Advice Pool - Reference and Education

From the very childhood most parents teach their children to be obedient and stress that obedience is a virtue, and disobedience is a flaw. That is the opinion accepted in the society. There exist a

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

lot of religions that teach us to be obedient. But is disobedience really a demonstration of someone’s rottenness or is that something different? Erich Fromm has stressed out several aspects that sho

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

us the contrary. He believed that disobedience is always an act, a manifestation of someone’s will or idea. He also stated that obedient man is actually a slave, not a fully developed human being. T

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ird his statement that can be read between the lines: that the efforts of disobedience move the progress.

Disobedience is an act. To be obedient is easy: you just go with the stream. To be disobedie

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

nt means to take a risk, and disobedient individual nearly always realizes the consequences of his action. Therefore, disobedience is a demonstration of a) character b) thoughts c) constructive appro

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ch. It is also one step forward compared to obedience, as it can possibly lead to some changes. “One has not only a legal but a moral responsibility to obey just laws. Conversely, one has a moral res

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

onsibility to disobey unjust laws” (Martin Luther King, Letter from Birmingham Jail). Disobedience can also be a manifest of someone’s moral values while obedience doesn’t give a chance to express th

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ese values.

Obedient man is actually a slave. An obedient person follows the rules, which were created before, regardless of the fact whether the game directives are fair or not. “Although the villa

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ers had forgotten the ritual and lost the original black box, they still remembered to use stones” (The Lottery by Shirley Jackson). This story is a vivid demonstration of how people become slaves of

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

an uncivilized tradition. The scientists have once held an experiment: they put five monkeys in a cage and put the bananas in it. Each time one monkey tried to take a banana, all five were stroken wi

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

h current rush. In some time, when a monkey wanted to take the fruit, others started hitting it. That’s how the tradition was created. And then scientists changed the monkeys in the cage one after on

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

e, and turned off the current. As s result no one was hit by the current, but the monkeys went on terrorizing the one that wanted to take the banana.

That is a pure example of obedience in its worst

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

meaning. And Fromm tells us that such cases are intolerable. A human should not be a slave of the tradition, like those monkeys, but a thinker and thus disobedient one. The efforts of disobedience mo

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

e the progress. Fromm stresses that without the disobedient people, without the prophets and revolutionaries there could be no way forward. He also expressed a thought that such changes in the societ

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

y, the existence of prophets and leaders would be unnecessary if all people were disobedient in the sense of realizing their actions, and not blindly obeying something.

According to Erich Fromm, dis

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

bedience is not a vice. It is the manifest of a true human being able to think and interact with the outer world. He expressed a fear that “Human history began with an act of disobedience and might e

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

d with an act of obedience”, which actually meant that the mankind is going the wrong way – the way of making everyone standard. Fromm sees this way as a deadlock. Society can only be truly human if

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

it consists of thinking people, who are more disobedient than obedient.

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Fromm sees the increasing influence of power of state, society etc. on an individual in our times. The pressur

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

of power makes people alike, not able to reason and criticize; and such people cannot be disobedient. So, for the sake of life this should be stopped … and tomorrow is with those who are DISobedient

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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