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.
