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OVERCOMING FEAR OF FIRING “It was obvious that this employee could not relate well to clients. But

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

I could not bring myself to fire him.… and while I wavered, things only got worse for everyone in 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

he department.” Having to fire someone is one of the most difficult actions any manager or executiv

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

e may have to take. It is an action that many manager’s find endless excuses to avoid, as did the e

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

ecutive quoted above. Yet, in certain cases it is unavoidable. Firing is a managerial art that many

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

Combination pro

otherwise successful supervisor’s neglect to develop.

WHEN IS FIRING APPROPRIATE? Most people tak

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

e pride in and care about their job responsibilities. There are some people, however, whose pride 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

n their job is, unfortunately, unwarranted. Others, exist who don’t think pride enters into it — th

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

t “a job’s a job” .Still others are of the belief that they deserve a job because of their circumst

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

ances, or their longevity, not necessarily because they are working up to standard. Some people gen

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

uinely need a job, but cannot do the quality of work necessary to sustain their position. When the

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

Following aspects would a

needs of an individual staff member come into serious conflict with the needs of the group, the man

dd to the challenges in developing combination products:

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

ger must place higher priority on the well-being of the group. The manager must look beyond the ind

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

ividual needs to the survival of the organization.

LAYING THE GROUNDWORK: The best method for avoi

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

ding the negative consequences of the firing process involve laying the groundwork, with actions th

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

at should be taken long before the final decision to fire is made. All personnel working in an orga

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

Professional from academic institutions, pharmaceutical industries, health care indust

ization should know, from the day they are hired, what actions or behaviors on their part can resul

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

t in their being fired. These policies should be in writing, and they should be given to all employ

.

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

ees or posted in a conspicuous place. Employees have a right to know these ground rules. Once they

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

Companies that provide selfless information through particip

know them, their responsibility to abide by them should not be subject to question at a termination

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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