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A few weeks ago, I helped facilitate a peer-to-peer conference on HR Strategies on behalf of The New England Mail Order Association (NEMOA). NEMOA was formed in 1947 and is one of the nation’s oldest and largest professional organizations dedicated exclusively to the catalog industry.

In atten

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

dance were human resource and senior management professionals, representing catalog and e-Commerce businesses, both large and small.

One of the subjects discussed at our meeting was I-9 Employment Verification.

The new I-9 Employment Verification legislation is on the verge of passing in Congr

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

Examples of combination products may in

ess, so I thought it would be a good time to give the subject a closer look. It’s a process that’s long overdue for establishing viable work eligibility in the U.S. And with some forward thinking on the part of management, and those responsible for human resources, it should be good news for a

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

smooth, compliant transition.

Mandatory employment verification on the horizon.

Direct marketing organizations, like all businesses, have been collecting I-9 information since the original Immigration and Reform Control Act (IRCA) of 1986, which made it illegal for employers to knowingl

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 hire unauthorized workers.

Although your attention may be focused on your hourly workers—typically high turnover individuals working in warehouse, distribution and contact centers—all employees must meet the same scrutiny.

Part of the IRCA created the I-9 document and the verification proces

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

Combination pro

employers must follow today in order to avoid sanctions. This verification process consists mainly of a physical review of identification documents (e.g., a social security card and a driver license) to establish both the person’s identity and the individual’s authorization to work in the U.S.

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

In the 20 years since passing of the IRCA, the process has changed very little; however this basic and manual process has inherent issues that can result in applicant fraud and error.

Recently, the topic of immigration, and specifically illegal aliens, has reached a fever pitch. With the coo

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

dinated immigration protests across the country on May 1st as one of its high points, the U.S. government has been looking at the employment eligibility issue for some time. It has recently taken steps towards addressing the current challenges.

Step #1
In December 2005, the House t

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

ook action to minimize illegal immigration by taking the first steps to tighten border controls and stop illegal aliens from obtaining employment in the U.S. The bill includes statutes that require, within two years of the legislation passing, all employers to perform an employment eligibility

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

heck directly with the Department of Homeland Security (DHS) for all new employees, or face civil or criminal penalties for hiring illegal workers.

Step #2
In April 2006, the Senate responded to the House bill by sending a bill (S.2612) to the floor called the “Comprehensive Immigra

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

tion Reform Act of 2006.” If passed, the DHS and the Social Security Administration (SSA) will be required to implement a countrywide I-9 Employment Verification database and process. The bill also establishes steep civil and criminal penalties for noncompliant employers.

What does this me

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

Following aspects would a

an for you?

You would still be required to obtain a signed I-9 form, backed by supporting documentation, from each new employee. What’s new is that you would be required to also submit the new hire’s information to the DHS verification system within three days of hire. Also, the law provi

dd to the challenges in developing combination products:

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

es for reassessment of all employees through the system, regardless of hire date, to ensure eligibility to work in the United States.

How does the DHS I-9 Employment Verification work?

The new hire’s information is sent to the DHS database and the system verifies eligibility to work in

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

the United States, verifies that the name and Social Security Number match, verifies the Social Security Number for wage reporting purposes, discourages the use of false documentation and levies penalties for the violation of hiring and/or employment eligibility laws.

What if the result is n

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

gative?

If the DHS search returns as a non-verification, the new-hire must be notified that their eligibility status was deemed non-verified and be given the opportunity to contest. If the applicant does not contest in the time allowed, the non-verification will be final. If they do conte

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

st, the verification will remain tentative until that time the eligibility is deemed either verified or non-verified under further review.

Who must conform?

Until the new law is passed in Congress, I-9 Employment Verification is currently available in all 50 states on a volunteer basis.

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

Professional from academic institutions, pharmaceutical industries, health care indust

If a company decides to participate in the volunteer program, it must screen all new-hires in a search conducted post-hire, within three days of the employee's start date.

While the program is still voluntary until the act is passed, you can count on the fact that the government is serious abo

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

ut illegal immigrants and establishing a program to ensure that work eligibility verification will happen soon. There’s every reason to believe that some version of the “Comprehensive Immigration Reform Act of 2006” will exist and companies should start planning to implement an I-9 verification

.

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

program in the near future.

For more information on the summarized bill “Comprehensive Immigration Reform Act of 2006,” visit the Library of Congress at
http://thomas.loc.gov/ and search for S.2612.

You may also want to check out the servi

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

Companies that provide selfless information through particip

ces of independent, third party employment verification and screening providers.

Much of the information contained in this article was provided through the website of The US Department of Labor, Employment Standards Administration: Compliance Assistance—Immigration Reform and Control Act.

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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