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For many, getting listed on ChexSystems is akin to the kiss of death as it relates to any kind of real banking. ChexSystems, owned by Deluxe, is not the judge, execution

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

er, or jury...rather they are the prison in which you will reside for up to 5 years, once they have listed a negative entry about you in their database.

Listings can ran

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

Examples of combination products may in

ge from minuscule (cents) all the way up to incredibly large amounts, and typically most people have never even heard of ChexSystems until they end up in that database.

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

Banks report their account holders to ChexSystems for any number of reasons (some fair and some not so fair) and they are ultimately the ones who decide if you stay on th

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

list or not.

Reasons for being listed in ChexSystems include but are not limited to:

Overdrafts on accounts that are not repaid in a timely fashion

Misuse of banking

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

Combination pro

cards

Misrepresentation at time of bank account application

Once a person has been listed in ChexSystems there are very few opportunities for removal. The process to g

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

et negative entries removed is almost always arduous and time consuming. And unfortunately, over 90% of US banks utilize the ChexSystems database to verify new accounts,

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

so if you're listed...getting another checking account is next to impossible.

The methods for getting your entry removed from ChexSystems are as follows:

Wait 5 years

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

rom the date of report and the entry will automatically fall off

Dispute the entry. ChexSystems acts as a Credit Bureau and if you have been falsely listed you have the

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

legal right to dispute the entry

Call the bank that reported you and get someone there to “stop reporting” you

While you can get removed from the database, it is rarel

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

y easy for anyone. If you can't wait 5 long years, and the bank has told you to stop calling them, then your only hope is to get the entry deleted. You do attempt throu

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

Following aspects would a

gh their dispute process.

To dispute a negative entry it is imperative you obtain a copy of your ChexSystems report which can be done by going to https://www.consumerdeb

dd to the challenges in developing combination products:

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

t.com/consumerinfo/us/en/chexsystems/report/index.htm

Next you'll want to send them a statement in writing clearly indicating your dispute. Make sure you sign the reque

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

st and mail it (do not phone them) to -

Chex Systems, Inc.
7805 Hudson Road, Suite 100
Woodbury, MN 55125

From there ChexSystems, which is governed by the FCR

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

A (like Credit Bureaus), has up to 45 days to investigate the claim. If ChexSystems cannot verify your entry then they must delete it. If they do not delete your entry

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

they will offer to add a statement to your file...do not ever do that...it's like an admission of guilt. You'd much rather be capable of re-disputing down the line.

Whi

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

Professional from academic institutions, pharmaceutical industries, health care indust

e you are fighting ChexSystems you'll want to try to obtain a checking account through alternate means. You’ll want to research Non ChexSystems Banks and you’ll want to

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

find that 10% that don’t use them yet. They are incredibly hard to locate for even the most resourceful of researchers...but they do exist and can be found if you know e

.

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

xactly where to look.

In closing, most individuals that find themselves in the ChexSystems database have a few different options for getting themselves “de-listed”. Due

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

Companies that provide selfless information through particip

to the amount of time this typically takes, it makes sense to locate Non ChexSystems Banks and establish checking privileges there, at least until your record is cleared

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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