Halloween 2004: Six year old Austin O’Toole received a Snickers Bar, which he devoured in one large bight. Immediately, he began to feel tingling in his lips and a lump in his throat, strangling the air from his lungs. Within minutes, he passed out. Austin awoke hours later in the hospital after suffering anaphylactic shock triggered by an allergic reaction to peanuts. To avert another anaphylaxis attack, Austin always carries an epinephrine injector, which is commonly referred to as an EpiPen. An epinephrine syringe injects adrenaline, a chemical, which thins blood and opens up air passages into the lungs. EpiPen had a longtime monopoly on the epinephrine injector market, but its monopoly recently ended. The EpiPen market failure was produced by inconsistent Food and Drug Administration regulations, which restricted potential competitors from entering the market, causing EpiPen to have a monopoly on the epinephrine injector market. To address the market failure and prevent EpiPen from abusing its monopoly power by raising prices, Congress passed the Combination Product Regulatory Fairness Act, facilitating the FDA combination drug approval process. The bill has resulted in more competitors entering the market, ending EpiPen’s monopoly and forcing EpiPen to offer a more affordable product.
Epipen had a monopoly that was created by the FDA failing to have a consistent product approval process. A monopoly is a set of circumstances where one producer controls the supply of
In period five, we introduced the line extension Allright; a 12-Hr muli-symptom relief capsule. We decided this extension would be successful, as the allergy market is very small and had an entrenched competitor. Therefore, while we were aware of potential cannibalization, we believed that the targeted market (retirees, empty nesters, and young singles) would have sufficient demand for our product. We also reasoned that this target was far enough removed from Allround’s to gain additional market share without taking any from Allround. However, this was not the case, as cannibalization was a pressing issue. Market share was gained at the expense of Allround.
The pharmaceutical industry is one of the most powerful and greedy industries in our country, with a goal to make as large a profit as possible, at the expense of the sick.
Pharmaceutical companies are provided with temporary monopoly rights on the production of new drugs which result in a higher cost on consumers. If competing companies were allowed to produce generic forms of those drugs, consumers will be able to afford those medications even in cases where those consumers have no insurance coverage. The company responsible for developing and inventing the original medication could be offered incentives to invent in the future by either obtaining tax breaks or NIH funding for future research. They could even be offered a percentage of the sales of the generic drugs. Economist Gary S. Becker advocates dropping many FDA requirements that, in his opinion, provide no additional safety measures but rather delay the development of new drugs.[12] Betamethasone, for example, has been part of the standard prenatal care in Europe since the late 1970’s while it got adopted in the U.S. after 1997. On many occasions, the FDA ignores all scientific evidence concerning certain drugs because the manufacturer did not follow their mandated bureaucratic standards.
They have also attacked patent listings in the Food and Drug Administration “Orange Book” and have alleged monopolization through fraud on the Patent and Trademark Office and sham litigation. Yet other cases have condemned distribution agreements as unlawful exclusive dealing. These government actions have led to substantial private class action litigation against the pharmaceutical industry. The FTC has also challenged numerous mergers and acquisitions in the industry over the last decade. One common feature in all of these cases is the need to define a relevant market. In nonmerger cases, the FTC and private plaintiffsgenerally allege narrow markets, limited to a single drug and its generic equivalent in some cases and to generic drugs excluding the bioequivalent “brand-name” drug in other cases. In its merger challenges, on the other hand, the FTC has alleged markets ranging from those based upon a particular chemical compound, to broader markets based upon various drugs’ manner of interaction or dosage form, to still broader markets of all drugs used to treat a disease or condition. In numerous pharmaceutical merger challenges, the government has included in the market not only currently marketed drugs but also other drugs under development, alleging “innovation markets.”
The current debate over the Mylan Company’s near monopoly of the epinephrine market through its EpiPen shows what can happen without monopoly regulation. While the cost to produce an Epipen is around $30, the price to the consumer is around $300 each. The economic implications for a family that needs to keep the device on hand to save a life can be excessively high, the emotional results of not having one when you need one are debilitating. This monopoly is further enhanced by state-enforced regulations requiring that schools keep EpiPens in stock and the, so-called, EpiPen law enacted in 2013, which leave little incentive for other pharmaceutical companies to develop their own technology for fast-acting emergency devices. (Bartolone, 2016) Breaking Mylan’s monopoly will not only lead to new product development but lower prices for consumers for a life-saving delivery
The twenty-first century has seen pharmaceutical companies grow in unprecedented size and strength. Due to the unprecedented growth the larger pharmaceutical companies have gained leverage and power in the prescription drug industry, but they lack innovation to market and they seek ways to help the business continue to increase its profits. The pharmaceutical industry was once ethically sound and was a valuable player in the development of human health. However, overtime with the lack of innovation pharmaceutical companies are becoming an unethical market that exploits patients, doctors and anyone else it can to increase its profitability. With eyes only on profitability this can create a hazard for patients because there
Prescription drug prices are on the rise in the United States. Currently, the United States does not implement a price control on prescription drugs. Every day the supply and demand for prescription drugs fluctuates. Pharmaceutical companies produce drugs that are necessary for survival. Therefore, it is necessary for research and development to continue in the United States. Those suffering the effects of exorbitant prices must do so until a generic form of a prescription drug is produced. Once approved by the FDA, new drugs will make their appearance on the market and patients will no longer suffer financially. Until then, it is necessary for pharmaceutical companies to price their drugs based on the idea of supply and demand. This produces the profit used to fund research. Price controls discourage innovation. If a price control were set in place, of course the price of prescription drugs would decrease. However, the development of new drugs decreases with it. Today’s generation would benefit from lower prices, while future generations would suffer from the loss of drug innovation.
When J&J realized that their Tylenol capsules caused the deaths of four Chicagoans, they immediately initiated a recall of all Tylenol products, and spread the news by any means possible. Cars with sirens and loudspeakers drove through the city and suburbs of Chicago, urging residents to throw away any Tylenol capsules they might have. Schools were contacted, and they instructed students to bring all Tylenol products to the school nurse. News flashes were initiated to warn people of the Tylenol danger as well, and all stores were instructed to remove Tylenol products from their shelves. Removing the products was a gutsy move, not only because it was dangerous to the company by recalling so much products, but there was also a fear that the killer
In the article “Mylan Faces Scrutiny Over Epipen Increases,” by Jonathan D. Rockoff, the product of EpiPen is discussed, along with Mylan’s incentive to increase price, and the public and governmental backlash to this price increase. EpiPen is a lifesaving, emergency, allergy treatment that keeps those who have extreme allergic reactions from going into severe shock. It is used by millions of people, including many schoolchildren. A pack of two costs $608.61, which is up 548% since 2007, as the product has had 17 price increases over the years, according to Truven Health Analytics. Over 3.6 million prescriptions for the product were written last year, according to IMS Health.
In 2007, the Mylan pharmaceutical company purchased the rights to the EpiPen. The drug inside the EpiPen is Epinephrine, which is a synthetic adrenaline that is used to treat possible anaphylaxis shock caused by allergies. “Evidence-based guidelines recommend the prompt administration of epinephrine as first-line treatment for an anaphylactic episode” (Dinakar, 2012). Millions depend on carrying the drug to live a normal life. Currently the EpiPen has no
Recently, there had been a controversy over the rise in pharmaceutical costs involving the EpiPen in the United States. The EpiPen, also known as adrenaline/epinephrine, is a widely used injection that is used to treat allergic reactions. This generic drug has been available for many years. The EpiPen controversy is a prime example of how monopoly
* Monopoly Power. Pharmacists often face questions from patients regarding how prices of medications are determined and why, in some cases, they are so expensive. Unlike markets for other goods, in the pharmaceutical marketplace there are a limited number of manufacturers and the medication being sold are not identical, but rather are differentiated. There is a guarantee via patent protection that no potential competitor may manufacture an identical drug and sell it at a lower price in the short run. As a result, the branded manufacturer is able to make profits. Since there is only one seller, the monopolist determines the price of the medicine. This establishes the monopolist as a price setter, permitting prices above the perfectly competitive price by controlling the quantity of medication produced in the marketplace. This is in stark contrast to being a price taker, and accepting a price established within a perfectly competitive marketplace. The end result is that prices are higher under these market conditions than they would be in a purely competitive marketplace.
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.
While this case is literally full of negative aspects, we will only focus on the main points for both arguments. Pharmaceutical companies want to be sure that the products they spend years and millions of dollars to create are not easily reproduced and sold at discount prices. The profits pharmaceuticals make of their patented products are supposed to refinance new research. So taking away their exclusive distribution rights and allowing other manufacturers to just copy the product and sell it at
There were two important developments in the 1970s which further shaped the industry in the form that we see today. Firstly, the Thalidomide tragedy (where an antiemetic given for morning sickness caused birth defects) led to much tighter regulatory controls on clinical trials, greatly increasing development costs. Secondly, enactment of legislation to set a fixed period on patent protection (typically 20 years from initial filing as a research discovery) led to the appearance of “generic” medicines. Generics medicines are those that have exactly the same active ingredients as the original brand, and compete on price.