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It is indeed interesting that lawyers sue accountants, doctors and 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

ther professionals for malpractice any time they make the mistake. W

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

Examples of combination products may in

at is interesting about this and perhaps even ironic is that those l

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

awyers on the American Bar Association's Internet Forums often consi

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

er themselves above such suspicion and state that a well-intentioned

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

Combination pro

lawyer who made a mistake should not be punished, because essential

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

y they had meant to do the right thing, but had made an innocent mis

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

take.

Perhaps you have taken Hypocrisy 101 or Rhetoric 202 classes

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

n college and I do not have to explain the absolute double standard

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

that these gentlemen, attorneys attempt to slither under our feet wi

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

h? So, is there such thing as a well-Intentioned Lawyer who Made a M

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

Following aspects would a

stake? Of course there is, just like a well-intentioned accountant o

dd to the challenges in developing combination products:

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

r doctor who has made a mistake. Why should one be sued for mal-prac

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

ice while the other walks away Scott-Free merely because he is a law

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

yer?

Until these double standards are looked at their can be no pea

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 in any professional practice and there will continue to be abuses

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

Professional from academic institutions, pharmaceutical industries, health care indust

of laws by lawyers. Until we face reality and realize that our laws

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

ave been hijacked by these lawyers we cannot fix the problem. The fi

.

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

rst step in solving these mal-practice abusive lawsuits is for us to

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

Companies that provide selfless information through particip

admit we have a huge problem. Perhaps you will consider this in 2006

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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