Ethical Issues Surrounding The Orphan Drug Act

The amount that a mother will incur to have her bundle of joy will depend on many different factors. One may take into consideration where you live, whether there are any complications and whether mommy has a vaginal birth or a C-section. But just to take a glimpse inside this world, here are a few figures that may surprise you. For prenatal care and delivery, the cost in some areas can range from about $9,000 to over $250,000 (Alfieri, 2012), which is quite a wide range, if not more. This is without the privilege of having insurance to cover. Even with the privilege of having health insurance, the majority of these expenses could be covered, but that’s not always the case. It

Imagine this: you are tragically diagnosed with a chronic life-threatening illness. Your only hope to survive is through medication to treat your disorder. The medicine is pricy but you can work out the costs each month. One day, you go to fill your prescriptions and realize the cost of a $13 pill has jumped to an astounding $750. You need this patented medication to survive and to afford it you end up losing your home, filing for bankruptcy, and sleeping in your car. This story sounds fictional but it is the reality for many Americans who can no longer afford their grossly overpriced medications.

I imagine that consumers would start to compare $150 a month to other things they pay $150 for: a week of groceries, a cell phone bill, a cable & internet bill, gas, etc. They may have hard time justifying the value of the drug at this price point and opt for a lower priced alternative, whether it’s Alli or a gym membership.

"In the past two decades or so, health care has been commercialized as never before, and professionalism in medicine seems to be giving way to entrepreneurialism," commented Arnold S. Relman, professor of medicine and social medicine at Harvard Medical School (Wekesser 66). This statement may have a great deal of bearing on reality. The tangled knot of insurers, physicians, drug companies, and hospitals that we call our health system are not as unselfish and focused on the patients' needs as people would like to think. Pharmaceutical companies are particularly ruthless, many of them spending millions of dollars per year to convince doctors to prescribe their drugs and to convince consumers that their specific brand of drug is needed in

The Toxic Substance Control Act (TSCA) is a federal statute that was enacted in 1976. Under the TSCA, chemicals must meet regulations set by the administering body, the Environmental Protection Agency (EPA). The Toxic Substance Control Act also requires testing of new chemicals to determine how they affect both the environment and humans. If the chemicals do not meet the regulations, the EPA is allowed to limit or prohibit their manufacturing and sales (Cheeseman, Page 523). While the Toxic Substance Control Act has been around since 1976, it has been amended or expanded 29 times in the last three years alone (EPA.gov). Violating this federal statute can result in hefty fines, and in serious cases, jail time. Like many federal statutes, the Toxic Substance Control Act has some opposition, especially as more changes continue to be made, but overall it has been well-received as a vital protection law that is generally well-enforced.

This topic is important because I stated before there are other human beings out there that are dying and instead of getting the treatment they need they are forced to live with the disease until they die, and pharmaceutical companies are now charging an arm and a leg. Take the medication Daraprim, a medication that is given to AIDs patients it used to cost a dollar a pill something that most individuals could pay, that was until 2010 when the company CorePharma bought the rights and started charging 13.50 a pill. (CNN Money) This amount is still semi reasonable for individuals in America, while those in Africa well if they couldn’t pay for it before then they certainly won’t be able to buy it now. (CNN Money) CorePharma was once lead by Martin Shkreli the man who is now awaiting sentencing because he was charged with fraud and conspiracy (Business Insider). This same man raised the medication again from thirteen dollars and fifteen cents up to seven hundred fifty dollars a pill, that is a five-hundred percent increase. (CNN Money). They then dropped the price in half so now pill costs

This drug which costs a little of $115 per treatment; coupled with the record number of drug shortages in the United States is problematic.

According to the U.S Department of Health and Human Services, the Affordable care Act from President Obama gives consumers more options and benefits when seeking coverage from insurance company. It offers lowering cost as well as gets more access to high quality of care. This law creates Patient’s Bill of Rights that is very effective to protect consumers from any abuses or fraud from insurance company. Some preventive services are available to many Americans especially Medicare recipients at no cost. Not just that, they also receive a special offer of 50 percent discount for any well-known drugs in the market place under Medicare named “donut hole.” The Affordable Care Act helps other organizations and programs to convince healthcare providers

The Pure Food and Drug Act and the Meat Inspection Act are congressional acts that were signed by President Teddy Roosevelt on June 30, 1906 in an effort to prevent the adulteration and misbranding of products distributed. During the eighteenth and nineteenth centuries, America was in the process of transforming from an agrarian society to an industrial economy which became known as the Progressive Era. During this period, meatpacking industries and food corporations were run by corrupt business owners who overworked employees in unsanitary conditions, and had no regulation of how the food was processed. As a result of the high demand for food in the United States, food industries were under the impression of mass producing goods to create

Insurance companies and health care providers have several methods of controlling prices and making profits. The ACA makes efforts to restrict the high costs of health care through new limits on out of pocket costs, removal of life time limits in insurance companies, and placing restrictions on denial of coverage to enrollees with preexisting conditions. The lifetime limits and high out of pocket costs are ways for insurance agencies to spend less money on their beneficiaries. By restricting access to care for those with preexisting conditions, they limit the amount they need to spend on expensive treatments for patients with conditions such as cancer and HIV which can cost companies millions of dollars. These changes will grant care to those that need it the most. In addition to controlling the cost of services provided to enrollees, there will also be changes in prices for insurance itself. The law establishes insurance exchanges that will help regulate the premiums for insurance by keeping companies and their rates

According to Miller, Benjamin, and North, “FDA bureaucrats decide whether or not new medicines (prescription drugs) should be allowed to go on sale in the United States” (Miller, Benjamin, and North, page 3). Prior to the 1962 Kefauver-Harris Amendments being made to the 1938 Food, Drug, and Cosmetic Act, the FDA was given a limited time frame of 180 days to approve or deny a new drug application. These amendments added a new “proof of efficacy” requirement and removed the 180-day time constraint, allowing the FDA to demand whatever

Nurses are subject to a plethora of legal, ethical, and professional duties which can be very challenging on a day to day basis. Some of these duties include respecting a patient 's confidentiality and autonomy, and to recognize the duty of care that is owed to all patients. As nurses our duties are always professional; however there are legal implications if these duties are breached. We also must consider when it is okay as nurses to breach these duties and therefore ethical issues arise. As nurses one of our main priorities is to advocate for our patients, without our own personal feelings on the matter taking over.

In the United States, a drug can only be advertised legally after being approved by the Food and Drug Administration (FDA). Once attaining at least one FDA-approved use, physicians can prescribe a drug for other unapproved uses, based on their clinical judgment; this is referred to as “off-label use” (McCambridge, 2008). In general, marketing drugs for off-label uses is illegal; however, pharmaceutical companies have gone to various lengths within their legal rights to accomplish exactly that.

This case study focuses Burroughs Wellcome and their drug Retrovir. Retrovir is a drug that treats AIDS and AID-related complications. In 1987, Burroughs Wellcome obtained approval from the FDA to market azidothymidine (AZT), also known as Retrovir, as a treatment for AIDS. Retrovir was the only kind of drug on the market. Because of this, many critics accused Burroughs Wellcome of price-gouging, as the price of Retrovir was $188 for a hundred 100mg capsules sold to wholesalers. The president of Burroughs Wellcome, T.E Haigler, defended the high price, stating it was due to uncertainty in the market, the possibility of new drug therapies, and profit margins created by new drugs. Even though Retrovir’s price was dropped 20 percent in December 1987, and 20 percent more in September 1989, due to the House of Representatives launching an investigation, there was still pressure to lower the price. The big question faced in this case is what is Burroughs Wellcome’s next move regarding pricing?

Hospitals buy crucial heart medicines, like Nitropress and Isuprel, for a great deal of money, therefore when a patient needs this medicine, the high price is passed down to the patient. With the price of these two drugs increasing, patients are having to pay more for their treatment. In 2015, the price for Nitropress, a drug used for emergency blood-pressure, has been increasing from $215 a vial to over $881. In addition to the price of Nitropress increasing, the price for Isuprel is too. Isuprel is a drug that treats abnormal heart rhythms, and the price has increased from $180 to $1,472 a vial. Obviously, raising the price this much does not help patients that are already paying expensive hospital bills. Paying expensive medical bills can put patients in money trouble, and adding the cost of vital medication to their health puts more of a burden on them.