Answers - Legal

The American Disabilities Act was designed to help the physically challenged and handicapped,

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

unfortunately the laws and regulations were so comprehensive they had serious unintended conse

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

Examples of combination products may in

quences from coast to coast. The rules were too stringent and costly to small businesses and 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 used them to sue many companies right out of business. The idea behind the ADA rules ma

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

e sense, but the consequences have been dire for many businesses. In the end the ADA should be

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

Combination pro

no problem and it should be great for all concerned.

Indeed. But at the end of the day shoul

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

da, woulda, coulda isn't good enough. Some poor small business gets the shaft and loses their

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

chance at the American Dream due to these unintended consequences. We cannot excuse the linear

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

thought process of lawmakers and/or lawyers who go out of their way to sue under the letter of

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

the law, intent of the law or some case law in some kangaroo court somewhere (whatever serves

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

their particular case at that time). Additionally the tort laws in this nation are insanity.

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

Following aspects would a

So, the system is broken and it makes hard chargers really think twice about participation in

dd to the challenges in developing combination products:

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

the over all lie. Too many insane regulations and too many lawyers (terrorists), thus business

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

es move to places with fewer regulations. We need a reality check in this county. It is way ov

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

er the top and drown in political correctness. And it is not righting itself, we are taking on

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

water and I am concerned we will lose this ship. Although we do not deserve such a grand ship

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

Professional from academic institutions, pharmaceutical industries, health care indust

to sail as we lack responsibility in our society for such an important task.

There can be no

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

excuses for these actions or this over regulation. It is not okay to chock it off as unintende

.

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

d consequences as it now known and should be fixed. If not it is to accept it and live in medi

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

Companies that provide selfless information through particip

ocrity and that of course is un-American and therefore unacceptable. Consider all 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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