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If your company relies on at-home workers to perform some of your company's job responsibilities, you may be doing two things: You may be categorizing the cottage labor as independent contractors, and you may be paying them for "piece work," and not paying

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

them for overtime or benefits, no matter how many hours they work.

If this is the case, and the federal labor board catches up with you, you could be in big trouble.

Somewhere around the mid-1990s a lot of U.S. companies got the idea that, if they recla

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

Examples of combination products may in

ssified their workers as independent contractors, they could avoid paying income and social security taxes, unemployment insurance, and a host of worker benefits, from health insurance to pension payments. Thousands of workers found themselves out of a sta

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

ble job and in the position of being considered contract workers, suddenly responsible for paying their own income taxes and both their own and their former employers' share of social security and Medicare taxes. At this point the federal government cracke

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

d down, defined the difference between employee and contractor status very strictly, and set about enforcing the rules.

One of the biggest distinctions between an employee and a contract worker is whether a worker has any flexibility in performing his or

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

Combination pro

her duties. If workers are expected to keep to a regular schedule at the discretion of the company, if they have to perform the work according to specific parameters, and if they cannot turn down work without negative consequences (for instance, being barr

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

ed from additional work when available), then they are employees and need to be treated as such. Contract or freelance workers should have much more flexibility in their work arrangements, should be able to define what work they will and will not perform f

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

or the company involved, and should be able to accept or reject assignments, within reason, without being cut off from further work. The relationship between a contract worker and a company is more of a professional service provider / client relationship.

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

Another mistake commonly made by employers of at-home workers is not keeping track of the hours put in by cottage laborers, and taking that into account regarding compensation and benefits. The danger comes when an employer utilizes both in-house and at-h

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

ome employees, and offers overtime and benefits to their in-house employees but not their cottage labor.

An example: A particular company employs about 30 in-house employees, paying them an hourly wage, paying their income, social security, and Medicare t

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

axes, and offering health insurance, a 401K plan, vacation pay, and an Employee Assistance Program (EAP). The company also employs 30 at-home workers, offering them a combination of hourly wages and "piece work" wages, on a per-job basis. The at-home worke

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

Following aspects would a

rs receive no overtime if they work over 40 hours in a week, no benefits, and may or may not have employee status. They don't know when or if they will receive work in the course of a particular day, but are expected to be on hand to do the work if called.

dd to the challenges in developing combination products:

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

The work may arrive at 9 a.m., at noon, at 2 p.m., or at the end of the day.

This employer is breaking the law.

While employers can choose whether or not to provide benefits such as health insurance, vacation pay, etc., for employees, they cannot

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

offer these benefits to one group of employees and not another; if in-house employees who work 40 hours a week are entitled to benefits, so are the at-home employees who work an equal number of hours. Even if the at-home employees are paid entirely by pie

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

ce work, the employer is required to keep track of the hours they work and use a formula to come up with an hourly equivalent, based on the rate of pay to determine if the hours worked make the worker eligible for benefits.

The employee is also eligible,

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

by federal law, for overtime for work in excess of 40 hours a week; this is not an option. If an employee must wait for work during the course of a day, that employee is entitled to pay for the time spent waiting for work, from the beginning of the work da

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

Professional from academic institutions, pharmaceutical industries, health care indust

y, up to the time they pick up the work. So if a workplace begins work at 8 a.m. and the at-home employee doesn't receive work until 2 p.m, and spends six hours thereafter performing the work, that employee must receive six hours' pay for waiting and anoth

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

er six hours' pay for the work actually performed, or a total of twelve hours. It's not hard to see that if an at-home employee is expected to be available for work five days a week it's very easy to qualify for overtime and benefits.

Employers ignorant o

.

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

f these facts or who choose to ignore them are vulnerable for severe sanctions. A disgruntled employee who chooses to drop a dime on such an employer can single-handedly initiate a complete federal audit which can result in payment of back pay and benefits

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

Companies that provide selfless information through particip

for every employee affected, on top of some pretty stiff fines.

The lesson? Know the law, obey the law, and treat your employees - all of your employees - fairly. The alternative can be pretty grim.

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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A thoughtful attempt at drawing a correlation between an adequate personnel security program and due diligence in illustrating how vulnerable any business, organization or system actually is. It further illustrates how personnel with access pose the greatest risk by virtue of their knowledge and freedom of movement. Taken for granted is that group of personnel that fall in the category of service providers.

For more sales, better service, happier customers and employees, get Sales and Service working hand in hand. Customers experience both sides – each should support the other.

If you are planning to buy a business some day, or if you already have one, and want to know a secret way to expand quickly without begging a bank or lender for the money, then this article will show you how. I recently did an interview about buying businesses and a guy from Florida emailed the following question in:

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