with the challenge of institutional voids Teva have to look for some competent small pharmaceutical firms for acquisition and some big firms for the joint venture. For changing the perceptions of people and physicians, Teva will require to run marketing campaigns and direct approaches to physicians to develop a market for their products.
The United States is spending way more than any other developed country in the drug marketplace despite provisions made by Medicare through the Affordable Care Act. President Donald Trump is trying to fulfill his campaign promise of breaking monopolies created by multinational drug companies by setting a benchmark and creating policies that would drastically reduce the costs of prescription drugs in the United States. Shady pricing and removal of low-cost drugs from reaching the low-income patients who are uninsured have made prescription drugs unaffordable for them. These drugs are deliberately kept out of the market by multinational pharmaceutical companies in order to drive up monopolies and ending up causing the U.S a lot of
In order for the FDA to approve a drug it has to go through phases. The supporter has to test the new drug on animals. Various species are used to get information on the safety of the drug being researched. Next the sponsor of the drug, submits an application to the FDA based on the result of the initial testing, which includes the drug’s structure and manufacturing, and creates a plan to test the drug on humans. Phase one is all about the safety of the drug, the side effects, as well as how the drug is digested and expelled. In phase two, the patients that are used is for effectiveness. The aim is to obtain data to see whether the drugs work on people with certain conditions or diseases. Therefore, patients receiving the drug, are compared