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In this great country, the land of the free, where people died to give us the freedom not to have to pay a tea tax to England, there is a great injustice going on, that would make our fore fathers roll over in th

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

eir graves! (Well, they'd be spinning if they knew everything!)

I am writing today to protest a couple of things that I think should be illegal, that we in America, are allowing to remain legal. You may have already gue

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

Examples of combination products may in

ssed one of the things: Non Sufficient Funds charges. I am referring specifically to the charges charged even though the bank has not paid anything. Well the other one is unique to only 2 or 3 banks, I believe, but it i

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

worse! Namely: The deduction of debits at the end of the day, before the addition of credits!

Don't get me wrong here, I think the bankers may be justified on their NSF charges, when they pay the charge.

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

But to deduct $35-40 just to tell so-and-so that the money isn't there, should be illegal. I know that they need to send the person who overdrew their account a letter, but that can't possibly cost more than $5.00.

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

Combination pro

(39 cents, I believe!). To charge $35-40 is extortion, and just for saying “no”?! Now , maybe if they pay the charge, the fee is called for. But I am disputing the legality, or the continuation of that legality, of banks

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

charging fees for no service. Refusing to pay an overdraft is not a service.

There are laws in place to set a cap on what credit cards can charge for interest. Why aren't there laws in place to reign in the banks, who

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

charge exorbitant fees, on money they didn't even lend? And to make it illegal to count the debits before the credits? Now, I am not an attorney, but isn't there someone out there besides me, or with me, who can see that

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

this shouldn't be legal?

My family has been through some rough times recently. We have 9 children, and my husband's business equipment was stolen, which made it pretty much impossible to continue in that line of work.

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

We suspect someone got high on meth for awhile. Through a misunderstanding on the cost of insurance, the equipment was not covered. So, we bit the bullet, and have been looking for something else. In the meantime, certa

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

in automatic charges were due to come out, and somehow, we would get the money “just in time” we thought, on the day the charge was to come out, only to learn, and/or be reminded that they deduct the debits first. Due t

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

Following aspects would a

o the laws put in place the last time a fuss was put up about the bank NSF charges a few years ago, they are not allowed to “discriminate”, and only one NSF charge can be refunded per year. The problem is, they shouldn't

dd to the challenges in developing combination products:

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

be taking out the charges in the first place, since it should be illegal to count the debits before the credits. But this is what my bank (Key bank) gets away with.

So, if you ask me, the big fuss a few years ago only b

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

enefited the bank, not the customers who complained.

I am writing a letter to the Comptroller of the Currency to protest this injustice, and I encourage anyone, and everyone to do the same, that has had a problem. If yo

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

u haven't had a problem, I urge you to stand with us, anyway, because there should be “liberty and justice for all”, right?

When those that are “down” are stepped on, it hurts the society because it creates even greater

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

eed, and causes tremendous stress and anger in our society. We personally, are forgiving people. We ask the bankers to reverse the charge, they say no, but I admit to a sadistic comfort in knowing they'll think about th

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

Professional from academic institutions, pharmaceutical industries, health care indust

is in the hereafter (to be “politically correct”). But I can see where people can be pushed over the edge on something like this, so I'm doing what I can to change what they can do legally: not just for myself, but becau

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

se I can see that it should be illegal.

We need to be brave enough to take up this cause, or surely we will continue to loose even more freedom.

To file a complaint about a bank, write a letter to Customer Assistance Gr

.

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

up, 1301 McKinney St, Suite 3450, Houston, TX 77010. Call the Comptroller of Currency for a confirmation of this address, and to know what they want you to include with your letter. Their number is: 800-613-6743.

I urg

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

Companies that provide selfless information through particip

e you to also send a letter to the attorney general, as I am going to, and to Senators, the President, or whomever else may be able to get laws passed to stop this extortion.

To your freedom, and to that of all Americans

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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