Main Subject - Business

Do you have a crisis management or crisis communications plan for your business or organization? Do you believe your business or organization is

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

too small to need a crisis communications plan? Or do you believe that crises only happen to others?

If you are like the majority of businesse

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

Examples of combination products may in

and organizations today, especially small to medium sized ones, you answered NO to the first question and probably YES to the second question.

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 I hope you answered NO to the third question.

Well, I cannot emphasize too strongly that no matter how big or small you are, every organizat

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

ion should have a crisis management and crisis communications plan.

If you read the newspapers or watch the news on TV or hear the news on the

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

Combination pro

adio, you know that crises happen every day. No person or organization is immune from crises. Think about such recent crises as fires, bank robb

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

ries, corporate scandals, sexual harassment, product recalls, death of top executives, closing a facility, etc.

So what should you do? The answ

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

er: develop a crisis management plan in 2 parts. The first part is the crisis management plan (how your company or organization will deal with t

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

e crisis at hand to minimize negative impacts). The second part is the crisis communications plan (how you will communicate with the media and t

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

e public about the crisis).

Too many companies prepare one without the other. Both are critically important. Your goal needs to be that most cr

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

ses will never get reported in the media because you handled the situation skillfully enough that it never became visible to the media. And the

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

Following aspects would a

development and implementation of a good crisis communications plan will help make sure of that.

Some great tips and techniques for your crisis

dd to the challenges in developing combination products:

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

management program can be found on the Public Relations Society of America website. General principles that can positively affect your actions

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

nd communication in a crisis situation.

Crisis communication planning can help you deal effectively with those unexpected disasters, emergencie

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

s or other unusual events that may cause unfavorable publicity for your organization.

Before the crisis, successful communication will depend,

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

n large part, on the preparations you make long before the emergency occurs.

During the crisis, your focus is to deal with the situation, gathe

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

Professional from academic institutions, pharmaceutical industries, health care indust

accurate information and communicate quickly.

Reporters provide few surprises in a crisis situation.

Your spokesperson should be forthright i

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

n dealing with media questions. There are, however, some questions he or she simply cannot and should not answer.

Your spokesperson should not

.

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

espond to media questions with "no comment" because this answer can imply a lack of cooperation, an attempt to hide something or a lack of conce

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

Companies that provide selfless information through particip

n. There are more appropriate responses when he or she either doesn't have one or is not at liberty to give certain information after the crisis

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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