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SPAM® luncheon meat, made from ham and pork, along with a few other simple ingredients, wa

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

s invented in 1937 by Jay Hormel. Since 1937 over 6 billion cans of SPAM® have been sold.

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

Examples of combination products may in

There are many ways to prepare this all-American classic, and there many recipes that have

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

been developed using SPAM®. There is a lot of great information (and great humor) at the o

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

ficial SPAM® website at:

http://www.spam.com

Did you know that SPAM® luncheon meat playe

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

Combination pro

d a crucial role in the effort of the Allied forces to liberate Europe during World War II?

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

Hormel Foods provided 15 million cans of SPAM® (invented in 1937 by Jay Hormel) to the tro

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

ps each week, and SPAM® quickly became a regular part of their diet. Here is a SPAM® based

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

stew that I developed from a recipe that was said to have been used in the galley of a U.S.

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

Navy ship during WWII.

Griff's American Navy Stew

Ingredients:

2 tbsp. butter

1 clove

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

arlic

1 cup green bell pepper (with membrane & seeds removed), diced

1/2 cup chopped yell

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

Following aspects would a

ow onion

1/2 cup chopped celery

2 cups potatoes, peeled and diced

1 12 oz. can SPAM®

1

dd to the challenges in developing combination products:

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

15.5 oz. can Trappy’s® navy beans flavored with slab bacon (or great northern beans)

2 8 o

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

z. cans tomato sauce

1/2 tsp. dried basil leaves

1 tsp. Lawry’s® seasoned pepper (or blac

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

pepper)

1 tsp. Worcestershire sauce

1/2 tsp. hot pepper sauce

1/2 cup water

Instructio

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

ns:

In a large pan or pot, melt butter over low heat. Add the SPAM® and heat at low temper

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

Professional from academic institutions, pharmaceutical industries, health care indust

ature for a few minutes, stirring frequently. Then add the garlic, bell peeper, onion, and

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

elery and saut? until tender, but do not brown. Then add all other ingredients. Slowly brin

.

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

g to boil, cover and turn down heat and simmer for an hour or until potatoes are tender. Ta

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

Companies that provide selfless information through particip

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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