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Every organization has issues that could affect its operation. The following are some tho

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

ughts on issues management and some of the tactics available to us in this discipline.

F

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

Examples of combination products may in

irst of all, what is the objective of issues management? Typically, it is to proactively

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

nd responsibly identify and manage emerging or existing issues that can have an impact on

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

our:

* assets

* position

* image

* competitiveness

* performance

Now, some compani

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

Combination pro

es become obsessed by issues management and dissect every small problem they foresee. We

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

elieve that keeping it simple is best. Identify a few issues that are most likely to mate

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

rially affect you, determine the key concern each issue holds for you, determine how urge

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

nt it is, prepare an action plan, and then mount a focused attack.

Tactically, there are

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

a number of weapons available. First, is a strong, credible image. A proactive program to

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

maintain this image could include:

* an issues audit

* media monitoring to detect exis

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

Following aspects would a

ting or emerging issues of importance

* aggressive media relations on issues of prime im

dd to the challenges in developing combination products:

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

ortance

* reprints of favorable media coverage for distribution

* a letter to the edito

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

r program that involves employees and allies

* development of alliances with natural par

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

tners

* writing of editorial/opinion pieces for submission to major media

* development

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

of position papers on key issues and distribution to employees and allies as well as to m

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

Professional from academic institutions, pharmaceutical industries, health care indust

edia

* legislative briefings for state and local officials on key issues

* identificati

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

on of "neutral" experts who agree with our positions

* identification of other organizat

.

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

ons to whom we can "hand-off" some issues

* public opinion research on issues of importa

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

Companies that provide selfless information through particip

nce

* speakers bureau

* identification of opponents and initiation of dialogue with the

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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The challenge: How a US company with offices throughout the EU can comply with the notice and choice principles of EU Data Protection laws while simultaneously complying with the whistle blower requirements under Sarbanes Oxley?

Sometimes a business needs the ability to control its advertising and what better way than to do it through their own in-house agency? But is it worth it? You Bet!

The trend towards outsourcing will continue to grow as market pressures force corporations to be more tightly focused on core business functions, gaining competitive advantage and reducing costs. Outsourcing is an attractive alternative in good times and bad times.

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