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Answers - Alito Chided by Senator Kennedy for Application Statement
Senator Edward Kennedy (D., Mass.) questioned Supreme Court nominee Samuel Alito regarding statements he made in his 1985 application to be deputy assistant 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
ttorney general. (His entire application is available for review at "TheSmokingGun-dot-com," but the pertinent part is on page two.) The senator specifically
; 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
sked him about his opposition to abortion and his belief that the U.S. Constitution "does not protect a right to an abortion."
According to the Associated Pr
According to the Associated Pr
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ess, Kennedy reported Alito replied that he wrote those statements as "a member of the Justice Department that was interested in getting a job." Kennedy said
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
e then asked Alito, "Why shouldn't we consider that the answers you're giving today are an application for another job?" In other words, Mr. Nominee, give it
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
o us straight. Don't tailor your words to fit your audience; don't say what you think they want to hear.
Reading over Alito's application, I agree with his s
Reading over Alito's application, I agree with his s
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
tatements. Like him, I am in favor of judicial restraint. I believe in traditional values and am convinced that the Constitution does not protect a woman's ri
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
ht to have an abortion. Yet I also agree with Kennedy. Alito would command a great deal more respect if he merely said, "I stand by what I wrote in 1985. That
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
document represents my ongoing commitment to interpreting the Constitution according to original intent."
According to Proverbs 18:4, "The words of a man's m
According to Proverbs 18:4, "The words of a man's m
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
outh are deep waters, but the fountain of wisdom is a bubbling brook." In other words, you usually can't tell, based on what a person says, what is really in
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
is or her heart. But if the person is truly wise, they will be as transparent as a bubbling brook. Such transparency comes from integrity--a wholeness of bein
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
in which there is no conflict, no double-mindedness, no fence-straddling to coddle public opinion.
That's the kind of integrity Jesus Christ had: the onenes
That's the kind of integrity Jesus Christ had: the onenes
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
s of spirit and purpose that he compared to a lamp burning on a lampstand, not under a basket (Luke 11:33). In the next verses, He challenges us to have the s
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
me kind of integrity: "See to it, then, that the light within you is not darkness. Therefore, if your whole body is full of light, and no part of it dark, it
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
ill be completely lighted, as when the light of a lamp shines on you."
This kind of integrity is what we need in a Supreme Court justice, someone unafraid to
This kind of integrity is what we need in a Supreme Court justice, someone unafraid to
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
hold onto deep convictions, unswayed by public opinion. We need someone who will fully engage in the vigorous debates justices often have behind closed doors
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
who will be open to the force of legal precedent, to the weight of a logical argument, or to the persuasive power of evidence, regardless of who has the mone
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
, the influence, or the prestige. Yet it seems the confirmation process itself has a built-in bias in favor of someone who is colorless and bland, who has no
.
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
deep convictions, who lacks "bubbling brook" integrity.
We owe it to Judge Alito to consider the testimony of his friends and colleagues--those who know him
We owe it to Judge Alito to consider the testimony of his friends and colleagues--those who know him
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
est. We need to hear what they have to say on his behalf, not just a senator pursuing his own agenda. Want to "go deeper"? Check out "judgealito.com" for more
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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