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There are many types of harmful medical mistakes and potential mistakes for which

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

malpractice suits, and threats of malpractice suits, represent virtually the onl

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

Examples of combination products may in

y control. The problem with lawsuits to correct these actions is that identificat

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

ion is often random and incomplete, and frequently the suits respond to bad luck

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

rather than bad practice. The suits may do more harm than good in the following w

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

Combination pro

ys:

1. Interfere with and even destroy trusting patient-physician relationships.

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

Physicians come to view patients as litigants.
2. Over ordering of invasiv

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

e tests to prevent the long-shot, bad luck case.
3. Tendency to cover-up mi

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

stakes to prevent lawsuits.
4. Increasing the cost of medicine by many obvi

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

ous ways.
5. Failure to distinguish truly bad physicians from those who wer

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

victims of bad luck, good physicians are lumped together with bad. We still can'

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

Following aspects would a

t tell which physicians are in need of discipline.

I am sure many physician

dd to the challenges in developing combination products:

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

s do try very hard to practice good medicine and don't let the threat of malpract

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

ice influence their practice. But this is the real world, and physicians are huma

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

n first. For some doctors, avoiding lawsuits is very important as lawsuits are de

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

astating in more ways than I can enumerate.

And this is troubling. Unfortunately

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

Professional from academic institutions, pharmaceutical industries, health care indust

, it's like democracy itself. Lawsuits are the worst system for controlling malpr

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

actice. Except for any other system that we have. I would like to see an honest a

.

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

ppraisal, free of hype and blame, that would benefit patients and the medical sys

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

Companies that provide selfless information through particip

tem. We can do better, but first we have to recognize what works and what doesn't

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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