The Pros And Cons Of The FDA

Words: 1146
Pages: 5
Open Document
According to its mission statement, the FDA is responsible for“protecting public health by assuring the safety, efficacy, and security of human. Specially, after the well-known Thalidomide tragedy in Europe. Based on (21 U.S.C. section 331) the Food, Drug, and Cosmetic Act (FDCA) prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of drugs that lack FDA approval, whether for personal use or otherwise, violates the Act. As a result, the importation of unapproved medications from outside the U.S. is prohibited. Overall, the FDA regulates more than $2 trillion worth of consumer goods, which is no small task. The FDA is keenly aware that it cannot provide adequate assurance that drug products …show more content…
Based on this incident, Sally who is a patient with liver cancer, she has been given 6 months to live. She started to search for any promising treatment which would give her hope to live more and improve her condition. She has been advised to start a medication which is manufactured in Europe and not approved by the FDA. Based on the previously mentioned incident, she has the right to get the FDA approval to import the required medication to treat her condition. Also, based on The Regulation Procedures Manual (RPM) under the entitled section “Coverage of Personal Importations,” which states the FDA should consider not taking enforcement actions against certain cases of importation, specifically when the intended use of the drug is unapproved and for a serious condition as in Sally's case for which effective treatment may not be available domestically either through commercial or clinical means. Also, when the product is considered not to represent an unreasonable risk. Moreover, when the individual seeking to import the product affirms in writing that it is for the patient's own use under the recommendation and the supervision of the health care provider. Although the PRM provides that the importation should generally not
Show More

Related Documents: The Pros And Cons Of The FDA

Fda Pros And Cons

There are pros and cons that the FDA would have to face if the procedure to approve new drugs was expedited. As mention in the article, there might be consequences such as side effects and death. In contrast, there might be the possibility that if the FDA quicker approved this new drug, this new discovery could cure diseases like cancer and HIV/AIDS. However, if these newly developed drugs are not thoroughly tested, the results could cause more harm than good. The FDA should not speed up the approval…

Words 268 - Pages 2

Fda Pros And Cons

A pharmaceutical company must have approval through the US Drug and Food Administration (FDA) before they can market and sell their drug. These tests on not done by an unbiased party, the tests are overseen by the company that created the drug, “The FDA does not conduct independent tests or compile independent data…” notes Dr. Winifred Hayes, “…instead, the agency relies on clinical trials provided by the drug maker to determine drug safety. This is, arguably, a flawed process. It is clear to see…

Words 350 - Pages 2

Pros And Cons Of Monsanto In The FDA

progressively purchased out each progression of conceivably halting their item in the US. The FDA has evidently not looked too far into the instance of the unsafe impacts of the development hormone. I think Monsanto has paid off numerous in the FDA to look the other way and pass the medications through the regulation procedure. So the Monsanto has progressively done what Brawndo has in purchasing out the FDA to go through items for the additions of benefits. Concerning Fox now’s instance of shriek blowing…

Words 390 - Pages 2

School Lunches Research Paper

My topic is the pros and cons of schools serving fast food for lunch. Personally I think they should serve fast food because it's better quality food, it tastes better and more kids will eat at school instead of bringing their lunch. Some pros and cons about serving fast food for school lunches. Pros are its better quality food. Kids will like it a lot better than regular school food, kids won’t go without lunch because they like the food. Some cons are the schools might have to pay more, some kids…

Words 216 - Pages 1

Compare And Contrast Eat Your Bugs Essay

page 3 of “insect farmers” it says A wave of illness can knock out a farms supply for weeks. This information differs because eat your bugs is saying a pro of eating bugs and insect farmers are listing a con of bugs.To sum things up...the two articles differ because insect farmers lists the cons of eating bugs while eat your bugs are listing the pros of eating bugs. In concluesion the two articles “Eat your bugs” and “insect farmers” are very much the same, because they both mention that bugs…

Words 508 - Pages 3

Gmo Research Paper

other organisms similar to its kind. Although some believed that GMO foods may have several benefits to one’s health, there are others who believed consuming these products will adversely affect their general well-being. The pros and cons of consuming these products include: Pros Insect Resistance Manufacturers of GMO foods believed that they are more resistant to insect pests because of the toxic bacterium which is added to the plants as an insect repellent, and it is very safe for us to consume.…

Words 836 - Pages 4

Currents Events Essay examples

The “Morning After Pill” Debate I had actually written a paper on a different subject but when this came across the news the other night, I couldn’t resist. The FDA has decided to lower the age at which people can buy the Plan B One-Step morning-after pill without a prescription and right over the counter, from age 17 to age 15. Birth control for anyone under the age of 18 has always been a controversy it seems. Now, with this issue, it has pushed birth control once again into the limelight…

Words 427 - Pages 2

Artificial Sweeteners

written by the Mayo Clinic. In addition, my group supplemented the article’s information with a research study from The International Journal of Clinical Practice. Proving its credibility as a source of information, the Mayo Clinic weighed the pros and cons of artificial sweeteners. One benefit of consuming artificial sweeteners is that there is no caloric intake involved, even though artificial sweeteners are much sweeter than regular sugar. However, the article mentions that there was a research…

Words 422 - Pages 2

Speech: Cannabis Essay

you about the many pros and cons of the cannabis herb. there are many random unknown fact about this plant and the effects it has on the human body. The marijuana plant contains several chemicals that may prove useful for useful treating different illnesses or symptoms, leading many to argue that is should be legal for medical purposes. Many states have legalized the plant for certain medical uses.The study of the active chemicals in marijuana called cannabinoids has led to the development of two FDA approved medications…

Words 734 - Pages 3

Essay on Food: Food and Drug Administration and Dietary Supplement Health

herbal medications to be advertised and sold without FDA regulation as long as the product is not specifically represented as a treatment for a disease. What are some benefits of this decision? What are some drawbacks of this decision? According to the chapter, as previously mentioned the 1994 Dietary Supplement Health and Education Act paved the way for herbal medications to be advertised and sold without FDA regulation. There pros and cons were mentioned as the sub- heading went into more depth…

Words 323 - Pages 2