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In late 2005, victims of both Hurricane Katrina and Hurricane Rita we

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

re allowed to file for bankruptcy without facing many of the filing

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

Examples of combination products may in

equirements most debtors are forced to deal with. After losing everyt

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

hing, many hurricane survivors wouldn't qualify for bankruptcy under

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

he restrictive new law.

The United States Department of Justice waiv

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

Combination pro

d the new requirements for all residents of communities devastated by

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

these hurricanes. The Bankruptcy Abuse Prevention & Consumer Protect

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

on Act of 2005 would have prevented untold numbers of people displace

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

d by the hurricanes from filing for the bankruptcy protection they de

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

perately needed.

Requirements that were lifted for Katrina and Rita

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

urvivors included:

• The means test
• Mandatory credit counseli

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

Following aspects would a

ng
• Documentation to avoid collection actions

Additionally, an

dd to the challenges in developing combination products:

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

survivors that needed to go to a creditors’ meeting were allowed to

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

meet with their creditors at a meeting place close to where they live

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

currently, even if in another state. Representatives of the United St

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

te Trustee Program, a division of the Department of Justice, were giv

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

Professional from academic institutions, pharmaceutical industries, health care indust

en the responsibility of setting up any required creditors’ meetings.

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

The lifting of the restrictive new bankruptcy requirements hopefull

.

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

y helped many survivors who lost everything, to pick up the pieces an

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

Companies that provide selfless information through particip

get on with their lives without crushing debts weighing down on them

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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