Are you in the process of making a
drug to treat a disease? Well, you are in for a ride. The process of getting a
drug approved by the FDA is a long, tiring, financially exhausting path. One of
the guests that I had the privilege to listen to the talks of was Dr. Michael
Decker. During his talk, he explained that many researchers in the process of
getting approval from the FDA will either run out of money because of the billions
of dollars it takes to research and produce the drugs or that they will get
rejected by the FDA because the drug is not effective to the majority of the
population. These two major obstacles will make an already long process even longer.
There are 3 major phases that a drug must pass in order to even be considered for
approval by the FDA. For all drugs, it must be first tested on lab mice or
certain other animals before it can pass the initial phase of research and experimentation.
Once this initial phase is surpassed then only it will be sent for testing on
humans. This process is done in three phases which consist of first testing to
see the danger levels of the drug on humans. This might include side effects
and long-term effects. Next it will be tested to see how effective it is for
the disease it is said to treat. Once these two steps are passed then it is
tested to see if it is effective for the general population, because sometimes
a drug is only effective for a small sample of people but that is enough for
the approval by the FDA. The aim is usually to see effectiveness in the
thousands of people. While these phases are happening it’s probably already
have been several years, and if the drug happens to pass all these steps then
only it is sent to the FDA for an approval or denial decision based on the experimentation
and research.
Another possibility that can
happen is that the FDA has the power to approve or deny the drug initially but
it can also take a drug out of the market if it deems unfit. An example of this
is seen in the drug that is used for breast cancer called Avastin. Avastin was
first used for colon cancer in 2004 but then later was approved for the use
against breast cancer in 2008. The FDA is arguing that there are severe side
effects associated with this drug for women which include high blood pressure, heart
attack as well as internal bleeding. The reason the drug was approved in the
first place was because it limited the growth of new blood vessels which had
potential of suppressing the growth of the tumors. Despite this evidence, there
was a unanimous vote for the drug to be revoked approval by the FDA’s Oncologic
Drugs Advisory Committee. Some of the advocates or members had argued against this
decision because they still wanted the patients that were already fighting the
disease to finish treatment. Genentech, the producers of this drug say that they
will continue to research the drug and make it safer for the population. Initially
this drug did not go through the long strenuous process for getting approved for
breast cancer. Maybe this is the reason it is causing these problems.
Is the process of the getting a
drug approved by the FDA a good methodology or should it be expedited? Some may
argue that patients are in dire need of treatment options and this strenuous process
is what is keeping the patients from receiving treatment. Also, others would
argue that the process is put in place to make sure it is effective and safe
for all patients. Debates can be done from both sides but who is correct?
People may form their own opinions but it does all come down to the FDA and
their approval. Does it need some changes? Maybe. Also keep in mind though that
it is there for a reason, if any drug is not regulated then there is always
potential for it to cause harm or may not be even effective at all.
Harmon, Katherine. “Use of Avastin
for Breast Cancer Nixed by FDA.” Scientific American Blog Network, 18
Nov. 2011,
blogs.scientificamerican.com/observations/use-of-avastin-for-breast-cancer-nixed-by-fda/.
Mohs, Richard C., and Nigel H. Greig. “Drug Discovery and
Development: Role of Basic Biological Research.” Alzheimer’s
& Dementia: Translational Research & Clinical Interventions, vol. 3,
no. 4, 2017, pp. 651-657., doi:10.1016/j.trci.2017.10.005.
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