Answers - Legal

On Thursday, May 25, 2006, in a historic vote, the U. S. Senate passed the most significant immigration reform law in 20 years. This comprehensive immigration reform bill addresses 3 difficult problems: 1) securing our border

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

s; 2) creating a temporary guest worker program to address labor shortages; and 3) what to do with the estimated 12 million undocumented immigrants in the country.

The bill now goes to the House/Senate conference committee w

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

Examples of combination products may in

ere it must be reconciled with the House bill which was past last December. The House bill only deals with the first issue: "securing our borders". It is "enforcement only". The rationale behind it is that first we need to re

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

ssert control over our borders. It proposes to build a 700 mile fence along the border with Mexico, adding 6,000 new border patrol agents, and it makes "unlawful presence in the US" into a felony. It also calls for more "inte

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

ior enforcement" that is cracking down on employers, who employ undocumented workers. It raises the maximum fine for knowingly employing an undocumented worker from $10,000 to $40,000 and it includes criminal sanctions for re

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

Combination pro

peat violators. The Senate version also calls for stiffer enforcement in the workplace, doubling the penalties for employers from $10,000 to $20,000.

The Bush Administration has proposed two new reforms to insure that employ

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

rs are employing workers who are authorized to work in the US. First, they have proposed that employers be allowed to keep I-9 employment authorization forms electronically in digitized form. This would save space and also ai

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

in searching them. Second, they have proposed new procedures for employers setting forth their duties and responsibilities when they receive "Social Security mismatch" letters, indicating that their employees social security

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

numbers and names do not match with their account. The regulations will establish safe harbor procedures for employers. However, they will also target employers for enforcement procedures if they repeatedly receive the mismat

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

ch letters. Hopefully, Immigration reform will be approved this year and they will be able to legalize those workers whose documents are not appropriate. However, if a new law creating a temporary worker is not approved, empl

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

yers must be prepared to deal with the increased workplace enforcement which is expected.

Regardless of what the final immigration reform bill looks like or even if no bill passes at all, one thing is certain - there will be

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

Following aspects would a

increased enforcement of employer sanctions. Just as the IRS made all employers into deputy tax collectors, Immigration is making employers deputy immigration inspectors, by requiring them to complete form I-9 for all employe

dd to the challenges in developing combination products:

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

s and also by now requiring them to verify the accuracy of their employees' social security numbers when they receive "mismatch letters" from the social security administration. The immigration reform bill has proposed the cr

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

eation of an electronic data base for employers to verify their employee's social security numbers. Enforcement of employer sanctions has already increased and will increase substantially.

At this time, it is uncertain what

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

he final immigration reform bill will look like or whether it will pass at all this year. However, one thing is certain - there will be more enforcement in the workplace, with or without a new law. Right now, due to all of 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

political pressure, Immigration has already started to enforce the existing laws more vigorously. Therefore, it is incumbent upon all employers to conduct a "preventative internal I-9 audit" now, before they are audited by t

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

Professional from academic institutions, pharmaceutical industries, health care indust

e government. Employers are required by law to complete a Form I-9, Employment Verification Form, for all of their employees at the time of hire, certifying that they have reviewed the employees documents and that they are au

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

thorized to work in the US. This is required for all employees, even native born US citizens. Further, if an employee's work authorization expires, the employer is required to fill out a new I-9 form with the updated informat

.

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

on. Failure to do so may subject the employer to civil and criminal penalties.

For further information on conducting a preventative internal I-9 compliance audit, contact Eli M. Kantor at (310) 274-8216; ekantor@beverlyhills

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

Companies that provide selfless information through particip

mmigrationlaw.com or dreli173@aol.com; or go to our website at www.beverlyhillsimmigrationlaw.com or our blog at www.beverlyhillsimmigrationlaw.blogspot.co

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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Secured personal loans are also loosely known as homeowner loans. The interest rates are lower, the repayment term greater and a bigger amount can be borrowed. Lenders require some collateral as security to approve these loans.

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