Cases - Business

Paperwork. Nobody likes it, but everyone has to do it. Documentation on a new hire can be the most cumbersome, but is an absolute must. Detailed paperwork not only allows the new employee to collect a paycheck

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

and be eligible for fringe benefits, it protects you, the employer.

Take for example the required I-9 form. Failure by the employer to properly document all new employees and their legal ability to work can resu

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

Examples of combination products may in

t in major fines and penalties.

The Law

The law governing I-9 states that an employer is prohibited from knowingly hiring or knowingly continuing to employ an unauthorized worker.

The Employer Responsibility

T

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 employer is responsible for ensuring that their employees are authorized to work in the U.S. The completion of the I-9 Form and inspection of the supporting documents helps to establish that individual’s identi

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

y and work eligibility.

I-9 Forms must be fully completed and signed on the day the employee begins work. It is important to note that even though the employee completes Section 1, the employer can still be liabl

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

Combination pro

e for any violations or omissions. Therefore, it is important that the employer thoroughly check the document and supporting legal documents provided by the employee.

The employer must review original verificati

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

n documents presented by the employee and complete Section 2 of the I-9 form within the first three days of hire. Even if the individual is hired for 3 days or less, the entire form must be completed. In this ca

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

e, you need to complete it at the time the employee begins work.

Common Questions

Here are a few common questions taken from the Immigration & Naturalization Service (INS) Publication, "Handbook for Employers: I

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

structions for Completing Form I-9" (11/91)

What should I do if the person I hire is unable to provide the required documents within 3 business days of the date employment begins?

If an employee is unable to pre

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

sent the required document or documents within 3 business days of the date employment begins, the employee must produce a receipt showing that he or she has applied for the document. In addition, the employee must

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

present the actual document to you within 90 days of the hire. The employee must have indicated on or before the time employment began, by having checked an appropriate box in Section 1 that he or she is already e

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

Following aspects would a

igible to be employed in the United States.

What happens if I properly complete a Form I-9 and INS discovers that my employee is not actually authorized to work?

· You cannot be charged with a verification viola

dd to the challenges in developing combination products:

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

ion. You will also have a good faith defense against the imposition of employer sanctions penalties for knowingly hiring an unauthorized alien, unless the government can show you had actual knowledge of the unauth

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

orized status of the employee, if you have done the following:

· Ensured that employees fully and properly completed Section 1 of the I-9 at the time employment began;

· Reviewed the required documents which sho

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

ld have reasonably appeared to have been genuine and to have related to the person presenting them;

· Fully and properly completed Section 2 of the I-9, and signed and dated the employer certification; · Retain

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

d the I-9 for the required period of time; and

· Made the I-9 available upon request to an INS, DOL (Department of Labor), or OSC (Office of Special Counsel) officer.

Can I fire an employee who fails to produce

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

Professional from academic institutions, pharmaceutical industries, health care indust

he required documents within 3 business days?

Yes. You can terminate an employee who fails to produce the required document or documents, or a receipt for a document, within 3 business days of the date employment

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

begins. However, you must apply these practices uniformly to all employees. If an employee has presented a receipt for a document, he or she must produce the actual document within 90 days of the date employment

.

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

egins.

Potential Penalties

The employer’s first time penalties range from $100 - $3,000 depending upon the nature of the offense. Companies which engage in a pattern or practice of knowingly hiring unauthorized

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

Companies that provide selfless information through particip

workers may face fines of up to $3,000 per employee and/or six months' imprisonment.

Your safest bet is to always remain proactive in completing the necessary forms and to verify all supporting documents promptly

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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Cases - The Employer's Role in Verifying Employment

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