Advice Pool - Insurance

Many experts are forecasting an increase in weather related disasters. The effects of global

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

warming are becoming more obvious and changes in weather patterns may be related to this.

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

Examples of combination products may in

In the United States hurricanes are the most destructive weather related events. Major hurri

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

canes usually result in major flood damage. The year 2005 was the worst year for flood damag

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

e in recent history. FEMA generally considers a significant flood event to be when 1,500 los

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

Combination pro

ses are paid in a single event. In 2005 FEMA rated 5 hurricane related events in the signifi

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

cant event category. An event with a billion dollars paid in FEMA flood claims would be cons

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

idered as especially large.

FEMA flood losses paid for hurricane Katrina were in excess of

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

15 billion dollars. The actual damages were far greater because many homes and business did

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

not have flood coverage. Total damages are estimated at over 80 billion dollars. In addition

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

to economic damages more than 1,800 people lost their lives in Hurricane Katrina and in rela

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

Following aspects would a

ted floods. The effects of damage and impacted lives from this storm will linger for years.

dd to the challenges in developing combination products:

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

There is a list of major flood events available at cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

e.com/floodevent.html" target="_blank">www.Texas-Flood-Insurance.com/floodevent.html.

T

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

here will certainly be hurricane and flooding events in the future. The government and indiv

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

iduals are making efforts to be better prepared for future events. There has been a lot of g

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

Professional from academic institutions, pharmaceutical industries, health care indust

ood information for individuals on how to prepare for a major storm and or flooding. One les

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

son from recent flooding is that many people overlook flood insurance. Homeowners insurance

.

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

doesn’t cover flooding and it is necessary to get a separate policy if you want flood covera

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

Companies that provide selfless information through particip

ge. Most flood policy’s are backed by the federal government and the cost is very reasonable

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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