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Layoffs are part of corporate America. Several times a year the business section of the newspaper mentions another large layoff at well-known companies. One of the biggest layoff announcements of the year 2005 has been made by

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

General Motors. GM wants to layoff about 30,000 of its employees. Several other companies have made similar announcements and more are to expect - sooner or later. This can happen almost anywhere and in any industry.

Employees

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

Examples of combination products may in

fear these layoffs as it seems it is not predictable and inevitable to be laid off. Up to a certain percentage this might be a true statement. As an example – if a whole location or plant is being shutdown layoffs will hit almo

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

t everyone. But if only 10% of the workforce is being laid off it feels like gambling. Who will be the victims? Nothing the individual employee can do about it until the actual layoff happens. But this does not necessarily need

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

to happen. Recent studies have shown that employees can make strategic moves to avoid being put on the list of workers to be laid off.

Corporations use large layoffs to secretly get rid of employees that they would have proble

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

Combination pro

s with getting rid of other otherwise. Often the fear of being sued by a departing employee has them avoid to fire employees in other situations, but when a large reduction workforce is being announced it is much easier to incl

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

ude certain employees in the layoffs and to take away touchy situations that would lead to expensive law suits. So, instead of firing or laying off troublesome or expensive employees as isolated incidents these layoffs gets “qu

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

ued” and included into larger rounds of layoffs – effectively disarming the risk of being sued. But it’s not always the troublemaker who gets included in layoffs, it’s also employees that do not perform well, employees that und

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

rmine the moral, employees that expensive and not productive, and employees that just don’t seem to fit into the corporate culture.

Here are some items that eventually get an employee onto the list of workers to be laid off. B

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

aware that you will never find official documentation about this. These are unwritten rules executed by many corporations across the board. These reasons will eventually be distributed verbally, but you will never find a writt

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

n statement about them. Increased risk of being selected as an employee to be laid off during large reductions in workforce comes from taking extended time off from work. This can be a medical or family leave or extensively usi

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

Following aspects would a

ng all available sick days. Another item that can get an employee onto the list is openly complaining about a manager. Being seen gossiping around the office is another reason to silently make it onto the list of layoffs. Being

dd to the challenges in developing combination products:

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

the guy or gal that is member of committees that try to do good at work (organizing social events, getting more company money spend non-work related items (e.g. a gym at work, TV in the kitchen, etc.) can also be a reason. Why

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

ou might ask? Well, these activities are usually done during business hours and the employee is much less productive. The employee might only work 50% of the available, but is being paid a full salary. Employees who eventually

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

rive up prices for group health insurance could be at risk, too. Also, employees trying to get workers organized in a union could also be at risk to be put onto the overall list of employees to be laid off. By going through 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

s list it is easy to identify a pattern. Employees who interrupt the overall work process for themselves and others are seen as less productive and more expensive for the business. Employees who use company provided benefits ex

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

Professional from academic institutions, pharmaceutical industries, health care indust

tensively do cost the company a lot of money.

By releasing these workers at the same time when general cost cutting is needed, the savings affect for a business can partially increase additional 20% - 40%. Get rid of your most

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

expensive and least productive employees and the cost savings are optimized. Once those “problem” employees have been identified, businesses will select the remaining employees to make it onto the list based on departments that

.

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

are subject to layoffs – the normal procedure when trying to eliminate 10% of a workforce. The “trouble making” employees now have less chance to sue the company about being laid off. To make a connection between generic cost c

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

Companies that provide selfless information through particip

tting layoffs and to be laid off because of their work habits or personality during those situations is very difficult to prove for employees. And again – there will be rarely a written memo about these kinds of strategic moves

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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