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Just Answers - The American People want blah, blah, blah
Sean Hannity insists he knows. Al Franken often speaks for us. President Bush and Dick Cheney always seem to be crying our collective thought. Senator Kerry claims he is our spokesperson. They and their ilk unapologeticall
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
y will tell anyone anywhere anytime what “the American people” want, as if they really know, as if it is fact.
The last time I checked, I was an American and still believe to be so as I write this. And I have to tell you,
The last time I checked, I was an American and still believe to be so as I write this. And I have to tell you,
; 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
not one of these knuckleheads knows what I want. And when I hear a politician or a media propagandist start a self serving opinion with the words “The American people …”, I want to jam hot pokers into my ear canals. I wis
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
they would just shut up about the American people. They don’t know what the American people want because it is a myth to believe that there is some kind of unanimous American position on anything.
Let’s take a simple exa
Let’s take a simple exa
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
mple, one in which all victorious Presidential campaigns indulge in one way or another. To do so though, I have to turn one of my favorite targets, Press Secretary Scott McClellan. He was being nagged during his press brie
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
fing the day after the 2004 Presidential Election to identify the issue that brought a record number of people to the polls. Scott, as only Scott can do, answered the inquiry with the following (pulled from the transcript
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
n its entirety; i.e., full context):
“No, I'm not (going to comment)-- there's going to be plenty of time to do a post-election analysis of all these issues. There was a very clear choice in this election, and the America
“No, I'm not (going to comment)-- there's going to be plenty of time to do a post-election analysis of all these issues. There was a very clear choice in this election, and the America
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
n people spoke at the ballot box with an overwhelming -- with overwhelming support for the President and his agenda. That is clear from the results.”
The overwhelming voice Scotto and the legions of talking-point pundits
The overwhelming voice Scotto and the legions of talking-point pundits
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
were referring to that day was the 51% of the popular vote Bush received over the 48% John Kerry obtained. Or possibly they measured the overwhelming majority by the final electoral count.
Well here is a fact. If John Ker
Well here is a fact. If John Ker
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
y could have grabbed just 51,000 of the votes Bush received in Ohio, he would be president today—granted he would have won without the popular vote buy hey, President Bush knows all about that. Given that President Bush’s
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
campaign played the wartime president card, something that supposedly strikes the fear of change into the hearts of voters, it is hard to imagine proclaiming overwhelming support for “the President and his agenda” without
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
a hint of a smile on one’s face.
But forget all that. Let’s say a 3% margin is some sort of mandate as Scott would have us believe. Or let’s say the infamous map of red counties versus blue counties is some sort of clear
But forget all that. Let’s say a 3% margin is some sort of mandate as Scott would have us believe. Or let’s say the infamous map of red counties versus blue counties is some sort of clear
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
tatement. Is it still fair to proclaim the “American people spoke”?
Well that depends on how you define American people I guess. I define Americans as people who are legal citizens of United States. I’m not sure there is
Well that depends on how you define American people I guess. I define Americans as people who are legal citizens of United States. I’m not sure there is
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
a better answer. The truth is that of the 220,400,000 legal U.S. citizens over the age of 17 (i.e., potential voters, as documented by the 07/2004 census), a little more than 28% voted for Bush, a little less than 27% vote
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
d for Kerry, under 1% voted for other candidates, and over 44% chose not to vote at all. A whopping 44% did not participate! And this was a record turnout!
Is Chris Matthews speaking of them when he makes a claim for the
Is Chris Matthews speaking of them when he makes a claim for the
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
merican people? Is Ann Coulter proclaiming their needs with her know-it-all assertions?
For once in his life, if McClellan could have spoken frankly and truthfully, he would have had to say something like:
“There was a v
For once in his life, if McClellan could have spoken frankly and truthfully, he would have had to say something like:
“There was a v
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
ery clear choice in this election, and 44% of the American people chose not to make a choice. There is no agenda that has overwhelmingly captured the attention of those Americans. That is clear from the results.”
If there
If there
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
is any generality that can be drawn, it is that a significant proportion of Americans don’t speak with a flip of a lever or the punch of a card or the check of a box. I suspect they don’t watch FOX or CNN or C-SPAN, nor d
.
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
they participate in their polls. I suspect they don’t read the NY or Washington Times either. One thing I know with certainty: no one speaks for them, no one speaks for me, and I suggest no one speaks for you.
So the nex
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 time someone tries to tell you what the American people want, simply replace the phrase “the American people” with “I” or “me” and you will understand the buffoon’s real agenda. Then shove hot pokers into your ear canals
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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