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Main Subject - Just Do It and Ask for Forgiveness Later
The greatest shifts in American culture tend to originate from the media, but even something as innocuous as a saying can drive a cultural change. One saying in particular seems to epitomize a cultural shift that seems to be going unnoticed.
“Just do it and ask for forgiveness later.”
Heard that one
“Just do it and ask for forgiveness later.”
Heard that one
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
lately? Used that one lately? We all have, and most of us have likely heard this used at work.
The first time I heard it, I was a little shocked. It sounded like something I would have used as a kid while trying to rationalize using Mom’s Visa Card without her knowledge. Taken aback, I looked back a
The first time I heard it, I was a little shocked. It sounded like something I would have used as a kid while trying to rationalize using Mom’s Visa Card without her knowledge. Taken aback, I looked back a
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
t my manager to see if he was serious; he was. The walls of resistance softened, and I began to nod slowly. The stamp of authority seemed sufficient to justify doing something that I would not have ordinarily done.
Maybe I was raised with unusual values. My parents were adamant that I say “please” an
Maybe I was raised with unusual values. My parents were adamant that I say “please” an
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
d “thank you”. I didn’t tell my parents where I was going or what I was doing; I had to ask. May I go to Suzi's house? Can I borrow your earrings? It wasn’t considered good manners to take things that weren’t yours without asking, and it wasn’t okay to do things without checking in with other people f
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
irst, especially authority figures.
The ironic thing is that those values segued nicely into the professional world. We don’t go into someone’s office and take a file from their desk when they aren’t around. We wait until they show up and then we ask them for the file. We don’t make big decisions wit
The ironic thing is that those values segued nicely into the professional world. We don’t go into someone’s office and take a file from their desk when they aren’t around. We wait until they show up and then we ask them for the file. We don’t make big decisions wit
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
out communicating with others first. We consult with our managers, discuss with our team members, loop in our clients.
But one day we started saying things like, “It’s okay, we’ll purchase it now and ask for forgiveness later when Finance realizes it went over budget”.
I took a moment to deconstruct
But one day we started saying things like, “It’s okay, we’ll purchase it now and ask for forgiveness later when Finance realizes it went over budget”.
I took a moment to deconstruct
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
what was happening here. First, let’s state the obvious. In these cases, the person knows that they are doing something wrong. They know they are going over budget. But, they don’t care. They have an opportunity to approach Finance and have a conversation with them about getting the necessary approva
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
l. They don’t do it because they know the request will be denied. So, they take the conniving, underhanded, manipulative route instead. When you catch yourself using the same strategy as your eight year old kid, you really ought to slap yourself on the hand and reconsider your approach.
Now, perhaps
Now, perhaps
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
I’m overreacting and reading into this a bit too much, but here’s a perspective on what this “approach” to life and business is really enabling:
• This seems to suggest that you can do whatever you want with total disregard toward others as long as you follow it up with an obviously insincere apology
• This seems to suggest that you can do whatever you want with total disregard toward others as long as you follow it up with an obviously insincere apology
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
later
• It appears to be socially okay to disrespect others. According to this, you can borrow your roommate’s things without asking and steal your coworkers food from the fridge at work. For the truly advanced, you can violate rules, go around the system, thumb your nose at the law and cheat on you
• It appears to be socially okay to disrespect others. According to this, you can borrow your roommate’s things without asking and steal your coworkers food from the fridge at work. For the truly advanced, you can violate rules, go around the system, thumb your nose at the law and cheat on you
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
spouse – as long as you can con them into accepting your apology if you get caught.
No wonder systems aren’t effective! It’s no surprise that people don’t trust others. Doing it and asking for forgiveness later is becoming a norm, which is now accepted and even worse, tolerated. When we go over budg
No wonder systems aren’t effective! It’s no surprise that people don’t trust others. Doing it and asking for forgiveness later is becoming a norm, which is now accepted and even worse, tolerated. When we go over budg
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
et, Finance reworks the numbers and fits it in somehow (usually by taking away from another department).
And what is it that we are actually tolerating? At the root of this, aren’t we are tolerating being blatantly disrespected? In some cases, the person knew they were doing something that you would
And what is it that we are actually tolerating? At the root of this, aren’t we are tolerating being blatantly disrespected? In some cases, the person knew they were doing something that you would
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
not have approved of (forging your signature, having an affair), and yet they did it anyway. In other cases, they didn’t know whether you would have approved of it or not (borrowing your snowboard, drinking the last of your milk). We don’t consider that we may be inconveniencing that person for our ow
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
n immediate benefit. “Who used up my milk? I needed it for a dessert I’m making tonight. I don’t have time to run out to the store now.”
Regardless, there seems to be an entitlement factor that is driving our actions and decisions. It’s okay to do whatever you need to do to take care of yourself. Oth
Regardless, there seems to be an entitlement factor that is driving our actions and decisions. It’s okay to do whatever you need to do to take care of yourself. Oth
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ers will figure out a way to sweep up after you. Others will work around you and figure out a way to deal with it. Others will make adjustments (at their own sacrifice) based on what you did. In other cases, you’ll be able to talk your way out of it, buy your way out of it, or will simply accept the l
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
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
ss as a game that you didn’t quite pull off.
Those “other” people are real people. They are part of our universe, and what we do affects them. I guarantee you will find yourself on the receiving end of a counterfeit apology and pleading eyes, and I hope you recognize it for what it truly is. Instead
Those “other” people are real people. They are part of our universe, and what we do affects them. I guarantee you will find yourself on the receiving end of a counterfeit apology and pleading eyes, and I hope you recognize it for what it truly is. Instead
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
of accepting it, confront the person. Ask why they thought it was okay; if they don’t have a legitimate answer, tell them that you found their actions to be disrespectful and unacceptable. Attach and enforce real consequences. Let them know that you aren’t okay with the approach they took. If their be
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
havior left you questioning their ethics, judgment or integrity, tell them that. Stand up for yourself. Respect yourself enough to demonstrate to others that you expect respect from them.
The entitlement factor is so great that we have cast aside manners where we treat others with courtesy and respec
The entitlement factor is so great that we have cast aside manners where we treat others with courtesy and respec
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
t in favor of taking care of our own needs expeditiously. I fear that this may be the beginning of a cultural change where treating others with disrespect is socially acceptable, which can have truly disturbing consequences and impacts on our society.
I ask you to demonstrate integrity and build trus
I ask you to demonstrate integrity and build trus
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
t in others by rejecting this problem solving solution. We are not crafty children or wily teenagers, we are adults who have the knowledge, skills and savvy to render this tactic unnecessary in both our professional and personal lives. Set a new standard on respect for yourself and those you work with
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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