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Experts estimate that over 70% of businesses doing less than $200 million in sales in some way violate the Federal Wage and Hour Law. In my consulting

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

practice, I am amazed at how frequently I find that clients are unknowingly setting themselves up for potential lawsuits.

(See Chapter 10 in my new boo

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

Examples of combination products may in

k, 30 Ways Managers Shoot Themselves in the Foot for more information on Compensation Opportunities in your business. See Shopping Cart at www.BillLeeOn

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

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Liability for overtime that should have been paid, but wasn’t, can extend as far back as three years and can amount to big

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

bucks if very many employees are involved. Typically, the issue of overtime arises when an employee is terminated and goes to a lawyer to determine th

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

Combination pro

e possibility of filing a wrongful dismissal lawsuit. If there are no grounds for such a lawsuit, an aggressive lawyer may decide to file for overtime

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

violations if the attorney’s research determines that any were committed.

The law requires employers to pay non exempt workers overtime pay for all hou

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

rs worked over 40 in any given week.. To be exempt as an executive or manager -- that is, exempt from this law -- an employee’s “primary duty” must be

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

managing as opposed to doing manual, inside sales or other non executive tasks. This means that the person must spend more than 50% of his or her time

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

on managerial duties. The person must also regularly direct the work of at least two other full-time employees or their equivalent.

In other words, th

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

e person could supervise four people working 20-hour weeks. He or she must also have the authority to hire or fire other employees and regularly exerci

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

Following aspects would a

se discretionary decision making.

In addition, the exempt employee must be paid a salary of no less than $___ per week. (Check with your labor lawyer

dd to the challenges in developing combination products:

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

to determine the exact amount in your state.)

The biggest problem occurs with supervisory workers whom employers consider to be exempt because they thi

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

nk that these employees are managers. But often their duties are split. One week, one of these workers may function as a manager. But the following w

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

eek, the person might be performing a sales or routine office function.

Rule #1 – Be sure to have on file a job description for every exempt employee o

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

n your payroll. The job description should accurately describe the employee’s duties. This will provide some protection if the person later sues for o

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

Professional from academic institutions, pharmaceutical industries, health care indust

vertime on the grounds that he or she was not an exempt managerial employee.

Rule #2 – All non exempt workers should sign a time sheet even if they are

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

not allowed to work in excess of 40 hours a week. If employees are required to sign in and out every time they report for and leave work, it will help

.

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

reduce the company’s liability in future overtime disputes. And of course, these signed time sheets should be kept on file in case you need access to

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

Companies that provide selfless information through particip

them down the road.

If you question whether one or more of your employees qualify for exempt status, you may wish to contact a wage and hour consultant

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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Trying to keep everyone informed and up to date by sending a blizzard of e-mail doesn't work, and just increases people's stress levels. Here's a better way.

A job fair represents a good opportunity for job seekers to meet with the job offers in persons, meaning with the employing companies representatives. If you are looking for a job, a job fair is an event you shouldn’t miss. You will have the chance to interact personally with the employers and you will get a glimpse on the companies inside.

What makes one business person different from another, and different from an employee. Read on - and put on your thinking caps!

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