Advice You - Business

Unless you've been living alone on a desert island with no communication, you know that we'v

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 experienced recently a spate of public figures who have virtually lost their careers becau

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

Examples of combination products may in

se of inappropriate statements that became public knowledge. If only they had received divin

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

guidance in how to manage their personal public relations, they might still be enjoying the

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

ir successful careers. The author has recently discovered an ancient scroll with ten sacred

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

Combination pro

commandments that can ensure that the reader will avoid these public relations pitfalls.

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

r> 1. Thou shalt think – and think clearly and carefully – before thou speaketh or writeth.

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

2. Thou shalt not write or say anything (that is, ANYTHING) that thou wouldst not be p

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

oud to see quoted in the media.
3. Thou shalt never say or write anything that is “off

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

the record,” since thou knowest that in today’s world, NOTHING is off the record.
4. Th

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

u shalt avoid jokes and trying to be “funny” or “cute,” since thou knowest that most humor h

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

Following aspects would a

as a hostile and sarcastic element. Thou shalt leavest the humor to the professional comedia

dd to the challenges in developing combination products:

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

ns and comedy writers.
5. In whatever thou sayest and writest, thou shalt ask, “How wou

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

d someone who hates me interpret this?”
6. Thou shalt keep things positive, and avoid t

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

he negatives.
7. Thou shalt not insult any specific individual or group.
8. Thou 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

alt avoid the temptation to say something controversial, or to offer an “off the cuff” opini

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

Professional from academic institutions, pharmaceutical industries, health care indust

on about anything controversial.
9. Thou shalt offer opinions only within one’s own are

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

as of knowledge, competence, and experience.
10. When in doubt about what to say or wri

.

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

e, thou shalt consult.
The author is not certain which ancient public relations firm

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

Companies that provide selfless information through particip

wrote the above ten commandments. However, their relevance for today's world is unquestioned

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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