Answers - Legal

Many people understand the inherent issues in free markets with corruption, mob style att

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

acks on competitors and the need to protect consumers from fraud and theft. In our nation

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

Examples of combination products may in

we have regulations on business that often are too restrictive for us to continue to cal

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

our economy one of Free Markets.

Those who defend such intervention and lambaste the la

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

isse faire motif say things such as; “If economic markets were free, the government would

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

Combination pro

't interfere. If the markets were manipulated, the government would interfere.”

Pardon m

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 French but that is absolute BS, Government interferes in free markets every day, thus m

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

anipulates them. The regulators un-level playing fields that give an edge to Corporate Am

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

rica against small business, but indeed large corporations do not need an edge over small

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

business, as they are so much more well financed.

If a large corporation cannot compete

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

with smaller businesses, then it is not correctly using its economies of scale and is the

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

Following aspects would a

refore inefficient. If regulators allow lobbyists and politics to interfere they are not

dd to the challenges in developing combination products:

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

assisting free-markets they are doing the exact opposite of intent or perpetuating fraud

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

hemselves.

Does it matter if the if the human bureaucrat in the bureaucracy is corrupt o

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

r incompetent in their regulation endeavors? No, either way they are causing damage to my

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

nation and my people. It is time for them to come clean, admit their actions are hurting

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

Professional from academic institutions, pharmaceutical industries, health care indust

not helping and join with us in solving these issues.

We need a reality check on free ma

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

rkets and government over regulation. I certainly hope this article is of interest and th

.

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

t is has propelled thought. The goal is simple; to help you in your quest to be the best

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

Companies that provide selfless information through particip

in 2007. I thank you for reading my many articles on diverse subjects, which interest you

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 - Can the Government Regulators be Trusted with Free Markets?

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