Actual - Legal

The Securities and Exchange Commission thought it might be a nifty idea for C

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

orporate Board of Directors to have fewer insiders on them so they would serv

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

Examples of combination products may in

the will of the shareholders and not allow corporate executives to do so muc

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

hanky panky and keep getting such big bonuses. Unfortunately, as nice as thi

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

little nifty idea was it is somewhat a socialist projection into the America

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

Combination pro

Corporate Board Rooms.

Now we see that at Hewlett Packard, a Board of Direc

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

or not so beholden to the company has been spying and giving priviledged, ins

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

der and proprietary information to news reporters who then put it out on the

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

ssociated Press undermining the company and causing stock prices to drop, the

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

efore hurting shareholders equity and share valuations. Whoops? Looks like th

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

law of Unintended Consequences due to over regulation and meddling rears its

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

Following aspects would a

ugly head again.

But the story gets worse. The CEO of the company wanted to

dd to the challenges in developing combination products:

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

find out who was leaking information and a private investigator was hired. Tu

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

ns out the private investigator used “pre-texting” and that really goes again

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

t the grain of regulators trying to curb identity theft, even though Federal

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

egulators use the very same trick to track down abuses.

Looks the SEC, which

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

Professional from academic institutions, pharmaceutical industries, health care indust

wanted more Board of Directors in American Corporations who were not Insiders

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

now has egg on their face for pushing such a policy in the first place, but w

.

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

should not be so surprised, as this is just one of hundreds of regulations,

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

Companies that provide selfless information through particip

hich results in the Law of Unintended Consequences. Consider all this in 2006

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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