E-Articles - Health and Fitness

64.5% of Americans are currently overweight or obese. The rate of increase in obesity is twice as high for children as for adults

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

In the United States, obesity now contributes more to chronic illness and health care costs than does smoking. In fact, 7% of a

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

Examples of combination products may in

l health care expenditures can be attributed to obesity.

One fourth of all vegetables eaten in the United States are French fries

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

Even if you are a parent committed to healthy eating for your child, they will eventually go to playgroups, birthday parties, s

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

chool where they will see billboards, watch TV, go to movies, and travel the supermarket aisles where their favorite Disney or Public TV

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

Combination pro

haracters are linked with sugared cereals, yogurt, snack foods, and ice cream. You face Goliath.

They have recently had to change

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

the name of Adult Onset Diabetes to Type 2 Diabetes because so many children are getting the disease these days. In fact, today’s obese c

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

hildren who develop Type 2 Diabetes may need coronary bypass surgery before they are 30 years old.

Ronald McDonald can be found

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

n every McDonald’s market in the world. He speaks over 25 languages and is the second most recognized figure to children in the world—jus

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

under Santa Claus.

10-15% of all calories consumed by America’s teenage girls currently come from soft drinks.

In the 19

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

0’s we began encouraging snacking—relatively unheard of before this decade. We even invented brands like Snack wells, Snack Healthy, etc.

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

Following aspects would a

We have became a culture that embraces “bigness”….we drive SUVs, have big 4 bedroom homes, drink big gulps, eat big macs, etc.<

dd to the challenges in developing combination products:

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

li>

Restaurants, airlines, and movie theaters have made their seats larger to accommodate our increased girth. Even clothing sizes are

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

larger today than they were 30 years ago.

It’s not just the fast food and soft drink industry. Massive agribusiness companies hav

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

e tremendous lobbying power over our government. They often put their business interests over public health. These giant corporations inf

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

uence what crops the government subsidizes, which commodities are shipped to schools for the National Lunch program, whether soft drinks

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

Professional from academic institutions, pharmaceutical industries, health care indust

re sold in schools, even which foods are emphasized in the food pyramid.

We attack and recognize big industry in this country suc

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

h as the massive oil industry, the large tobacco companies—what about the giant food industry?

We are a country that values prev

.

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

ntion programs for children. You see this on warning labels for toys that pose a choking hazard, car seats, immunizations programs...yet,

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

Companies that provide selfless information through particip

we know that food preferences, even brand loyalties are formed early in childhood and we do little to prevent childhood obesity?

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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