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A reporter's job is to get the most accurate and interesting story he or she can. Whether journalists make you look good or bad in the process is inconsequential to them – their loyalty

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

is to their story, and their goal is to elicit the most dramatic quotes possible from you.

This is not to suggest that you should view every encounter with reporters as adversarial. I

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

Examples of combination products may in

n fact, most interviews are quite straightforward. But a good journalist will try to steer you “off message." He or she will use well-established tricks of the trade to get you to say t

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

hings you didn’t intend to say, and some of those things might prove embarrassing when you see them in the newspaper the next day.

By knowing some of the tricks of the reporting trade,

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

you can maintain control of the interview and get the quotes you want. Below are three ways to avoid falling into a reporter's trap:

1) Never Repeat a Bad Question in Your Answer -- I

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

Combination pro

usually starts innocuously enough. A journalist will tell you that because his or her questions will not be included in the story, you should answer the questions in complete sentences

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

.

For example, if a reporter asks, 'Are you pleased with the number of donations your organization received this year?" he or she would ask you to answer by saying, "Our organization i

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

s pleased with the number of donations we've received this year." It makes perfect sense, and is a legitimate way of conducting an interview.

But occasionally, a reporter will ask a ne

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

gative question without warning. You have to break the rules here, and answer the question as a positive.

For example, if a reporter asks you, “Is it true that your organization has co

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

mmitted fraud?" you probably don’t want your quote the next day to say, “It isn’t true that our organization committed fraud." Such a quote links your organization to the word “fraud,"

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

n association you’d probably rather not make.

Assuming, of course, that your business did not commit fraud, you should answer that question in a positive manner, such as, “In our 35 ye

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

Following aspects would a

ars of business, we have always taken great pains to ensure that our business operates within the word and spirit of the law. We have operated ethically in this case, as we strive to in

dd to the challenges in developing combination products:

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

all of our dealings."

2) Shhhhh! -- During most interviews, reporters will ask a steady stream of questions and you will answer them. No surprises there. But remember the goal of the

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

journalist – he or she wants to steer you off message in order to elicit a more interesting response.

Sometimes, after you finish answering the reporter’s question, the reporter will j

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

ust sit there, as if he or she wants you to continue speaking. The silence usually flusters the interviewee, who tries to please his or her interviewer by speaking again – and usually s

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

rays far off message in the process. Don’t fall into this trap! If you find yourself in a “reportorial stare down," simply ask whether the reporter has another question and move on.

3)

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

Professional from academic institutions, pharmaceutical industries, health care indust

Don’t Assume the Reporter Knows What He Says He Knows -- For this one, I’ll turn it over to Eric Nalder, an investigative reporter for the respected San Jose Mercury News. In his artic

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

le, “The Art of the Interview," Nalder writes, “Play like you know. Ask the official why he fired the whistle-blower rather than asking whether he did the deed. The question presumes yo

.

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

u already know even if you don’t have it confirmed. They’ll start explaining rather than denying."

In other words, by falling into this trap, you may be the person who confirms a negat

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

Companies that provide selfless information through particip

ive story about your own organization. If the reporter has made a false assumption, speak up. If not, don’t help the journalist confirm it unless you’ve made a conscious choice to do so

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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