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KEEP WRITTEN RECORDS: “Document !Document! Document!” Keep a record of periodic performance reviews, incidents of unsatisfactory perfor

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

mance, conferences where warnings are administered or terminations are announced. Issue warnings and terminations in writing as well as

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

Examples of combination products may in

verbally. When dealing with a particularly unstable or vindictive employee, request that the employee sign a written summary of a warn

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

ing or termination conference to attest to the fact that the summary is accurate (not that they necessarily agree with it).

DOCUMENTAT

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

ION SERVES TWO PURPOSES: First, it insures that the message has been conveyed. All people’s memories of conversations are distorted by

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

Combination pro

emotions and expectations. So it is quite likely that an employee coming out of an emotional warning conference will have a faulty memo

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

ry of the specifics, unless the memory is aided by a written summary. Second, documentation provides insurance for post-termination con

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

frontations. If the employee challenges a firing, either before an owner, a board, or an unemployment claims officer, claiming that ade

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

quate warning was not given or that the firing was groundless, a written record of the entire process should provide sufficient evidenc

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

e to counter these claims.

KEEP EMPLOYEES INFORMED: A means of avoiding potential confrontation is for the manager is to keep his boss

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

up-to-date on the situation. For a manager who is also the owner of the business, of course, there is no one else to turn to. However,

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

Following aspects would a

if the executive director answers to a board, owner, or sponsoring group, the appropriate party should be consulted as soon as the pos

dd to the challenges in developing combination products:

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

sibility of a termination arises. The privacy of the employee must be respected, so prior consultations should be made in confidence. O

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

ne executive director kept the board’s chairperson advised, rather than discussing the situation with the full board. When the terminat

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

ed employee appealed to the board, the chairperson was able to verify the director’s account of the process.

SUGARCOATING A WARNING: 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

ince warning conferences can become quite emotional, key messages sometimes fail to get communicated. Sometimes managers and directors

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

Professional from academic institutions, pharmaceutical industries, health care indust

try too hard to cushion the blow by sugarcoating the warning. In one instance a manager went to such lengths emphasizing the employee’s

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

strong points in addition to the problem areas that the employee left the meeting unaware that he was close to being fired. A second m

.

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

essage is often necessary clearly outlining the specific steps the employee needs to take to meet the manager’s expectations. To avoid

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

Companies that provide selfless information through particip

miscommunication, have the employee state his interpretation of the manager’s message to be sure he has an accurate understanding of 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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