Advice Pool - Business

I am a former American Express employee. I worked for the company for eleven years, from 1990 to 2001. I then returned last year for a very short stint (about two months-couldn’t handle it- they hired me for collections!) I will certainly never bash them or bad-mo

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

uth them. They are an excellent company to work for.

From my experiences there, I have come to realize that many people could use some education about how the American Express Charge card products work. A charge card isn’t like a credit card. A charge card must b

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

Examples of combination products may in

e paid in full every 30 days. This is great for people who have a good deal of money in the bank, or those who own small businesses. The advantages of using the American Express card as opposed to just using your bank debit card are:

All kinds of great points goi

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

g towards incentives
Extended warranty protection on purchases (yes, even cars).
You get to keep your money in the bank for an extra amount of time.
They send you a statement at the end of the year if you have certain types of accounts (gold, platin

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

um, small business) that will help you when you get ready to file your taxes. This way you can have the expenses organized in one account. The list goes on.

But, exactly how does a charge card work? How do you know how much you can spend every month? This is the

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

Combination pro

mystery question. This is what this article is about.

A charge card doesn’t have an established line of credit. A big gray area. At American Express, your ability to charge is based upon a few factors. The first one is your established payment and spending histor

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

with the company. If you’re new, you don’t have one. So, after that, the next consideration is your FICO score (or CBR score). It’s a number between 350 and 830. The higher you are to 830, the better you are as a credit risk. And last, your debt to credit ratio.

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

This means, how much of the credit that’s been extended to you have you already used. Are you overextended already? American Express will know that.

Do you have a mortgage and you think that proves you’re a good credit risk? Wrong. If you have a mortgage, America

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

n Express considers you a greater credit risk because of your large monthly debt.

You’re a small business owner. You have one of those “Open” accounts from American Express. Your first month, you charged $10,000 and paid it back in full within the 30 day grace pe

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

iod. The next month, you’ve already got a balance of $30,000 and suddenly you get a phone call from American Express. They are politely advising you that you can’t put any more charges on your account until they receive a payment. You are astonished. “I thought th

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

is card didn’t have a credit limit”. Your bill isn’t even due, you just received it in the mail three days ago.

The poor rep on the phone has to explain to you all of the things I mentioned above (payment history, CBR score, debt to lending ratio, etc…) Now you a

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

Following aspects would a

re furious because this is the only card you intended to use to run your business.

To make it more complicated, you can also have a revolving account attached to your small business account, which allows you to have a line of credit to be used for some purchases.

dd to the challenges in developing combination products:

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

And, guess what? Even if you pay the charge card portion of your account on time every month, if Amex deems that your revolving balance has become too high, you can still receive that phone call.

The bottom line for small business accounts: if you intend to spend

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

at least $150,000 per month, they strongly suggest you go ahead and give them your financials. Meaning, if you have that much in liquid assets, provide proof. You don’t want to run into an embarrassing situation if you can avoid it. God only knows how many times

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

I got chewed out for things like this. But if you don't intend to spend that much, say you want to spend $10,000 a month, you may have to build your way slowly over the space of a few months (maybe three or four) by demonstrating that you have the ability and the

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

ood intention of paying back smaller amounts. For instance, you spend $2000.00 the first month and you pay it back in full, on time. The second month, you spend $4000.00 and do the same, and so on. You steadily build your ability to spend without interruption. And

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

Professional from academic institutions, pharmaceutical industries, health care indust

yes, there are some card holders who can spend $10,000 the first month, without being questioned. That is solely based on all of the factors I mentioned above (CBR score, debt to income ratio, etc…).

There’s also the option of pre-paying the account if your acc

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

ount is fairly new. Yes, we had customers who had the money (and were smart enough) to figure out that if their account was very new, they could send us $75,000 and charge that much and more. Understand that with a charge card, you are building a relationship of t

.

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

ust. It’s not a nickel and dime sort of account. If any of this frightens you, I’m doing you a favor. There is tremendous prestige in having an American Express account, specifically a charge card. American Express also treats those who maintain their relationship

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

Companies that provide selfless information through particip

in good standing very generously. They highly expect that you will be doing business with them for the next twenty or thirty years (and many customers do). So learn the rules and you can do well with your account, whether it’s to run your business or personal use

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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