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It seems to happen every week: someone is caught saying something that they immediately wish they could take back. Even seasoned professionals like Don Imus say things they wish they hadn’t.

While Imus said that he used those infamous three words “as a

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

joke,” most people certainly didn’t think it was a laughing matter. In our view, the situation was made worse because virtually every time the media reported on the incident, they repeated those three words. It was truly a story that took on a life of it

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

Examples of combination products may in

own, for several reasons. First, the apologies didn’t really seem sincere. Pointing out that it was intended as a joke in essence placed the blame on those who “misunderstood” his innocent comments rather than on Imus.

Second, Imus’ employer was very d

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

elayed in its response to the situation. And, while they said that their decision to suspend, then terminate, his employment was based on his inappropriate comments, it was also clear to many that the decision to fire Imus was made only after many compan

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

es cancelled their advertising. Thus, people were left with the impression that if the ad dollars were still there, Imus would be, too.

How does this pertain to corporate America? On a smaller scale, we’ve all seen things like this happen to CEO’s and o

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

Combination pro

her executives and managers. Typically, it happens at company meetings or in some form of communication with employees, clients and/or the public. It also happens during interviews. To put it simply, something is said that shouldn’t have been said. Maybe

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

it was a joke that went bad; maybe it was a private comment overheard on a “live” microphone; maybe it was a draft of a memo that was distributed rather than a final – or a host of other incidents. The point is, how does someone recover and remove their

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

foot from their mouth?

Everyone makes mistakes and we all realize that. What often makes the situation deteriorate is either trying to ignore the problem or worse, trying to cover it up or blame someone/something else. Apologize – and make it sincere or

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

don’t bother. Issuing a disingenuous statement can often make the situation worse. In its initial statement regarding the Imus remarks, MSNBC said that “Imus in the Morning” is produced by another radio station and they were simply simulcasting it. Thei

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

statement went on to say that Imus makes it clear every day that his views are his own and may not be the views of MSNBC. While they did say the comments were inappropriate, they did it in a way to say “Gee, it really wasn’t our fault so you can’t blame

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

us.” The problem was, however, that many people did blame them for the comments.

Imus did apologize – but not until the next day when there was already an uproar. If you say something inappropriate, you probably know it right away, even if it’s b

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

Following aspects would a

ased on the reaction of others. Don’t delay as time is of the essence. If you’re making a speech at the all-employee meeting and you tell a bad joke, immediately say, “Wow, I’m sorry. I shouldn’t have said that.” Then, go on with the rest of your speech.

dd to the challenges in developing combination products:

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

Don’t belabor the point.

While you can explain your comments, don’t make excuses. Recently, a political candidate blamed one inappropriate remark on: 1) the batteries going out on his hearing aid and being deaf in the other ear, 2) needing to use the ba

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

throom, 3) having both the flu and bronchitis, and 4) misinterpreting the question. Wow. The fourth reason was the only reason he should have given. And, if the question was indeed misinterpreted, a clarification of his original answer should have been p

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

ovided.

If you’re giving an interview, always make sure you understand the question. While some reporters love getting a “sensational” comment, the majority are far more interested in receiving accurate information. The same goes for your employees and

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

ustomers.

One important thing to keep in mind is the context of your remarks. What Imus said directly referred to Rutger University’s women basketball players. However, those same three words are often totally overlooked when they are in a rap so

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng. Your joke may be appropriate in a management team meeting, but could be misinterpreted in an interview with the local business reporter.

Of course, the best way to avoid “open mouth, insert foot” disease is to prepare before you make your com

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

ents. Very few people are good at true extemporaneous speaking. Here are a few tips:

- Know your subject matter inside and out.
- Anticipate both positive and negative questions and plan your answers in advance.
- Know when to tell a joke…and

.

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

when not to. More importantly, recognize if you can tell a joke well! What sounded funny on Letterman may be very different when you bungle it.
- Practice, practice, practice! Whether it’s an all-company meeting, an interview or a shareholder meetin

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

Companies that provide selfless information through particip

, don’t try to speak unprepared.

Finally, recognize that you may not think your remarks were inappropriate but others may. Examine each situation to determine if you do need to clarify your remarks or issue an apology. Sometimes, silence truly is golden

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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Of course my wife said I didn't know what I was doing and my friends also were skeptical and thought that I was completely wasting my time.

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