Main Subject - Business

Times are good. The economy is booming. Consumerism seems to be insatiable. In the midst

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

of it all there is a frightening trend appearing. Business ethics seem to be slipping awa

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

Examples of combination products may in

. Individual salespeople need to take heed and take personal responsibility in order not

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

o slide down the slippery slope that can limit or, worse still, destroy their careers.

T

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

ere used to be a concept called 'truth in advertising'. In most jurisdic

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

Combination pro

ions it is the law. Today, in general, it is a law that is rarely enforced and almost uni

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

ersally ignored by even the largest of corporations. Claims being made today are often ou

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

landish. Many are blatantly false and individual salespeople are encouraged to bring thes

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

exaggerations into the marketplace as companies seek short term profit.

The master sale

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

person realizes that longevity in the selling profession, on a personal basis, is based o

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

relationship building, strong referral business and ongoing customer loyalty. None of th

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

Following aspects would a

ese can be created or sustained by making exaggerated product or service claims, then und

dd to the challenges in developing combination products:

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

r delivering on those claims.

Companies that lie to sell their products or services may

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

urvive for a time but when the boom cycle ends, as it always inevitably does, these compa

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

ies will be among the first to fall. Salespeople who compromise their personal integrity

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

or short term gain will go down with these companies. Economic history is replete with th

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

Professional from academic institutions, pharmaceutical industries, health care indust

bones of companies that have over promised and under delivered.

While it is true that t

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

e marketplace is a place where the buyer needs to be aware, the words of P.T. Barnum are

.

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

lso true. "There is a sucker born every minute". Ethical companies and ethical salespeopl

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

Companies that provide selfless information through particip

do not attempt to turn gullibility into undeserved profit through exaggeration and lying

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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In an attempt to generalize, it is possible to work out some models representing the conceptual framework of the Chinese and American cultures.

In today’s hectic business environment, it is vital that we are all on the same page, right? But how do we know if we meet those standards? Business owners and executives can avoid the uncertainty, and that’s where ISO 9001 certification comes in.

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