Answers - Finance

These days it seems every where you turn car dealers are trying to sell you on leasing a car instead of buying. While leasing may be

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

good for some, for the majority of people it is not. Here are a few things to watch out for when negotiating a lease, and yes just li

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

Examples of combination products may in

ke a purchase they are negotiable.

When you lease a car you need to pay particular attention to the terminology for what you are res

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

ponsible for at the end of the lease. Sometimes they charge a vehicle disposition fee which I have seen as high as $500! They may cha

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

rge you for excessive mileage, excessive wear on tires, etc. Let’s take a closer look at these things.

First off, we have the dispos

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

Combination pro

ition fee which is the fee charged by the leasing company or bank if you decide to turn the vehicle in instead of buying it at the en

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

d of the lease term. The fee is usually described as necessary to cover expenses that the company will incur to sell the vehicle such

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

as getting it ready to sell, auction expenses, and commissions. Be sure that the fee is stated clearly and remember that you can neg

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

otiate.

One of the biggies that nails a lot of people who lease is the excess mileage charge. Nearly all leases charge these penalti

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

es; as a matter of fact I have never seen one that didn’t. These charges can add up quickly with some companies charging as much as 3

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

0 cents per mile for every mile over the mileage allowed in the contract which is typically only 10,000 to 12,000.

I don’t know abou

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

Following aspects would a

t you but I drive more than that and so do most people. The average is around 15,000 miles a year. This can be negotiated into the le

dd to the challenges in developing combination products:

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

ase so be sure that you get extra miles upfront, it’s a whole lot cheaper that what you will pay on the backend.

Another way that yo

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

u get stuck is by vague “excess wear and tear” clauses. You need to make sure it is spelled out in the contract what the definition o

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

f excessive wear and tear is. If there is no description telling you what the standards are that they go by then it will be up to 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

leasing company and the person inspecting the car when you turn it in and you will left holding the bag. If you have minor damage yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

u are better off having it repaired yourself than turning it in and letting the lease company handle it. They will always charge more

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

than what you can get it done for.

My suggestion as a former automobile sales manager is that if you are stuck on leasing that you

.

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

make sure you stay under the mileage allowed, keep maintenance records, repair any damage, and get the vehicle looked over and apprai

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

Companies that provide selfless information through particip

sed before turning it end at the end of the lease. If you have all of your records in this way you are far less likely to be hassled.

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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Answers - Read The Small Print And Avoid Extra Costs At The End Of Your Lease

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