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Do you eat fast food? You must. According to the House of Representatives, the fast food industry is a significant part of our national economy. I

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

t did not become that way be having few customers. Many independent researches have found that fast food is unhealthy and causes weight gain. Th

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

Examples of combination products may in

s research suggests there is something “faulty” with fast food. Our nation is becoming more obese by the day and many obese people are attributi

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

g their weight gain to fast food consumption.

In the documentary Super Size Me, it was proved that eating fast food promotes poor health a

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

d weight gain—even without over eating. In response to this “faulty” product, some are turning to the legal system for justice. However, a cleve

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

Combination pro

ly devised bill was created called the “Personal Responsibility in Food Consumption Act of 2005.” This bill was sent to the house (H.R. 554) and o

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

October 21, 2005 is passed by a vote of 306 to 120. The bill is now in front of the Senate, where it is expected to pass.

The House of Represe

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

ntatives, in this case, found the following:

1. The food and beverage industries are a significant part of our national economy.
2. The activi

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

ies of the manufacturers and sellers of food and beverages substantially affect interstate and foreign commerce.
3. A person’s weight gain, o

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

esity or a health condition associated with a person’s weight gain or obesity is based on a multitude of factors, including genetic factors an

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

the lifestyle and physical fitness decisions.
4. Fostering a culture of acceptance of personal responsibility is one of the most important

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

Following aspects would a

ways to promote a healthier society, lawsuits seeking to blame individual food and beverage providers for a person’s weight gain, obesity or healt

dd to the challenges in developing combination products:

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

condition are legally frivolous and economically damaging.
5. The American food industry is the nation’s leading private sector emplo

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

er.

If you notice in the above findings, the basis of this soon-to-be law is economically motivated and not devised for the betterment of a healt

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

hier society. In their purpose and summary statement, the House of Representatives basically said that fast food establishments should not be he

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

d liable for the damage their products cause due to “over-consumption.” What is interesting is that these fast food companies have never, to my

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

Professional from academic institutions, pharmaceutical industries, health care indust

nowledge, defined what “proper-consumption” is. How can you have over-consumption when you have not defined what proper-consumption is?

If a typi

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

al American simply eats his or her regular three meals a day at a food establishment and his or her health deteriorates as a result, shouldn’t tha

.

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

establish be held responsible for serving a “faulty” product? H.R. 554 is an attempt to remove the liability of food providers and silence the

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

Companies that provide selfless information through particip

egal resource by consumers. The next time you walk into a fast food establishment, see if you can located the “proper- consumption” documentation

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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