TCE

Kratom Products Can Kill You, FDA Says

Kratom is a type of drug that either can be eaten in pills form, smoked, and injected. The name itself is a tree plant base, relative to the coffee family, and some says it has some therapeutically property to fight against pain and depression. The drug is an alternative of opium, well it almost behaves like opium, a narcotic and very addictive. Now in the news, the FDA is warning people about this untested drug, who is imported from other country and purchased via online. The drug has a high potential of side effects than positive, that the drug can even lead you to death. FDA is approaching to restrict/ban the importation of such drug and set it as an illegal drug in the U.S. In August 2017, the drug administration has petition in listed the drug as schedule 1, because the behavior of kratom acted the same way as other narcotic drugs. However, the communities of kratom has outcries the petition and with their collaboration efforts, the enlisting was withdraw from the lists. The drug is still available in the U.S. but with time soon the drug either be banned or legalized.

What the FDA are trying to do:
The FDA incentives the kratom companies to send their product evaluation before the drug is administer it sales over the sea. Otherwise, the company would loose it sales and productivity, because the FDA has the authority to detain and halt it shipments for safety and concern. without the product information requested by the FDA, the kratom product could mean it has high hazardous effect than good ones.

Proposal #2

On the first proposal of my research, I wasn’t sure on how narrow the topic should be. At first, I thought about researching the FDA drug regulation, how they regulate drugs, the system, their work itself, and the authority they possess. Additionally, to that, I wanted to incorporate a comparison between the FDA and the European German E Commission, who is also a government program that regulates drugs like the FDA. The problem with this approach is that I won’t be able to convey the main idea from my research, I should just focus on one aspect and the topic is “how do FDA regulates our drugs”.

The FDA (Food Drug Administration) is a fascinating organization that regulates most of our commodities purchases, such as food, drugs, equipment that has a connection to public safety and health concern. I wanted to explore the drug administration part, because of medicine. We as a human beings depend on medicine, we utilized them when we need them to treat illnesses. I wanted to know how FDA approve drugs, what are the steps and requirements for the procedure, and what does it count as a safety drug?

Steps and approach of my research:  

Ø  First is the introduction of FDA, the system itself but only at the drug department, and what rights do they hold (a little bit about policies).

Ø  Drug regulation:

·         The approval and steps.

·         What kind of rubrics do pharmacists have to follow in order to commodify their drugs.

·         How FDA make their decision when the case is on 50/50, I’m referring to 50 positive and 50 negative effect.

Ø  Do FDA test the drugs or is just based on the company research.

Ø  What are the penalization.

Ø  Last, maybe the future of FDA and what kind of approach and innovation they are leading, what steps they are taking, and what changes they are making?
 

Payers struggle to keep up with high rate of FDA drug approvals

Payers struggle to keep up with high rate of FDA drug approvals

The FDA approve these kind drugs faster than the common ones, the orphan drugs. Rather than being approved by clinical trial, the drug is monitored under the surrogate endpoint clinical, meaning the drugs will only require a minimum way to show it efficacy. Orphan drugs are the types of drugs that won't guaranteed for 100% cure, since the drugs are still in the beta stage, it only serves for the purpose of treating rare-disease that non-cure has been found. The FDA approve the surrogate endpoint clinical trial for these type of drugs (orphans drugs), it says that the clinical testing is more of a observing and researching for clues and evidences to understand more of the unsolved diseases. In a sense its more like a animal testing with no control, but in here its using the lives of real human to test it.
Something the FDA mentions to public about the drugs:
People should be aware and be more informative of these types of drugs.
People with rare disease should do more research about their disease and also research about the content ingredients found in these pills.    

Well, from my perspective view I think FDA should put a label where it allow the users to scan and access to the information about the drugs, informing them about orphan drugs, the pros and cons, and also letting the public be more aware of these types of medicine out there.