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While speaking at a recent legal seminar on internal investigations, an attorney asked me about responding to

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

news media that finds out about an emerging corporate crisis or other potentially negative situation.

Isn’t

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

Examples of combination products may in

t in the company’s best interests, he asked, to avoid the press until all the facts are known and there’s some

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

“good news” to tell?

Nope. You can’t dissuade interested reporters from chasing down a legitimate business st

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

ry any more than you can push water uphill with a fork. Not only do your pants get wet, but you look an idiot

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

Combination pro

In other words, the news happens with you or without you. It doesn’t matter that you don’t have all the fac

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

s, or still have lose ends to tie up. Unlike the lawyerly concept of a definitive final resolution, news cove

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

age is incremental. Hour by hour. Day by day. One headline follows another as new information is confirmed

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

r disputed, as ramifications become evident and fall-out analyzed.

And in almost all cases, how your compa

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

y responds to and deals with the press becomes part of – and at times the central focus of -- the ongoing stor

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

.

To not participate in even “negative” news coverage is to risk death by a thousand paper cuts. You for

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

Following aspects would a

e the media to discover for themselves the facts that you don’t have -- information, opinions and perspectives

dd to the challenges in developing combination products:

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

that will be rushed into coverage whether or not you agree with their accuracy or context. In the end, you li

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

ely prolong whatever bad publicity you’re trying to avoid.

Does that mean you have answers to every question?

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

Of course not. But there’s a huge difference between hiding from the press and making a sincere effort to ex

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

lain why you can’t answer a specific question, or why it isn’t appropriate for the CEO to be interviewed at th

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

Professional from academic institutions, pharmaceutical industries, health care indust

s time. Engaging the media during an emerging crisis -- even to respectfully decline comment -- promotes a cr

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

dible rapport that may create breathing room to produce facts as you confirm them, or have opportunity to resp

.

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

nd to information and opinion before it is published or aired.

Whether you’re dealing with good news or bad n

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

Companies that provide selfless information through particip

ws, the rule is the same. Say only what you know to be true. But say it. Your company will be better for it

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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