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"Privacy?There is no privacy. Get over it!" That comment just a few years ago by Scott McNeely, then CEO of Sun Microsystems, stated a condition that most peopl

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

e did not want to hear. A truth they did not want to believe. And a situation most people refused to deal with.

But in the ensuing years it has become increasi

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

Examples of combination products may in

ngly harder for people to keep their heads in the sand, especially if you are about to undergo media training for an interview with any investigative journalist

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

. You should assume the reporter has details of your private life as well as your private business dealings. This is especially true if the issue your are being

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

interviewed about has been involved in any civil or criminal litigation.

It used to be that only shows like 60 Minutes, 20/20, or Dateline, or select print jo

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

Combination pro

rnalists (Robert Woodward, and the late Jack Anderson, for example) created great discomfort, if not outright panic. on the part of subjects of their investigat

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

ions. These reporters had the staff resources to do extensive and often time-consuming research to get the goods on an interviewee. They also often had the help

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

of whistleblowers inside an organization to leak them negative information.

That exclusivity has changed. Now the internet has made access to "private" record

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

s available, easily and often at little cost. (A Wall Street Journal article, quoting Breit, Drescher & Imprevento PC, gave these figures: credit card transacti

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

ons-$75; full list of assets-$295; list of brokerage accounts-$350.) It has also made public records easier to access. And practice of disaffected insiders to l

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

ak confidential memos and emails seems to continue to gain popularity. With these increased sources of information, even the lone freelancer can now become an i

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

Following aspects would a

nvestigative reporter with clout.

So how do you identify what issues you need to prepare for during media training?

Find out what has already been sai

dd to the challenges in developing combination products:

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

d about you and your organization in the media. List the concerns and questions you will need to address. Here the internet works to your advantage; search engi

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

nes make it easy to find this information.

If you have already been interviewed on this or a related topic, list your quotes the reporters have used.

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

Identify all reports, studies, internal memos (including emails), etc., that contain comments or recommendations contrary to your current position or that

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

contain inflammatory, threatening, or pejorative words or phrases about the opponents. Even when supposedly said in jest, such language creates fodder for tough

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

Professional from academic institutions, pharmaceutical industries, health care indust

questions. And even though they were private, assume that the juiciest will be leaked.

List any personal information (personal or business relationshi

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

ps, financial transactions, investments, contributions, memberships, etc.) that might be embarrassing or cause guilt by association.Now, in conjunctio

.

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

n with your media trainer and pubic relations counsel (and legal counsel if the issue is or likely will be litigated), go through the list and determine how you

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

Companies that provide selfless information through particip

will respond to each issue. The aim is to be able to diffuse the issue so you can maintain your credibility, stay on message, and avoid becoming media roadkill

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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