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Being in debt is no longer a unique situation; most of us at some time in our lives owe money. But it is when you become o

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

ut of your depth that the problems occur being late paying bills or missing the payment altogether incurs late payment cha

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

Examples of combination products may in

rges and fines. These can mount up pretty fast and can add substantially to the debt.

There are however a few ways in whi

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

ch you can grant yourself some “breathing” space if you find yourself in this situation. The key to everything is communic

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

ation; most people will probably see the banks and credit card companies as very hard nosed organisations that have little

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

Combination pro

time for their customer’s problems. But this is not always the case, you need to tell them what’s going on, why you have

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

not paid them and what you intend to do to put things right. If they have no contact with you then they can only assume th

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

t you are not intending to pay them and start sending the letters and fines. If it simply a case that you have arrears tha

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

t you can’t pay right now but will be able to pay in the near future then write to your creditors (the people you owe mone

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

y to), to see if you can arrange a repayment schedule for those arrears. If you feel that you can no longer maintain the m

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

onthly payments then there are some letters you can write to explain this.

These letters assume that you can no longer me

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

Following aspects would a

et the repayments set by your creditor, and that you intend to make them an offer of what you can pay each month.

1. Hold

dd to the challenges in developing combination products:

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

ing letter this tells your creditors that you are having problems and it asks them to tell you the outstanding balances on

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

your accounts, and advises them that you intend to make them a pro rata offer once you have all the information.

2. Offe

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

letter gives details of the offer that you are making them and instructs them to suspend the interest on the account whil

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

e you are paying the reduced amount.

3. No offer letter this assumes that you cannot afford to pay them anything and can

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

Professional from academic institutions, pharmaceutical industries, health care indust

be used if you are out of work or claiming benefits.

All these letters discussed above are available to download from the

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

citizens’ advice bureau website. You can also find out more information about dealing with debt from their site. It is im

.

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

portant to point out that these letters do not constitute a legally binding agreement and the creditors can reserve the ri

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

Companies that provide selfless information through particip

ght to terminate any agreement at any time, however most creditors will see this more favourably than simply doing nothing

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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