Fda Ethical Dilemmas

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.

Review Ethics boards should be considerate of the patient’s they are using to conduct their research by first having them fill out an agreement to participate in the research. This idea is reinforced by a field researcher who had to get the patients to sign permission slips before interviewing them and the research wouldn’t reveal their identity. The field researcher found this was an effective way to make the patients whom the experiment is being conducted on comfortable and willing to participate. It allows the patients to have a say on whether they are willing to have specific research done on them whether related to psychological reasons such as asking questions or to have biological research

Identify and explain two ethical issues/dilemmas in healthcare as identified and discussed in the scholarly literature (ProQuest, EBSCO,

In the long run, these practices will ensure that consumers purchase an effective product that is not dangerous, otherwise, companies may face very serious consequences including recall, seizure, fines, jail time and of course, lost of profit. When the manufacturer believes they are equipped for an inspection, a highly specialized FDA staff examines the pharmaceutical manufacturing facilities and ensures that it is compliant with current Good Manufacturing Practice (cGMP) regulations. Here, the ICHQ7 guidelines, staff responsibilities and training will be discussed followed by how to manage a 483 and close out meeting.

The FDA is responsible for protecting the public health by assuring the safety, effectiveness, quality and security of human and veterinary

The FDA behaves in ways that enhance its reputation for protecting consumer safety and public health. As gauged by public opinion polls, the FDA remains one of the most popular agencies in government, regularly securing 70 percent or greater “approval” of its performance among sampled respondents.5 Buttressing this popularity are powerful symbolic lessons of history: The FDA is widely credited with saving thousands of American lives in its response to the sulfanilamide tragedy of 1937 and the thalidomide scandal of 1959–1961.6 Congress dramatically strengthened pharmaceutical regulations after each of these events. Thereby whether or not the agency deserves it, the FDA clearly possesses a reputation for protecting public health and consumer safety.

A physician has the responsibility to determine the legitimacy of all work injuries and to report its finding accurately. If a physician prepares a report with the intent to use it in support of a fraudulent claim and knowingly submitted for payment under an insurance contract, the physician may be subject to fines or imprisonment and risks the possibility of having his or her medical license revoked. Presenting a claim for an item or services based on a code known to result in greater payment or submit a claim for services not medically needed is a violation of the false claim act.

When it comes to the Guatemalan syphilis experiment and the Tuskegee experiment both were two unique experiments. Recently, the United States apologized last year for the experiment, done in Tuskegee which was meant to test the drug penicillin. However, Two years before that, Health and Human Services Secretary Kathleen Sebelius made an apology for the experiment conducted in Guatemala. With that said, the researcher rejects the case that a utilitarian could make the case that the Guatemalan syphilis study was more ethically defensible than the Tuskegee study, because the Guatemalan study had greater potential to lead to useful medical knowledge that could save many lives, while the Tuskegee study did not have any such potential (Bonnie Steinbock, 2005). I believe that neither experiment was for medical knowledge or served and medicinal purpose and that

The Food and Drug Administration agency, or more commonly referred as the FDA, is a federal agency that takes charge in protecting the public’s health by certifying the safety, efficiency, and security of civilian and veterinary drugs, biological products, and medical technology; in addition to certifying the safety of our country’s food, supply, cosmetics, and productions that involve radiation. Not only does the FDA have that responsibility, but also the regulation of manufacturing, marketing, and distribution. The FDA advances the public health by amplifying innovations that create medical products more effectively, safer, and affordable where civilians can gain access to, all the while receiving science-based information they need to

My initial reaction to this situation is to not advise them to write a prescription for their patient to give to the woman nor would I advise them to visit the woman either. If possible, I would say to that instead the patient could try to convince the woman to visit them or another doctor to examine if she actually needs the drugs for her condition. In this circumstance I consider both the physical, resident, and the woman as the primary decision makers with the patient as the stakeholder. My primary ethical question is whether it is morally permissible to write a prescription for someone who is not your patient and is it right to pay them a visit at their home.

One ethical issue which raised its head a few years ago and has resulted in changes to the way medication is administered was the covert crushing of medications and adding them to jam or other foods to disguise them when an individual declined to take their medication.

Disease has been a factor in human evolution for as long as we have been around. How you to respond and take control of anto the emerging disease has all thewill impact on how the disease will spreads and affect the lives of the human population. Now, what is the responsibility of the CDC or other global health organizations? Furthermore, do are the practices these groups are preformming when responding to appearing diseases need to be ethical? WhoLikewise, what draws the line when trying to develop a response and solution to a possible epidemic? For instance, should we collect biological specimens of the disease for future outbreaks and what is the role and obligation of healthcare workers? All of these questions should we taken into account

Thank you for reading my post and for your insightful comments, it is human nature to protect things and conditions that make us comfortable, however, doing so at the expense of others in the society is unethical or immoral. In my opinion, some people as well as businesses, tend to try and derail public policies that are unfavorable to them through various avenues; avenues such as, the use of Lobbyists to influence policies makers. Furthermore, the self-interest groups’ agendas couple with other bureaucratic issues that are inherent in the public health sectors of the government usually results in longer than necessary time for enacting changes to some public health policies.

For many years, common medical practice meant that physicians made medical decisions for their patients, but this view has gradually been replaced by promoting patient autonomy. Patients are now allowed or enabled to make autonomous decisions about their health care, sharing the decision-making responsibility with the doctors. Still, ethical issues remain today. The top controversial, ethical issues with medical care and cultural or religious beliefs are physician-assisted suicide for terminally-ill patients, abortion, blood transfusions, organ donations, and refusing care altogether based on religious beliefs or on sexual orientation and gender identity. Many patients use their religious beliefs and values to understand, cope, and guide their

Thousands of people voluntarily enroll in clinical drug trials every year. They are putting their health and safety at risk by participating in a drug trial. One would think they would be doing this to promote medical advancement, but in all actuality, it is for the high dollar amounts they receive for compensation. People that frequently enroll in drug trials are often called “guinea pigs.” The monetary amount people are paid can go as high seventy-five hundred dollars. The more invasive the procedure is the higher the compensation. These “Guinea pigs” are required to pay taxes on the money they do make. (Elliott, 2008)