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After the miracle diet drug, Fen Phen, was introduced in the early 90’s, nearly 6.5 million people consume

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

d the drug. The reason for such a large consumption was the immediate weight loss associated with the drug

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

Examples of combination products may in

. However, after ties between Fen Phen and the fatal Primary Pulmonary Hypertension were established, Amer

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

ican Home Products removed the drug from the market in mid September of ’97.

While Fen Phen supporters di

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

not want to believe the horrible side effects that would befall some, they soon came to the realization t

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

Combination pro

hat the drug was quite harmful. Soon after Fen Phen was pulled from American shelves, evidence implicating

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

AHP of withholding serious knowledge of the harmful side effects the drug would cause came to light.

Sin

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

e millions of people had taken the diet drug Fen Phen, a large percentage of these people were experiencin

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

g drastic side effects, and in some cases even death. Many people say they would pay any price to lose wei

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

ght. However, death was not the price they wanted to pay.

A large number of the lawsuits filed in state c

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

urt were filed because of the different effects Fen Phen caused on people’s health. The people filing suit

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

Following aspects would a

were seeking some type of compensation for the rising medical bills they were incurring.

In late 1997, e

dd to the challenges in developing combination products:

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

very single federal Fen Phen case was transferred to the United States District Court. This event started

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

a series of nationwide Fen Phen settlements. In mid-November of 99, preliminary approval was given to the

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

ettlement class. In order to find that the agreement reached in the settlement was fair, the district cour

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

t held a hearing.

In August of 2000, the settlement agreement was awarded approval. Thus creating the Ame

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

Professional from academic institutions, pharmaceutical industries, health care indust

rican Home Products Settlement Trust. After attempts to overturn the court’s ruling, the AHP gave in to th

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

settlement.

If you are a patient who has suffered from PPH (Primary Pulmonary Hypertension) caused by 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

e diet drug Fen Phen, then you should know that you are not part of the settlement agreement with AHP. All

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

Companies that provide selfless information through particip

Primary Pulmonary Hypertension patients are required to file independent lawsuits to make any legal claim

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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