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I turned on the television news recently to learn that one of our top football teams may have lost an important match because of illness, the story being brought to us by a reporter stationed outside the hotel where the players enjoyed lunch prior

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

to the game.

In the car, this was the lead story on the radio news with the story read by a reporter, again said to be outside the hotel. He confirmed that the Police had collected samples from the restaurant to pass onto the health authorities.

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

Examples of combination products may in

Guess what? The story was also the lead in the tabloid newspapers sat on my desk when I reached the office. Photographs of the hotel in question usually supported the story.

As a public relations professional, I reflected on what the hotel’s PR pe

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

ople are going through this morning. This is a prestigious hotel group with a well-crafted brand image of quality at the premium end of the market. Here they are, in the spotlight for all the wrong sort of reasons!

They will surely have a document

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

d Crisis Management Plan or, in softer terms, a PR Communications Plan. But it is not only global companies who need to devise a plan in advance. Being in business, or even running a not-for-profit organisation, exposes everyone to the risk of a PR

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

Combination pro

crisis.

No organisation is very far from crises and their resulting media attention. Their reputation can be washed away or seriously damaged in an instant. A crisis is any situation that threatens the integrity or reputation of your company, usu

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

ally brought on by adverse or negative media attention.

These situations can be any kind of legal dispute, theft, accident, fire, flood or manmade disaster that could be attributed to your company. It can also be a situation where in the eyes of t

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

e media or general public your company did not react to one of the above situations in the appropriate manner. This definition is not all encompassing but rather is designed to give you an idea for the types of situations where you may need to foll

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

ow this plan.

Crisis management is a complex subject, but here are five tips to get you started. And, start, you must.

1. Don't wait. Many organisations only get their crisis plans underway once a disaster has struck. Instead, brainstorm possible

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

scenarios or types of disasters that could happen, and start planning for them. In fact, I have found this to be a positive process as bringing together key executives to share ideas and examine scenarios often brings out a range of issues that th

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

y can take forward.

2. Realise that crises take a wide range of shapes. As I say, this can be anything from the hotel’s crisis to a legal dispute getting out of hand to customer dissatisfaction aired on the Internet. I even recall a weekend phone

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

Following aspects would a

call from a Scout leader whose campsite had been washed away in storms with some children being injured; the media were on the telephone badgering her for the story! They will all require slightly different responses. Brainstorm and prepare for as

dd to the challenges in developing combination products:

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

many as you can imagine.

3. Develop a PR communications plan. A barrage of media attention may swamp you within minutes of the news breaking. Also, think about how you will get information out to staff, supporters & investors, and customers – yes,

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

remember to get your side of the story out to customers as soon as you can. Internal communication is as important as communication to the general public.

A physical plan has to do with getting everyone out of the building in case of an earthquak

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

. A communications plan involves identifying a spokesperson, developing press releases, setting up a media hotline, and finding a place where you can have a press conference.

4. Be prepared to speak to the media and to your constituents. Even if y

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

ou can't say much because your lawyer is concerned about liability, plan to say what you can as soon as you can. Be concerned, show concern, speak concern, and always tell the truth. That doesn't mean you have to tell everything all at once, but ne

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

Professional from academic institutions, pharmaceutical industries, health care indust

ver, never lie.

5. Provide media training for senior management. Do this before a disaster strikes. Make it a regular part of board and senior employee training. Media training needn't cost a lot if you have someone on your board working in public

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

relations or someone who is a member of the media. The key is to do it regularly so that new people are always trained and others don't grow stale.

Don't delay your crisis planning. Don't ruin your hard-won reputation by handling difficult situati

.

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 badly! The directors and PR team of that hotel this morning went to bed last evening little knowing the blast of unwelcome publicity that was facing them this morning. Hopefully, their PR Communications Plan will be a trusted aide today!

Sugge

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

Companies that provide selfless information through particip

sted reading

1. "Crisis in Organizations: Managing and Communicating in the Heat of Crisis," by Laurence Barton.

2. "You'd Better Have a Hose if You Want to Put Out the Fire: The Complete Guide to Crisis and Risk Communications," by Rene A. Henry

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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