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Main Subject - Addressing Moral Decline of American Politics - Nu Leadership Series
“In the past a leader was a boss. Today's leaders must be partners with their people... they no longer can lead solely based on
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
positional power.”
Ken Blanchard
Who is accountable in Washington? As the Foley scandal spiraled out of control, gover
Who is accountable in Washington? As the Foley scandal spiraled out of control, gover
; 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
nment leaders took cover. Former Representative Mark Foley escaped congressional punishment by resigning in the middle of the scanda
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
l. House Speaker Dennis Hastert proclaims that he did not do anything wrong; however, Hastert publicly stated he accepts full respon
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
sibility. Many in Congress worried about the political fallout. Internal polling had shown that House Republicans could suffer massi
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ve loses if Hastert doesn’t resign. The results were much worse.
On election day, voters led a massive revolt against the incumbent
On election day, voters led a massive revolt against the incumbent
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
s. This created one of the largest congressional shift since 1994. Exit polls showed that voters were more concerned about ethics 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
an any other subject. Four Republicans resigned from the House this year due to ethical issues. Currently, American politicians su
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ffer credibility problems. An USA Today/Gallup Poll of 1,009 adults found that only 15 percent of the people gave U.S. senators hig
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
h or very high marks for honesty and ethical standards. The U.S. representatives didn’t do any better at 14 percent.
As each party
As each party
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
tries to either take advantage of a “hot button” issue or perform damage control, followers grow increasingly cynical about governme
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
nt leadership. Both party expects each congressperson to follow the party line. Sometimes this blind obedience leads to going agains
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
t one’s principles. Obviously, this is done with transactional relationships with peers. On the other hand, ethics guru Cuilla maint
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
ains that coercion is not true leadership. She argues that ethics is at the heart of good leadership.
If one evaluates these statem
If one evaluates these statem
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
ents, the question becomes, how can any good leader blindly follow any group or party? What is the price of surrendering one’s core
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
values? A true leader stands up for his principles even though it may be forced to go against his social network. Therefore, polit
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
icians need to foster more value-based leadership.
References:
Ciulla, J.B. (1998). Ethics: The Heart of Leadership. Westpo
References:
Ciulla, J.B. (1998). Ethics: The Heart of Leadership. Westpo
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
rt, CT: Praeger.
FoxNews.com (2006). Hastert sys he did nothing wrong in foley page scandal. Received on October 13, 2006, from htt
FoxNews.com (2006). Hastert sys he did nothing wrong in foley page scandal. Received on October 13, 2006, from htt
.
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
p://www.foxnews.com/story/0,2933,217943,00.html.
Koch, W. (December 12, 2006). Poll: Washington scandals eating away public trust.
Koch, W. (December 12, 2006). Poll: Washington scandals eating away public trust.
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
USA Today.
Margasak, L. (October 8, 2006). One thing’s for sure in Foley investigation. Associated Press.
© 2006 by Daryl D. Green
Margasak, L. (October 8, 2006). One thing’s for sure in Foley investigation. Associated Press.
© 2006 by Daryl D. Green
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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