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“ Choosing one's leaders is an affirmation that the person making the choice has inherent worth.” Linda Cha

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

vez

As I glanced at the news, I was reminded of the ugliness of humanity. Do we really need another ethical scandal

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

Examples of combination products may in

in America? Bernie Ebbers, WorldComm founder, started a 25-year sentence for an $11 billion account fraud. Likewise, HP

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

ad its own embarrassing moment with scandals. Recently, HP decided to keep Board Chairman Dunn after the chairman was di

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

scovered wiretapping her board. What are these executives thinking when they conducted these transgressions against thei

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

Combination pro

corporations?

Does character count in capitalism? Guinness, a religious authority, explains that contemporary society

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

iews character as something that distinguishes an individual; however, biblically, character is viewed as essentially mo

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

ral. In many cases, character doesn’t count in secularism.

Most corporations preach high ethical behavior but are side

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

racked morally by the bottom-line. Joyner, author of Leadership Management, argues that outstanding leaders fail unless

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

heir lives are underpinned with honor, morality, and character. Under the current model, anything goes. Don’t get caught

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

Any path will do. However, Jesus disagreed in Luke 13: 24 “Do all you can to go in by the narrow door! A lot of people

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

Following aspects would a

will try to get in, but will not be able to.”

Don’t expect companies to clean themselves up. However, a wave of moral c

dd to the challenges in developing combination products:

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

nduct is coming. Maynard and Mehrten, renowned futurists, maintain outside forces will demand high ethics and a moving a

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

ay of a focus solely on material gain.

Therefore, leader get ready. We are entering this moral revolution.

Referenc

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

es:

Guinness, O. (2000). When No One Sees. Colorado Springs, CO: The Trinity Forum.

Joyner, R. (1994). Leadership

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

anagement. Charlotte, NC: MorningStar Publication.

Maynard, H. & Mehrten, S. (1996). The Fourth Wave: Business in the 2

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

Professional from academic institutions, pharmaceutical industries, health care indust

st Century. San Francisco: Berrett-Koehlers.

USA Today.com (September 13, 2006). New HP chief makes the best of a bad s

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

ituation. Received on September 26, 2006, from http://www.usatoday.com/money/industries/technology/2006-09-12-hp-hurd-ad

.

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

antage_x.htm.

USA Today.com (September 26, 2006). Ebbers winds up at federal prison in Louisiana. Received on September

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

Companies that provide selfless information through particip

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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