Final blog

Medicine has always been part of our life, we take them and used them upon encountering with illnesses or diseases. The cure, it is our responsibility to explore it and search for it, in a way we can find measures to counter the circumstances. Drugs are not made to be perfect, not with the therapeutically effect to fight off all the diseases, but there are good drugs out there that have been researched over many times. It can cure but sometimes not, we take them for the main purpose of prolonging our life. Drugs is a wonderful thing; it is this enthusiasm that keeps me interested in medicine, which is in this blog, I’m researching about the FDA (Food Drug Administration). More in depth, I want to study the drug system of the FDA and how safe is the system. What I am hoping to gain from this research is a closer understanding of the FDA complex system, being able to see why they approach certain situation in this way and also see why is difficult to solve the task (by task I mean the problem inside the system). Although, throughout the research, I understand that all the finding will not guaranteed to satisfy from what I’m truly looking for, but with what is provided to me, to get me closer on understanding the system is enough to contemplate my curiosity.        

The FDA, also known as the Food Drug Administration, is an executive branch of the United States, responsible on regulating and protecting the public safety, such as food, drugs, medical devices, and items related to health… The FDA is comprised of many industries; they each regulate on specific tasks. In our case, the drug industry focuses on regulating drugs, alert the pharmaceutical companies, executing permission on approving new drugs, and etc... For my understanding of the drug industry, I want to focus on the system that regulates drugs and what kind of opinion does the public perceive. FDA do not test the drug, it is the company responsibility to test and send the information to the FDA. The process for a new drug approval follows a 6-7 steps before it released into the market. In the preclinical stage, the drug compound is studied, screened (a method of measuring the toxicology of the chemical), and it is tested on animal clinical trial. After the animal trial, the drug can be studies in human clinical trials. There are total of 3 stages for human clinical trials, on phase I, the drug is sampled on 100 patients without the disease/illnesses, at this stage is to evaluate whether the drug can be dangerous to healthy people. Phase II, the drug is tested on 100 patients with the disease the drug is corresponded to treat. Measure of the cells, information about the condition and side effect are recorded down. In Phase III, the study is conducted with 1000 patients with large variety of people (any kind of people can be studied), the process follows a similar study trial like in phase I and II, but in this case of the study, the data collected is larger, and have more way to measure the therapeutically effect of the drug. If overall the study has more positive result out weight the negatives one, the information could be ready to submitted for market approval. All the research stage data and information are compiled into monographs, the information, around 100,000 pages are then send to the FDA’s drug department for asset and evaluation. The time for the drug approval and decision will depend on the types of drug the company is interested on marketing. Like fast track, the drug is approved in less than 6 months, this only work if the medical condition is serious and haven’t found a cure to address the problem. Other drugs, responsible of targeting a large public (ex: heart problem, diabetes, and cancer…), the time for approval will depend on many factors, how many drugs is made up and how effective do they measure the clinical study. To get an acceptance and certification of their drug by the FDA, it means the pharma company is enable to manufacture the product, however, FDA does still keep a check on the drugs even if is approved. They require a report and data of the drugs every year to evaluate the drug process and efficacy. In my opinion, the FDA drug approval system has pros and cons effect, the pros it allows more drug to be researched and discovered. The cons are the approval rate is too fast, we do not know whether the pharmaceutical company submitted a truthful information about their research, because on some of my readings, they mentioned about FDA hiding drug awareness to the public. What the article found is that 700 reports provided from the pharma companies contain false information about their drugs. This could mean a big taboo to the FDA and an increase the concern by the public view. Of course for this error to happen in the FDA, it must mean there are some collusion going on inside the system. Since money plays a big role, the FDA gets most of their funding thru pharmaceutical companies and small from our taxes. It is dangerous to allow such person to continue and operate inside the system.

From my finding of this research, I think I learned a lot about the system. I didn’t know about FDA drug approval process, but one thing that shocked me is the information available on the internet. Some information provided can be very truth or false, depending on how the person judge on their words. However, even if they sprout negativity around, it is good to learn and understand from it, maybe the FDA can one or two learn from their mistakes. A mistake always makes a person perfect if he/she pursuit for the changes.

What got me into researching this topic? Well, I took a course about medicinal plants and I learned a lot about traditional medicine. I thought maybe is a good thing if the U.S. hospital also practice herbal healing and traditional therapeutically practice, I think this could reduce the diseases problem in the U.S. Like acupuncture, it is a good alternative approach to remove pain rather than using drugs. As drugs could sometimes contain side effect or addict the person in the case like the opium addiction that is still happening in this country. FDA does not regulate herbal supplemental drugs under on one condition, they are not allowed to make claims on their drugs. If they follow the FDA rules, they wouldn’t have a problem in the market. Otherwise law cases and other political conflict will follow. Now, the last finding of my research, it based on a survey regard on public opinion about the FDA’s drug. From the poll survey, it shows that majority of the people feel safe with the FDA, and from 2016-2017, the public perception of seeing the FDA safe is increased a little bit. This mean people think the FDA is doing a great job. In this case it is true, the FDA has been trying hard on fixing many things that has sprouted around them. They have been carefully removing certain dangerous drug in the market, despite it took them long to commit the action. I think the FDA’s drug system is improving but at a slow rate. To me they seem to be putting more effort in securing the drug safety of the public, as they are investing more time in redesigning the system. I can understand why the system is slow, because to start with the organization is not very big enough to tackle all the adversities at once. New drugs discovery is not easy to regulate either, as the pharma companies have to invest a vast of resources into producing a less dangerous one to the public. The time average to make and get a new drug approved by the FDA is about 12 years. The cost is around 2.6billion in order to get it into the market. This is very costly and time consuming as the pharmaceutical companies will try to find alternative ways get a faster result and approval rate. In the health care is also make sense on why sometime the drug are very expensive, because the drug has been through many research and evaluation by the FDA and drug companies. Once the drug established in the market, the pharma companies will try to earn back the cost they have spent on funding the project. Therefore, managing the system is still very complex under the FDA; FDA will try to find a better way to promote a better safety and security for the public.

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.

FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments

"Click"

Time is precious as FDA seriously needs it. The FDA systems or more specifically, the FDA drug administration is still lacking a proper system to navigate them as a whole. "Time" certainly is one of their main key for them to solve the organization's structure. However, FDA is not the only one who needs time, other drugs, therapy, and medical devices industries are still needing time for their items to be in used and approved by the FDA. All medical equipment's, drugs, food, and products (related to consumption) must have gone through the FDA before it to  appears in the our shelf. Selling such items without the approval of the FDA can lead to public in state of unsafety and endanger. In the case of this article, they talked about the closing of a unapproved stem cell treatment prescription drug . The FDA is shutting it because the information of the treatment didn't went to them before it was allowed to be utilized. The hospital was against it ( they were mad at FDA for restricting too much) and says that it can cure or proceed quicker of the drugs result, kind of like a clinical trials. But, under the  FDA evaluation, the drug is still considered a shut down drug, even if is for the purpose of testing, a drug will be a drug that's what they are trying to say (the FDA), any drugs will certainly contains an ingredients that can be harmful to us. An unapproved drug shouldn't be used unless is agree by the consent of the patient.

FDA Unveils Ramped-up Regulatory Initiatives for Drug Compounders

FDA Unveils Ramped-up Regulatory Initiatives for Drug Compounders

Statements FDA made, some initiatives that FDA stated in effort to put more work on regulating compounded drugs (contain more than one chemical ingredients and are prescribed at the exact dosage and amount to patients).

The implements FDA are trying to press:
1) requires information of the drugs, list of chemicals, experiments, trials, and data to ascertain it safety.
2) Request information of the facility to conduct investigation.
3) Allow intergovernmental interrogate and coordinates on the compounded drugs to show FDA are engaging in issue matter.

FDA’s Authority to Regulate Off-Label Promotion

FDA’s Authority to Regulate Off-Label Promotion

I think this article is interesting to understand the power of FDA and how they proceed on certain actions. In the case of this article, is about the off labeled drugs and it promotion sales in public. The off label drugs are drugs with little proof and low scientific evidences supported, the risk of intake such drugs are high and dangerous, because they often are mislabeled or aren't meant to cure. On the hand of the FDA, they do have the authority to press charge and regulate the off-label drugs, however, other principals laws from the federal can interfere with the FDA regulation. The way off-labeled can get away from it is by carefully label their products and provide little evidence. FDA under the federal laws, they do have the rights to ban and remove certain drugs but on the off-label drugs, the way they handle the situation is by squeeze play (processing something with little effort).

Introduction

The world of drugs

The clock ticks and then it beeps, it's time to take our medication. We take pills everyday, every months, and every years, but why isn't the drug taking effect on our illnesses? Is our drugs wrong? or perhaps we are wrong. Medicine has been circulating through our lives, we consume it and depend on it for the sake of our own health. But why do we still consume it even if it does not improve our health condition? A majority of people intake medicine because they want to live longer. If that is our goal from consuming drugs, then we should take another level into considering the whole scenario, we should question ourselves, what it is in our drugs? are government properly regulating it? and is it safe to consume it? The truth to answer these questions can varies, there are many factors and rumors out there that can correlate on answering the questions. One may think positive about our drugs, another stated neutral minded, and other object the drugs with a negative influence. From the three option listed there, one of them can describe each individual person's perspective, whether is positive, neutral, or negative, they all represent our own opinion. However, we human tend to judge. We blame things to escape from the issues but blaming is not the only way it can solve our current drugs problem. Instead of prejudicing on the subject matter, we should carefully consider around us and examine the world we live in. Yes, a world in high technology and advance in science, we live in a busy world that surrounded us (constantly working). We rarely have the time to  look at our medicine's ingredients and investigate the chemical property. Therefore, in this article, we will be exploring the FDA, more specifically how our drugs arrives into our hands.

Prompts that would be focused on:

• A comparison between Europe drug administration versus U.S drug administration department.
• How are FDA regulated and how they get funded?
• How are our drugs approved?
• Chemical usage and compare it to other countries.

Proposal Objective: Explore FDA and its step procedure on regulating our drugs. How do we trust the FDA, and is our drugs properly tested before they are labeled on our market?