Main Subject - Business

My local Sears store may get sued one of these days because it is still prin

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

ting the full credit card numbers on their sales receipts.

According to the

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

Examples of combination products may in

U.S. Fair and Accurate Credit Transactions Act of 2003, which went into effe

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

ct on December 4, 2006, the retailers are not allowed to print their custome

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

s' full credit card numbers on the sale receipts in an effort to prevent con

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

Combination pro

sumer fraud and identity theft.

Some claim card expiration dates should als

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 be printed but the law is not clear on that point.

Big merchants 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 Rite-Aid, Wendy's, FedEx, TJX, and Ikea are already being sued for doing

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

xactly that.

100 class-action lawsuits are already filed at the federal cou

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

rts and district courts (in California, Pennsylvania, and Kansas) for contin

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

ing to print full credit card numbers on sales receipts.

The lawsuits conte

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

Following aspects would a

nd that the retailers are "wilfully" violating the law, which carry a $1,000

dd to the challenges in developing combination products:

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

penalty per transaction (not per person). So, if a consumer has bought 10 sa

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

ndwiches from a store with 10 different receipts displaying the full credit

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

ard number, the penalty sought would be $10,000.

To prevent the onslaught o

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

f these new lawsuits, VISA started to demand its vendors back in 2003 to acc

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

Professional from academic institutions, pharmaceutical industries, health care indust

pt new machines that print only the last four digits of a credit card number

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

. That still remains the legally accepted practice but I personally see quit

.

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

a few stores still printing their sales receipts the old fashioned way.

I

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

Companies that provide selfless information through particip

guess it's time to have a friendly talk with the Manager of my Sears store..

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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